- Email: [email protected]
Promoting clinical research to medically underserved communities: Current practices and perceptions about clinical trial recruiting strategies
Contemporary Clinical Trials 41 (2015) 39–44
Contents lists available at ScienceDirect
Contemporary Clinical Trials journal homepage: www.elsevier.com/locate/conclintrial
Promoting clinical research to medically underserved communities: Current practices and perceptions about clinical trial recruiting strategies Andrea Tanner a,⁎, Sei-Hill Kim a, Daniela B. Friedman b,c, Caroline Foster d, Caroline D. Bergeron b a
School of Journalism and Mass Communications, University of South Carolina, Columbia, SC, United States Department of Health Promotion, Education, and Behavior, University of South Carolina, Columbia, SC, United States c Statewide Cancer Prevention and Control Program, University of South Carolina, Columbia, SC, United States d College of Charleston, Charleston, SC, United States b
a r t i c l e
i n f o
Article history: Received 29 September 2014 Received in revised form 15 December 2014 Accepted 16 December 2014 Available online 23 December 2014 Keywords: Health promotion Clinical trial Recruitment Research participation
a b s t r a c t Introduction: Although clinical trials have the potential to provide the most advanced medical treatments and screening options, accrual rates remain low among medically underserved populations. Strategies to enhance clinical trial recruitment are frequently undertaken without developing, implementing, and evaluating communication and educational activities. This study assesses the current clinical trial recruiting efforts taking place at academic medical centers in a southeastern state and explores principal investigators' attitudes and beliefs about how to successfully recruit for clinical trials, in the general population, and in African American and rural communities. Methods: An online survey was used to collect responses from clinical trial principal investigators working in a southeastern state's five main academic medical centers. Respondents were asked about their experience with recruitment and recruiting strategies, in general, and in the African American and rural communities. Results: Respondents said that it was most difficult to find rural residents to participate in clinical trials (M = 3.60, SD = .93), followed by the general public (M = 3.30, SD = .99) and African American residents (M = 3.15, SD = .99). Investigators most often reported personally recruiting their patients (M = 3.50, SD = 1.34) and through local doctors (M = 2.80, SD = 1.20). Principal investigators rarely recruit through faith-based organizations (M = 1.74, SD = 1.05), or by using radio (M = 1.62, SD = .90), or television ads (M = 1.42, SD = .75). Conclusion: Clinical trial investigators rarely communicate about clinical research outside of the medical setting or partner with community organizations or local doctors to reach individuals in medically underserved communities. Study implications describe the importance of educating research teams about how best to promote clinical trial awareness and knowledge. © 2014 Published by Elsevier Inc.
1 . Introduction Clinical trials (CTs) are essential to the advancement of public health and medical research in the areas of prevention, ⁎ Corresponding author at: School of Journalism and Mass Communications, Carolina Coliseum, Office 4011C, University of South Carolina, Columbia SC, 29201, United States. Tel.: +803 777 6827. E-mail address: [email protected] (A. Tanner).
http://dx.doi.org/10.1016/j.cct.2014.12.010 1551-7144/© 2014 Published by Elsevier Inc.
diagnosis, screening, treatment and quality of life, yet recruitment of patients into CTs continues to be an enormous challenge [1]. Failure to meet CT recruitment goals is common [2]. Such recruitment failures often jeopardize the quality of a study, delay the development and evaluation of new therapies, and can lead to an increase in costs to the health care system [3]. Despite the lack of participation, CT research continues to be a priority for academic medical centers and research funding agencies [3] and is considered the gold standard for evaluating
40
A. Tanner et al. / Contemporary Clinical Trials 41 (2015) 39–44
the effectiveness of treatment or preventive procedures on humans [4]. Although it has been nearly 20 years since the NIH established guidelines for the inclusion of women and minorities in clinical research [5], current accrual rates into CTs are low among minority and other medically underserved populations, including African American (AA) and rural residents regardless of disease, type of trial, or sponsoring agency [1,6–12]. The barriers to CT participation have been studied extensively, with these barriers primarily falling into two categories: patient- and physician-related barriers. Patient-related barriers include cognitive barriers, such as lack of awareness or understanding about CTs [13], structural barriers, which include concerns about participation costs, travel and insurance coverage [14], and psychological barriers, including misperceptions, distrust, and fear [15]. Physician-related barriers include limited knowledge of ongoing CTs, unsupportive attitudes, and a lack of motivation to enroll patients [16,17]. Traditional strategies to recruit participants into CTs include posting flyers and sending recruitment letters to local physicians [3,18–20]. Other methods used to enhance trial participation, particularly in underrepresented populations, include the use of clinical registries and electronic health records [3], recruitment through community organizations, and use of media and educational outreach [21]. Few studies have evaluated the effectiveness of CT recruiting strategies [22]. Strategies to enhance CT recruitment are frequently undertaken without a comprehensive plan to develop, implement, and evaluate communication and educational activities [23] and there is a need for additional research focusing on CT recruitment strategies. The purpose of this study is to evaluate how CT principal investigators (PIs) utilize various CT recruiting strategies to enroll patients. No studies, to our knowledge, have explored the communication and recruitment strategies of CT PIs at academic medical centers and their perceptions of the importance of specific recruiting tactics. The objectives of this study were to 1) describe the current recruiting efforts at academic medical centers in a southeastern state and 2) explore PIs' attitudes and beliefs about how to successfully recruit for CTs, in the general population and in AA and rural communities. The authors' long-term goal is to incorporate this important formative research into the development of a comprehensive communication and educational plan to increase enrollment in a wide array of CTs. 2 . Methods 2.1 . Study participants and design This research consisted of an online survey of CT PIs working in a southeastern state's five main academic medical centers. These medical centers are all affiliates of a statewide biomedical research collaborative committed to transforming South Carolina's (SC) public health and economic well-being through research (http://www.healthsciencessc.org). According to the U.S. Census Bureau [25], SC is a state with a sizeable African American (AA) population (e.g., 28.0% of the SC population is AA versus 13.1% nationally) that is also largely rural (e.g., 25 of SC's 46 counties are designated as nonmetropolitan (i.e., rural) with 39.5% of the state's population living in rural areas, compared to 21.0% nationally) [26]. All but one of the medical centers were located in three largest cities in
SC, and all were within close proximity of rural areas of the state [24]. We first developed a sampling frame, as efforts to locate contact information for CT PIs working in these academic medical centers revealed no such resource. The clinicaltrials.gov website, which provides information about federally and privately supported CTs, includes contact information for trial sponsors, but not for CT investigators. We searched hospital websites and contacted institutions' research offices to ask for PIs' names and email addresses. These efforts resulted in an attempted census of CT PIs from the five academic medical centers in the state. To complete the sampling frame, we distributed our online questionnaire via email sent from the hospitals' Institutional Review Board (IRB) directors to the hospitals' PIs. Our sampling frame included the names and email addresses of 417 PIs. In June and July 2011, an email was sent to each PI requesting his or her participation in a web-based survey, which included a link to the questionnaire. Three follow-up emails were sent to increase the response rate. After nonworking email addresses were purged from the list (n = 35), the revised sample frame included 382 PIs. Ultimately, 119 (31% of working addresses) respondents completed the online questionnaire. Where the reported sample is less than 119, it indicates that not all respondents answered all the questions. In most cases this was because it was not relevant to the respondent and the online survey software automatically omitted the question, but in other cases, the respondent may have forgotten to answer or chosen not to answer. The survey was administered using the online survey tool Qualtrics, a subscription-based survey site (Qualtrics.com). The IRB at the authors' university approved the survey instrument. 2.2 . Study variables Respondents were asked how difficult it is to find people, ingeneral, and from rural areas and AA communities to participate in their own CT research (five-point scale ranging from “very difficult” to “very easy”). Respondents were also asked if they make extra effort to recruit from rural areas and AA communities in SC. We also asked about the recruiting strategies the PIs employ to recruit CT participants. Using a five-point Likert scale ranging from “never” to “always,” respondents were asked how often they use recruiting strategies involving traditional methods of recruiting, including patient databases and personal recruitment by the PIs. They were also asked about their use of community partnerships to recruit participants. These items included recruiting through community organizations, such as the YMCA, community health organizations, faith-based organizations, local doctors, or social services or work organizations. How often they used different promotional strategies, including printed materials, such as flyers, brochures, and posters, and advertisements in various media outlets was also assessed. A battery of questions ascertained CT investigators' perceptions of the importance of different CT recruitment strategies, in general, and in the AA and rural communities. Respondents were asked to rate their level of importance from “not at all important” to “extremely important” on a five-point scale with 13 possible strategies for recruitment, including make CT information more accessible and available in a variety of forms
A. Tanner et al. / Contemporary Clinical Trials 41 (2015) 39–44
and languages, make information and consent forms simple and short, provide patients and general public with a list of CTs available at the hospital, provide patient education and seminars, provide community outreach and education, communicate through printed materials (posters, pamphlets, church bulletins, etc.), communicate through mass media (TV, radio, newspaper, etc.), be aware of information overload and stresses faced by patients, be honest and open with patients, provide monetary reimbursement or incentive for participation, provide transportation, provide childcare, and provide flexible scheduling of appointments. The literature on CT recruitment strategies was used to develop these questions [18,21,22]. Several demographic and contextual variables were also assessed. PIs were asked about their credentials, years of CT experience, the focus of trials conducted, including prevention, screening, diagnosis, treatment, quality of life and expanded access, and specific type of CT such as cancer, diabetes, reproductive health and mental health.
41
Table 1 Current Recruiting Strategies of Clinical Trial Investigators at SC Academic Medical Centers. How often do you recruit potential patients through: (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; 5 = Always) 1. Personal recruitment by investigators 2. Local doctors 3. Patient databases 4. Printed materials (e.g., flyers, brochures, posters) 5. Print ads (e.g., newspapers, magazines) 6. Community organizations 7. Community health organizations (e.g., rural health clinics) 8. Social services/work organizations 9. Internet 10. Federally qualified health centers 11. Faith-based organizations 12. Radio ads 13. TV ads
Mean
SD
3.50 2.80 2.64 2.58 2.03 2.01 1.85
1.34 1.20 1.32 1.36 1.15 1.15 1.03
1.84 1.82 1.75 1.74 1.62 1.42
1.04 1.07 .98 1.05 .90 .75
2.3 . Data analysis Descriptive statistics, frequencies, and paired sample t-tests were generated. All statistical analyses were conducted with SPSS Version 18. 3 . Results Eighty-three percent (n = 99) of respondents self-identified as a PI, a CT manager, project manager or recruiter (12%, n = 15), research associate (4%, n = 5), nurse (3%, n = 3) or “other” (4%, n = 5).1 Years of experience working with CTs ranged from 1 to 40 years, with a mean of 11.3 years. Cancer (n = 66) was most often identified as the specific disease or condition being studied, followed by reproductive health issues (n = 32), cardiovascular disorders (n = 30) and diabetes (n = 20). The most common focus of research was treatment of illness or disease with nearly three-quarters (71%, n = 85) of respondents indicating that they conducted at least one trial focusing on treatment in the past two years. This was followed by prevention (34%, n = 41), quality of life (31%, n = 37) and diagnosis (29%, n = 33). Respondents (n = 93/119) agreed that it was most difficult to find rural residents to participate in CTs (M = 3.60, SD = .93), followed by the general public (M = 3.30, SD = .99) and AA residents (M = 3.15, SD = .99). Significant differences were found between the perceived difficulty in finding rural residents as related to participants from AA communities (t(df = 83) = 4.255 p = .01) and the general public (t(df = 86) = 2.985 p = .01). Few respondents (36%, n = 33/93) said they make extra effort to accrue participants from rural areas of SC. 3.1 . CT recruitment strategies Table 1 shows the current recruiting strategies most often used. PIs most often reported personally recruiting their patients, followed by recruitment from local doctors, the use 1 Percentages add up to more than 100% because respondents could identify with more than one role.
of patient databases, and printed materials, such as flyers or brochures. PIs rarely or never recruit through faith-based organizations or by using radio or television ads. How PIs perceived the importance of various recruiting strategies was also examined. As shown in Table 2, being open and honest with patients (M = 4.62) was seen as most important to the overall recruiting of patients into CTs, followed by making CT information and consent forms simple and short (M = 4.24), and providing flexible appointments for patients (M = 4.13). Recruiting strategies perceived as least important to general CT recruiting included communicating through printed materials, such as posters, pamphlets and church bulletins (M = 3.35), communicating through mass media (M = 3.35), and providing childcare during appointments (M = 3.24). As also illustrated in Table 2, with means with different superscripts differing significantly at p b .05, we examined how PIs perceived the importance of various recruiting strategies by population (i.e., importance of recruiting strategies in the general public versus barriers in rural or AA communities). Although 8 of the 13 recruiting strategies were seen as equally important across populations, there were other strategies (n = 5) that were thought to be significantly more important when recruiting rural and AA patients. Specifically, providing transportation (general public by rural: t(df = 84) = −3.089, p = .003, general public by AA: t(df = 76) = −4.352, p = .001), providing monetary incentives (general public by rural: t(df = 82) = −2.409, p = .018, general public by AA: t(df = 75) = −2.482, p = .015), communicating through printed materials (general public by rural: t(df = 84) = −4.456, p = .001, general public by AA: t(df = 76) = −4.442, p = .001), and providing childcare during appointments (general public by rural: t(df = 83) = −2.070, p = .042, general public by AA: t(df = 75) = −3.661, p = .001) were perceived as more important when recruiting rural and AA patients than when recruiting from the general public. Providing community outreach was seen as significantly more important when recruiting AAs than when recruiting from the general population (t(df = 75) = − 2.656, p = .01).
42
A. Tanner et al. / Contemporary Clinical Trials 41 (2015) 39–44
Table 2 Investigators' perceived importance of clinical trial recruitment strategies by population (general public, rural and African American). How important are the following strategies for clinical trial recruitment and participation (1 = Not at all important; 5 = Extremely important)
General public Mean
a. Be honest and open with patients. b. Make clinical trial information and consent form simple and short. c. Provide flexible scheduling of appointments. d. Make clinical trial information more accessible and available in a variety of forms (e.g., written, online, multimedia) and languages. e. Be aware of information overload and stresses faced by patients. f. Provide patients and general public with a list of clinical trials available at the hospital. g. Provide transportation.* h. Provide patient education and seminars. i. Provide monetary reimbursement and incentive for participation.* j. Provide community outreach and education (e.g. seminars for public).* k. Communicate through printed materials (posters, pamphlets, church bulletins, etc.).* l. Communicate through mass media (TV, radio, newspaper, etc.). m. Provide childcare.*
Rural residents SD
4.62 4.24 4.13 3.99
.680 .705 .792 .746
3.98 3.86 3.67a 3.66 3.64a 3.61a 3.41a 3.35 3.24a
.856 .914 1.00 .806 1.09 .908 .966 .959 1.02
Mean 4.52 4.33 4.20 4.07 3.96 3.89 3.93b 3.73 3.88b 3.72ac 3.78b 3.44 3.39b
African Americans
SD .666 .697 .780 .708 .808 .817 1.01 .864 1.01 .825 .891 .919 1.10
Mean 4.64 4.34 4.30 4.09 4.05 3.80 4.04b 3.83 3.86b 3.86bc 3.79b 3.38 3.55b
SD .605 .703 .796 .786 .776 .938 .910 .909 1.09 .928 .964 1.09 1.12
Note. Means with different superscripts differ significantly at p b .05. Means that share the same superscript are not significantly different. * Statistically significant findings.
4 . Discussion Effective communication of CT information has been identified as a critical need to assist individuals in making decisions about participating in CTs [27]. To our knowledge, this is the first formative study in the southeastern United States to describe the recruiting activities taking place at academic medical centers and to assess CT investigators' perceptions about the importance of various recruiting strategies. Consistent with other studies [1,28], investigators said that it was difficult, overall, to find patients to participate in CT research, but particularly difficult to find participants from rural areas. Unfortunately, it is often individuals from these underserved communities who lack access to health care and preventive services and who need the opportunity to obtain novel medical care provided through CTs. Study results also indicated that a majority of the CTs, which focus on the treatment of cancer and cardiovascular disease, corresponds with some of the largest health disparities in the state [29]. Without sufficient participation in CTs, development and evaluation of new therapies to treat these illnesses are delayed [3], and patients may not be accessing quality care. One key finding focused on the current recruiting practices of CT PIs. PIs at main academic medical centers are primarily recruiting through the use of traditional methods, including personal recruitment of patients, recruitment by local doctors, the use of patient databases, and through printed materials, such as brochures and flyers. Perhaps these methods, which typically are undertaken within the medical setting, are used because investigators are most familiar and comfortable with these recruiting tactics. These strategies, however, may not reach those in medically underserved communities who do not have a primary physician or access to a hospital. A recent study by Friedman and colleagues [28] reported that people in both urban and rural communities indicated a lack of patient– provider communication about CTs and limited trust in health care providers. In fact, recruiting methods that have been shown to enhance CT participation in hard-to-reach populations, such as through community-based organizations and through media
channels, [21] were the strategies least likely to be utilized by investigators who participated in our survey. For example, CT recruiting strategies were least likely to include community outreach through faith-based or community organizations or promotion through media, such as Internet, radio, and television. On the other hand, being honest with patients, making clinical trial information and consent forms simple and short, and being flexible when scheduling appointments were perceived as most important when communicating about CTs. These tactics, while important, focus on the one-on-one relationship between a CT investigator and a patient who is already aware of a particular CT. Findings concur with previous research suggesting that CT investigators rarely communicate about clinical research outside of specific, study-based recruitment messages, which are often only provided to current patients already familiar with the medical institution [30]. As lack of overall knowledge about CTs and misperceptions about clinical research are two of the primary factors influencing low CT participation [13], there is a real need for CT teams to develop communication strategies and participate in outreach that will make the public aware of and knowledgeable about CTs. Without dissemination of CT knowledge and awareness messages, there is a large, untapped pool of eligible CT participants who may only be exposed to information about CTs through fictional television medical dramas or negative reports about CTs in the news [30–32]. Another intriguing finding is that few strategies were seen as significantly more important when recruiting in rural or AA communities than in the general population. Specifically, methods to break down structural barriers to CT accrual were seen as more important methods to recruit from rural and AA populations. These tactics included providing transportation, providing monetary incentives, communicating through printed materials, and providing childcare during appointments [33]. While these incentives are important to study participation, the findings, again, stress PIs' focus on the health care provider/ patient relationship and not CT promotion or community partnerships to help increase awareness about CTs. This study has limitations. First, the participating PIs were recruited only from SC's five main academic medical centers.
A. Tanner et al. / Contemporary Clinical Trials 41 (2015) 39–44
This study did not include PIs who may be conducting CTs in major medical centers across the United States. Also, the focus on SC's main academic medical centers provided a relatively small pool of potential survey participants (N = 382 after nonworking emails were purged from our list). Second, our response rate was 31%, a rate that some would suggest is somewhat low. A 30% response rate, however, is fairly typical for survey research with busy physicians and other healthcare professionals [34]. Additionally, our total number of responses per question varied considerably since the survey was presented in an online format where participants could “skip” questions or “quit” the survey at any time. Predictably, questions asked later in the survey had higher item non-response rates. Finally, although we asked investigators about the type of trial, such as treatment or prevention, and the disease or condition being studied, we did not ask investigators about the type of intervention being examined (e.g., exercise, nutrition, or drug therapy). The authors recognize that the type of trial could impact the recruitment method that is most effective. Social marketing, defined as the application of commercial marketing techniques to influence the behavior of audiences [35] has been used to guide recruitment, marketing, and message development for health promotion and stresses the effectiveness of coupling tailored promotion and community partnership to increase knowledge and awareness of CTs [19,23,36]. Findings from the current study, however, show that CT teams rarely promote CT research outside of the medical setting or reach out to community organizations to serve as an important conduit between the medical institution and hard-to-reach populations. Although investigators rely heavily on local physicians to recruit patients into their studies, there may be limited communication between the investigators and local physicians [37] and between these local doctors and their patients [28]. As reported elsewhere [8], SC CT investigators are aware of the barriers to participation in specific communities, for example, distrust of CTs in the AA community and low literacy rates in rural and AA communities. Therefore, findings from the current study suggest that it is not investigators' lack of knowledge about CT barriers that hinders the CT communication process. Instead, investigators may have little understanding of how to tailor information in a manner in which it will be well-received by individuals in a particular community or how to disseminate the information through channels that are likely to reach these individuals. Results concur with previous research [10] maintaining that poor understanding of patients' perceptions about CTs often prevents investigators from incorporating strategies that will engage individuals in underserved communities. Future research should focus on determining how to communicate with CT teams about the importance of promotion and partnership when developing CT recruiting strategies. Next steps should also address increasing the communication and cooperation between CT investigators and local physicians who are often involved in the presentation, explanation, and enrollment of CT patients. Acknowledgments Research was funded by Health Sciences South Carolina. We are grateful to Dr. Jay Moskowitz and Dr. Amy Brock Martin for their support and assistance.
43
References [1] Felder TM, Pena GD, Chapital BF. Peer reviewed: disparities in cancer clinical trials: an analysis of comprehensive cancer control plans. Prev Chronic Dis 2009;6(4). [2] Weckstein DJ, Thomas CA, Emery IF, Shea BF, Fleury A, White ME, et al. Assessment of perceived cost to the patient and other barriers to clinical trial participation. J Oncol Pract 2011;7(5):330–3. [3] Embi PJ, Jain A, Clark J, Bizjack S, Hornung R, Harris CM. Effect of a clinical trial alert system on physician participation in trial recruitment. Arch Intern Med 2005;165(19). http://dx.doi.org/10.1001/archinte.165.19. 2272 [Epub 2005/10/26. PubMed PMID: 16246994; PubMed Central PMCID: PMC1343501]. [4] National Institutes of Health. Learn about clinical studies. [cited 2013 March 1]. Available from: http://clinicaltrials.gov/ct2/info/understand; 2012. [5] National Institutes of Health. NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research—amended. [cited 2013 March 1]. Available from: http://grants.nih.gov/grants/funding/ women_min/guidelines_amended_10_2001.htm; October 2001. [6] Ford JG, Howerton MW, Bolen S, Gary TL, Lai GY, Tilburt J, et al. Knowledge and access to information on recruitment of underrepresented populations to cancer clinical trials. Evid Rep Technol Assess (Summ) 2005(122): 1–11 [Epub 2005/07/02. PubMed PMID: 15989377]. [7] Heller C, Balls-Berry JE, Nery JD, Erwin PJ, Littleton D, Kim M, et al. Strategies addressing barriers to clinical trial enrollment of underrepresented populations: a systematic review. Contemp Clin Trials 2014. http:// dx.doi.org/10.1016/j.cct.2014.08.004 [Epub 2014/08/19. PubMed PMID: 25131812]. [8] Tanner A, Kim SH, Friedman DB, Foster C, Bergeron CD. Barriers to medical research participation as perceived by clinical trial investigators: communicating with rural and African American communities. J Health Commun 2014:1–9. http://dx.doi.org/10.1080/10810730.2014.908985 [Epub 2014/ 09/11. PubMed PMID: 25204763]. [9] Mendoza DB, Williams MT, Chapman LK, Powers M. Minority inclusion in randomized clinical trials of panic disorder. J Anxiety Disord 2012;26(5): 574–82. http://dx.doi.org/10.1016/j.janxdis.2012.02.011 [Epub 2012/03/ 27. PubMed PMID: 22445317]. [10] Vesey GA. A successful strategy for recruitment and retention of Black Elders in applied research. Afr Am Res Perspect 2002;8(2):40–56. [11] Williams MT, Beckmann-Mendez DA, Turkheimer E. Cultural barriers to African American participation in anxiety disorders research. J Natl Med Assoc 2013;105(1):33–41 [Epub 2013/07/19. PubMed PMID: 23862294; PubMed Central PMCID: PMC4161612]. [12] Williams MT, Proetto D, Casiano D, Franklin ME. Recruitment of a hidden population: African Americans with obsessive–compulsive disorder. Contemp Clin Trials 2012;33(1):67–75. http://dx.doi.org/10.1016/j.cct. 2011.09.001 [Epub 2011/10/11. PubMed PMID: 21983626; PubMed Central PMCID: PMC3253913]. [13] Quinn GP, Bell BA, Bell MY, Caraway VD, Conforte D, Graci LB, et al. The guinea pig syndrome: improving clinical trial participation among thoracic patients. J Thorac Oncol 2007;2:191–6. [14] Guadagnolo BA, Petereit DG, Helbig P, Koop D, Kussman P, Dunn EF, et al. Involving American Indians and medically underserved rural populations in cancer clinical trials. Clin Trials 2009;6:610–7. [15] Branson RD, Davis Jr K, Butler KL. African Americans' participation in clinical research: importance, barriers, and solutions. Am J Surg 2007; 193(1):32–9. http://dx.doi.org/10.1016/j.amjsurg.2005.11.007 [discussion 40. Epub 2006/12/26. S0002-9610(05)00873-1 [pii] PubMed PMID: 17188084]. [16] McComas KA, Yang Z, Gay GK, Leonard JP, Dannenberg AJ, Dillon H. Individuals' willingness to talk to their doctors about clinical trial enrollment. J Health Commun 2010;15(2):189–204. http://dx.doi. org/10.1080/10810730903528058 [Epub 2010/04/15. PubMed PMID: 20390986]. [17] Castel P, Negrier S, Boissel JP. Why don't cancer patients enter clinical trials? A review. Eur J Cancer 2006;42(12):1744–8. http://dx.doi.org/10. 1016/j.ejca.2005.10.033 [Epub 2006/06/17. PubMed PMID: 16777404]. [18] Ford LG, Minasian LM, McCaskill Stevens W, Pisano ED, Sullivan D, Smith RA. Prevention and early detection clinical trials: opportunities for primary careproviders and their patients. CA Cancer J Clin 2009;53(2): 82–101. [19] Friedman DB, Hooker SP, Wilcox S, Burroughs EL, Rheaume CE. African American men's perspectives on promoting physical activity: “we're not that difficult to figure out!”. J Health Commun 2012. http://dx.doi.org/10. 1080/10810730.2012.665424 [online first]. [20] Friedman DB, Kim SH, Tanner A, Bergeron CD, Foster C, General K. How are we communicating about clinical trials?: an assessment of the content and readability of recruitment resources. Contemp Clin Trials 2014;38(2):
44
[21]
[22]
[23]
[24] [25] [26] [27]
[28]
[29]
A. Tanner et al. / Contemporary Clinical Trials 41 (2015) 39–44 275–83. http://dx.doi.org/10.1016/j.cct.2014.05.004 [Epub 2014/05/20. PubMed PMID: 24836075]. Mackenzie IS, Wei L, Rutherford D, Findlay EA, Saywood W, Campbell MK, et al. Promoting public awareness of randomised clinical trials using the media: the ‘Get Randomised’ campaign. Br J Clin Pharmacol 2010;69(2): 128–35. http://dx.doi.org/10.1111/j.1365-2125.2009.03561.x [Epub 2010/ 03/18. PubMed PMID: 20233175; PubMed Central PMCID: PMC2817445]. Lai GY, Gary TL, Tilburt J, Bolen S, Baffi C, Wilson RF, et al. Effectiveness of strategies to recruit underrepresented populations into cancer clinical trials. Clin Trials 2006;3(2):133–41 [Epub 2006/06/16. PubMed PMID: 16773955]. Nichols L, Martindale-Adams J, Burns R, Coon D, Ory M, Mahoney D, et al. Social marketing as a framework for recruitment: illustrations from the REACH study. J Aging Health 2004;16(5 Suppl.):157S–76S. http://dx.doi. org/10.1177/0898264304269727 [Epub 2004/09/28. PubMed PMID: 15448292; PubMed Central PMCID: PMC2579268]. U.S. Census Bureau. 2010. U.S. Census Bureau. South Carolina State & County Quick Facts; 2012. SC Rural Health Research Center. State rural plan for South Carolina. SC Rural Health Research Center; 2008. Wells KJ, Quinn GP, Meade CD, Fletcher M, Tyson DM, Jim H, et al. Development of a cancer clinical trials multi-media intervention: clinical trials: are they right for you? Patient Educ Couns 2012;88(2):232–40. http://dx.doi.org/10.1016/j.pec.2012.03.011 [Epub 2012/04/25. PubMed PMID: 22525803]. Friedman DB, Bergeron CD, Foster C, Tanner A, Kim SH. What do people really know and think about clinical trials? A comparison of rural and urban communities in the South. J Community Health 2013;38(4): 642–51. http://dx.doi.org/10.1007/s10900-013-9659-z Epub 2013/03/08. PubMed PMID: 23468319. The burden of heart disease and stroke in South Carolina. Columbia, SC: South Carolina Department of Health and Environmental Control: Heart Disease and Stroke Prevention Division; 2010.
[30] Getz KA. Restoring public confidence in clinical research: Lessons from the organ donation sector. The Monitor [Internet]. 2008 March 5, 2013; (September): [59–62 pp.]. Available from: http://216.147.199.31/Monitor/2008September/Getz2.pdf. [31] Len-Rios ME, Qiu Q. Negative articles predict clinical trial reluctance. Newsp Res J 2007;28:24–39. [32] Bergeron C, Foster C, Friedman DB, Tanner A, Kim S-H. Clinical trial recruitment in rural South Carolina: a comparison of investigators' perceptions and potential participant eligibility. Rural Remote Health 2013;13(4):2567. [33] Coleman-Phox K, Laraia BA, Adler N, Vieten C, Thomas M, Epel E. Peer reviewed: recruitment and retention of pregnant women for a behavioral intervention: lessons from the Maternal Adiposity, Metabolism, and Stress (MAMAS) study. Prev Chronic Dis 2013;10. [34] Bonevski B, Magin P, Horton G, Foster M, Girgis A. Response rates in GP surveys: trialing two recruitment strategies. Aust Fam Physician 2011; 40(6):1. [35] Andreason A. Marketing social change: changing behavior to promote health, social development, and the environment. San Francisco: JosseyBass; 1995. [36] Friedman DB, Corwin SJ, Dominick GM, Rose ID. African American men's understanding and perceptions about prostate cancer: why multiple dimensions of health literacy are important in cancer communication. J Community Health 2009;34(5):449–60. http://dx.doi.org/10.1007/ s10900-009-9167-3 [Epub 2009/06/12. PubMed PMID: 19517223]. [37] Comis RL, Crowley J, Unger J, Marinucci D, Catalano R, Colaizzi D, et al. Baseline study of patient accrual onto publicly sponsored U.S. cancer clinical trials: an analysis conducted for the global access project of the National Patient Advocate Foundation. Philadelphia, PA: Coalition of Cancer Cooperative Groups; 2006[April 21, 2009. Available from: http:// www.npaf.org/images/pdf/gap/sept_2006/cccg.pdf].
Contents lists available at ScienceDirect
Contemporary Clinical Trials journal homepage: www.elsevier.com/locate/conclintrial
Promoting clinical research to medically underserved communities: Current practices and perceptions about clinical trial recruiting strategies Andrea Tanner a,⁎, Sei-Hill Kim a, Daniela B. Friedman b,c, Caroline Foster d, Caroline D. Bergeron b a
School of Journalism and Mass Communications, University of South Carolina, Columbia, SC, United States Department of Health Promotion, Education, and Behavior, University of South Carolina, Columbia, SC, United States c Statewide Cancer Prevention and Control Program, University of South Carolina, Columbia, SC, United States d College of Charleston, Charleston, SC, United States b
a r t i c l e
i n f o
Article history: Received 29 September 2014 Received in revised form 15 December 2014 Accepted 16 December 2014 Available online 23 December 2014 Keywords: Health promotion Clinical trial Recruitment Research participation
a b s t r a c t Introduction: Although clinical trials have the potential to provide the most advanced medical treatments and screening options, accrual rates remain low among medically underserved populations. Strategies to enhance clinical trial recruitment are frequently undertaken without developing, implementing, and evaluating communication and educational activities. This study assesses the current clinical trial recruiting efforts taking place at academic medical centers in a southeastern state and explores principal investigators' attitudes and beliefs about how to successfully recruit for clinical trials, in the general population, and in African American and rural communities. Methods: An online survey was used to collect responses from clinical trial principal investigators working in a southeastern state's five main academic medical centers. Respondents were asked about their experience with recruitment and recruiting strategies, in general, and in the African American and rural communities. Results: Respondents said that it was most difficult to find rural residents to participate in clinical trials (M = 3.60, SD = .93), followed by the general public (M = 3.30, SD = .99) and African American residents (M = 3.15, SD = .99). Investigators most often reported personally recruiting their patients (M = 3.50, SD = 1.34) and through local doctors (M = 2.80, SD = 1.20). Principal investigators rarely recruit through faith-based organizations (M = 1.74, SD = 1.05), or by using radio (M = 1.62, SD = .90), or television ads (M = 1.42, SD = .75). Conclusion: Clinical trial investigators rarely communicate about clinical research outside of the medical setting or partner with community organizations or local doctors to reach individuals in medically underserved communities. Study implications describe the importance of educating research teams about how best to promote clinical trial awareness and knowledge. © 2014 Published by Elsevier Inc.
1 . Introduction Clinical trials (CTs) are essential to the advancement of public health and medical research in the areas of prevention, ⁎ Corresponding author at: School of Journalism and Mass Communications, Carolina Coliseum, Office 4011C, University of South Carolina, Columbia SC, 29201, United States. Tel.: +803 777 6827. E-mail address: [email protected] (A. Tanner).
http://dx.doi.org/10.1016/j.cct.2014.12.010 1551-7144/© 2014 Published by Elsevier Inc.
diagnosis, screening, treatment and quality of life, yet recruitment of patients into CTs continues to be an enormous challenge [1]. Failure to meet CT recruitment goals is common [2]. Such recruitment failures often jeopardize the quality of a study, delay the development and evaluation of new therapies, and can lead to an increase in costs to the health care system [3]. Despite the lack of participation, CT research continues to be a priority for academic medical centers and research funding agencies [3] and is considered the gold standard for evaluating
40
A. Tanner et al. / Contemporary Clinical Trials 41 (2015) 39–44
the effectiveness of treatment or preventive procedures on humans [4]. Although it has been nearly 20 years since the NIH established guidelines for the inclusion of women and minorities in clinical research [5], current accrual rates into CTs are low among minority and other medically underserved populations, including African American (AA) and rural residents regardless of disease, type of trial, or sponsoring agency [1,6–12]. The barriers to CT participation have been studied extensively, with these barriers primarily falling into two categories: patient- and physician-related barriers. Patient-related barriers include cognitive barriers, such as lack of awareness or understanding about CTs [13], structural barriers, which include concerns about participation costs, travel and insurance coverage [14], and psychological barriers, including misperceptions, distrust, and fear [15]. Physician-related barriers include limited knowledge of ongoing CTs, unsupportive attitudes, and a lack of motivation to enroll patients [16,17]. Traditional strategies to recruit participants into CTs include posting flyers and sending recruitment letters to local physicians [3,18–20]. Other methods used to enhance trial participation, particularly in underrepresented populations, include the use of clinical registries and electronic health records [3], recruitment through community organizations, and use of media and educational outreach [21]. Few studies have evaluated the effectiveness of CT recruiting strategies [22]. Strategies to enhance CT recruitment are frequently undertaken without a comprehensive plan to develop, implement, and evaluate communication and educational activities [23] and there is a need for additional research focusing on CT recruitment strategies. The purpose of this study is to evaluate how CT principal investigators (PIs) utilize various CT recruiting strategies to enroll patients. No studies, to our knowledge, have explored the communication and recruitment strategies of CT PIs at academic medical centers and their perceptions of the importance of specific recruiting tactics. The objectives of this study were to 1) describe the current recruiting efforts at academic medical centers in a southeastern state and 2) explore PIs' attitudes and beliefs about how to successfully recruit for CTs, in the general population and in AA and rural communities. The authors' long-term goal is to incorporate this important formative research into the development of a comprehensive communication and educational plan to increase enrollment in a wide array of CTs. 2 . Methods 2.1 . Study participants and design This research consisted of an online survey of CT PIs working in a southeastern state's five main academic medical centers. These medical centers are all affiliates of a statewide biomedical research collaborative committed to transforming South Carolina's (SC) public health and economic well-being through research (http://www.healthsciencessc.org). According to the U.S. Census Bureau [25], SC is a state with a sizeable African American (AA) population (e.g., 28.0% of the SC population is AA versus 13.1% nationally) that is also largely rural (e.g., 25 of SC's 46 counties are designated as nonmetropolitan (i.e., rural) with 39.5% of the state's population living in rural areas, compared to 21.0% nationally) [26]. All but one of the medical centers were located in three largest cities in
SC, and all were within close proximity of rural areas of the state [24]. We first developed a sampling frame, as efforts to locate contact information for CT PIs working in these academic medical centers revealed no such resource. The clinicaltrials.gov website, which provides information about federally and privately supported CTs, includes contact information for trial sponsors, but not for CT investigators. We searched hospital websites and contacted institutions' research offices to ask for PIs' names and email addresses. These efforts resulted in an attempted census of CT PIs from the five academic medical centers in the state. To complete the sampling frame, we distributed our online questionnaire via email sent from the hospitals' Institutional Review Board (IRB) directors to the hospitals' PIs. Our sampling frame included the names and email addresses of 417 PIs. In June and July 2011, an email was sent to each PI requesting his or her participation in a web-based survey, which included a link to the questionnaire. Three follow-up emails were sent to increase the response rate. After nonworking email addresses were purged from the list (n = 35), the revised sample frame included 382 PIs. Ultimately, 119 (31% of working addresses) respondents completed the online questionnaire. Where the reported sample is less than 119, it indicates that not all respondents answered all the questions. In most cases this was because it was not relevant to the respondent and the online survey software automatically omitted the question, but in other cases, the respondent may have forgotten to answer or chosen not to answer. The survey was administered using the online survey tool Qualtrics, a subscription-based survey site (Qualtrics.com). The IRB at the authors' university approved the survey instrument. 2.2 . Study variables Respondents were asked how difficult it is to find people, ingeneral, and from rural areas and AA communities to participate in their own CT research (five-point scale ranging from “very difficult” to “very easy”). Respondents were also asked if they make extra effort to recruit from rural areas and AA communities in SC. We also asked about the recruiting strategies the PIs employ to recruit CT participants. Using a five-point Likert scale ranging from “never” to “always,” respondents were asked how often they use recruiting strategies involving traditional methods of recruiting, including patient databases and personal recruitment by the PIs. They were also asked about their use of community partnerships to recruit participants. These items included recruiting through community organizations, such as the YMCA, community health organizations, faith-based organizations, local doctors, or social services or work organizations. How often they used different promotional strategies, including printed materials, such as flyers, brochures, and posters, and advertisements in various media outlets was also assessed. A battery of questions ascertained CT investigators' perceptions of the importance of different CT recruitment strategies, in general, and in the AA and rural communities. Respondents were asked to rate their level of importance from “not at all important” to “extremely important” on a five-point scale with 13 possible strategies for recruitment, including make CT information more accessible and available in a variety of forms
A. Tanner et al. / Contemporary Clinical Trials 41 (2015) 39–44
and languages, make information and consent forms simple and short, provide patients and general public with a list of CTs available at the hospital, provide patient education and seminars, provide community outreach and education, communicate through printed materials (posters, pamphlets, church bulletins, etc.), communicate through mass media (TV, radio, newspaper, etc.), be aware of information overload and stresses faced by patients, be honest and open with patients, provide monetary reimbursement or incentive for participation, provide transportation, provide childcare, and provide flexible scheduling of appointments. The literature on CT recruitment strategies was used to develop these questions [18,21,22]. Several demographic and contextual variables were also assessed. PIs were asked about their credentials, years of CT experience, the focus of trials conducted, including prevention, screening, diagnosis, treatment, quality of life and expanded access, and specific type of CT such as cancer, diabetes, reproductive health and mental health.
41
Table 1 Current Recruiting Strategies of Clinical Trial Investigators at SC Academic Medical Centers. How often do you recruit potential patients through: (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; 5 = Always) 1. Personal recruitment by investigators 2. Local doctors 3. Patient databases 4. Printed materials (e.g., flyers, brochures, posters) 5. Print ads (e.g., newspapers, magazines) 6. Community organizations 7. Community health organizations (e.g., rural health clinics) 8. Social services/work organizations 9. Internet 10. Federally qualified health centers 11. Faith-based organizations 12. Radio ads 13. TV ads
Mean
SD
3.50 2.80 2.64 2.58 2.03 2.01 1.85
1.34 1.20 1.32 1.36 1.15 1.15 1.03
1.84 1.82 1.75 1.74 1.62 1.42
1.04 1.07 .98 1.05 .90 .75
2.3 . Data analysis Descriptive statistics, frequencies, and paired sample t-tests were generated. All statistical analyses were conducted with SPSS Version 18. 3 . Results Eighty-three percent (n = 99) of respondents self-identified as a PI, a CT manager, project manager or recruiter (12%, n = 15), research associate (4%, n = 5), nurse (3%, n = 3) or “other” (4%, n = 5).1 Years of experience working with CTs ranged from 1 to 40 years, with a mean of 11.3 years. Cancer (n = 66) was most often identified as the specific disease or condition being studied, followed by reproductive health issues (n = 32), cardiovascular disorders (n = 30) and diabetes (n = 20). The most common focus of research was treatment of illness or disease with nearly three-quarters (71%, n = 85) of respondents indicating that they conducted at least one trial focusing on treatment in the past two years. This was followed by prevention (34%, n = 41), quality of life (31%, n = 37) and diagnosis (29%, n = 33). Respondents (n = 93/119) agreed that it was most difficult to find rural residents to participate in CTs (M = 3.60, SD = .93), followed by the general public (M = 3.30, SD = .99) and AA residents (M = 3.15, SD = .99). Significant differences were found between the perceived difficulty in finding rural residents as related to participants from AA communities (t(df = 83) = 4.255 p = .01) and the general public (t(df = 86) = 2.985 p = .01). Few respondents (36%, n = 33/93) said they make extra effort to accrue participants from rural areas of SC. 3.1 . CT recruitment strategies Table 1 shows the current recruiting strategies most often used. PIs most often reported personally recruiting their patients, followed by recruitment from local doctors, the use 1 Percentages add up to more than 100% because respondents could identify with more than one role.
of patient databases, and printed materials, such as flyers or brochures. PIs rarely or never recruit through faith-based organizations or by using radio or television ads. How PIs perceived the importance of various recruiting strategies was also examined. As shown in Table 2, being open and honest with patients (M = 4.62) was seen as most important to the overall recruiting of patients into CTs, followed by making CT information and consent forms simple and short (M = 4.24), and providing flexible appointments for patients (M = 4.13). Recruiting strategies perceived as least important to general CT recruiting included communicating through printed materials, such as posters, pamphlets and church bulletins (M = 3.35), communicating through mass media (M = 3.35), and providing childcare during appointments (M = 3.24). As also illustrated in Table 2, with means with different superscripts differing significantly at p b .05, we examined how PIs perceived the importance of various recruiting strategies by population (i.e., importance of recruiting strategies in the general public versus barriers in rural or AA communities). Although 8 of the 13 recruiting strategies were seen as equally important across populations, there were other strategies (n = 5) that were thought to be significantly more important when recruiting rural and AA patients. Specifically, providing transportation (general public by rural: t(df = 84) = −3.089, p = .003, general public by AA: t(df = 76) = −4.352, p = .001), providing monetary incentives (general public by rural: t(df = 82) = −2.409, p = .018, general public by AA: t(df = 75) = −2.482, p = .015), communicating through printed materials (general public by rural: t(df = 84) = −4.456, p = .001, general public by AA: t(df = 76) = −4.442, p = .001), and providing childcare during appointments (general public by rural: t(df = 83) = −2.070, p = .042, general public by AA: t(df = 75) = −3.661, p = .001) were perceived as more important when recruiting rural and AA patients than when recruiting from the general public. Providing community outreach was seen as significantly more important when recruiting AAs than when recruiting from the general population (t(df = 75) = − 2.656, p = .01).
42
A. Tanner et al. / Contemporary Clinical Trials 41 (2015) 39–44
Table 2 Investigators' perceived importance of clinical trial recruitment strategies by population (general public, rural and African American). How important are the following strategies for clinical trial recruitment and participation (1 = Not at all important; 5 = Extremely important)
General public Mean
a. Be honest and open with patients. b. Make clinical trial information and consent form simple and short. c. Provide flexible scheduling of appointments. d. Make clinical trial information more accessible and available in a variety of forms (e.g., written, online, multimedia) and languages. e. Be aware of information overload and stresses faced by patients. f. Provide patients and general public with a list of clinical trials available at the hospital. g. Provide transportation.* h. Provide patient education and seminars. i. Provide monetary reimbursement and incentive for participation.* j. Provide community outreach and education (e.g. seminars for public).* k. Communicate through printed materials (posters, pamphlets, church bulletins, etc.).* l. Communicate through mass media (TV, radio, newspaper, etc.). m. Provide childcare.*
Rural residents SD
4.62 4.24 4.13 3.99
.680 .705 .792 .746
3.98 3.86 3.67a 3.66 3.64a 3.61a 3.41a 3.35 3.24a
.856 .914 1.00 .806 1.09 .908 .966 .959 1.02
Mean 4.52 4.33 4.20 4.07 3.96 3.89 3.93b 3.73 3.88b 3.72ac 3.78b 3.44 3.39b
African Americans
SD .666 .697 .780 .708 .808 .817 1.01 .864 1.01 .825 .891 .919 1.10
Mean 4.64 4.34 4.30 4.09 4.05 3.80 4.04b 3.83 3.86b 3.86bc 3.79b 3.38 3.55b
SD .605 .703 .796 .786 .776 .938 .910 .909 1.09 .928 .964 1.09 1.12
Note. Means with different superscripts differ significantly at p b .05. Means that share the same superscript are not significantly different. * Statistically significant findings.
4 . Discussion Effective communication of CT information has been identified as a critical need to assist individuals in making decisions about participating in CTs [27]. To our knowledge, this is the first formative study in the southeastern United States to describe the recruiting activities taking place at academic medical centers and to assess CT investigators' perceptions about the importance of various recruiting strategies. Consistent with other studies [1,28], investigators said that it was difficult, overall, to find patients to participate in CT research, but particularly difficult to find participants from rural areas. Unfortunately, it is often individuals from these underserved communities who lack access to health care and preventive services and who need the opportunity to obtain novel medical care provided through CTs. Study results also indicated that a majority of the CTs, which focus on the treatment of cancer and cardiovascular disease, corresponds with some of the largest health disparities in the state [29]. Without sufficient participation in CTs, development and evaluation of new therapies to treat these illnesses are delayed [3], and patients may not be accessing quality care. One key finding focused on the current recruiting practices of CT PIs. PIs at main academic medical centers are primarily recruiting through the use of traditional methods, including personal recruitment of patients, recruitment by local doctors, the use of patient databases, and through printed materials, such as brochures and flyers. Perhaps these methods, which typically are undertaken within the medical setting, are used because investigators are most familiar and comfortable with these recruiting tactics. These strategies, however, may not reach those in medically underserved communities who do not have a primary physician or access to a hospital. A recent study by Friedman and colleagues [28] reported that people in both urban and rural communities indicated a lack of patient– provider communication about CTs and limited trust in health care providers. In fact, recruiting methods that have been shown to enhance CT participation in hard-to-reach populations, such as through community-based organizations and through media
channels, [21] were the strategies least likely to be utilized by investigators who participated in our survey. For example, CT recruiting strategies were least likely to include community outreach through faith-based or community organizations or promotion through media, such as Internet, radio, and television. On the other hand, being honest with patients, making clinical trial information and consent forms simple and short, and being flexible when scheduling appointments were perceived as most important when communicating about CTs. These tactics, while important, focus on the one-on-one relationship between a CT investigator and a patient who is already aware of a particular CT. Findings concur with previous research suggesting that CT investigators rarely communicate about clinical research outside of specific, study-based recruitment messages, which are often only provided to current patients already familiar with the medical institution [30]. As lack of overall knowledge about CTs and misperceptions about clinical research are two of the primary factors influencing low CT participation [13], there is a real need for CT teams to develop communication strategies and participate in outreach that will make the public aware of and knowledgeable about CTs. Without dissemination of CT knowledge and awareness messages, there is a large, untapped pool of eligible CT participants who may only be exposed to information about CTs through fictional television medical dramas or negative reports about CTs in the news [30–32]. Another intriguing finding is that few strategies were seen as significantly more important when recruiting in rural or AA communities than in the general population. Specifically, methods to break down structural barriers to CT accrual were seen as more important methods to recruit from rural and AA populations. These tactics included providing transportation, providing monetary incentives, communicating through printed materials, and providing childcare during appointments [33]. While these incentives are important to study participation, the findings, again, stress PIs' focus on the health care provider/ patient relationship and not CT promotion or community partnerships to help increase awareness about CTs. This study has limitations. First, the participating PIs were recruited only from SC's five main academic medical centers.
A. Tanner et al. / Contemporary Clinical Trials 41 (2015) 39–44
This study did not include PIs who may be conducting CTs in major medical centers across the United States. Also, the focus on SC's main academic medical centers provided a relatively small pool of potential survey participants (N = 382 after nonworking emails were purged from our list). Second, our response rate was 31%, a rate that some would suggest is somewhat low. A 30% response rate, however, is fairly typical for survey research with busy physicians and other healthcare professionals [34]. Additionally, our total number of responses per question varied considerably since the survey was presented in an online format where participants could “skip” questions or “quit” the survey at any time. Predictably, questions asked later in the survey had higher item non-response rates. Finally, although we asked investigators about the type of trial, such as treatment or prevention, and the disease or condition being studied, we did not ask investigators about the type of intervention being examined (e.g., exercise, nutrition, or drug therapy). The authors recognize that the type of trial could impact the recruitment method that is most effective. Social marketing, defined as the application of commercial marketing techniques to influence the behavior of audiences [35] has been used to guide recruitment, marketing, and message development for health promotion and stresses the effectiveness of coupling tailored promotion and community partnership to increase knowledge and awareness of CTs [19,23,36]. Findings from the current study, however, show that CT teams rarely promote CT research outside of the medical setting or reach out to community organizations to serve as an important conduit between the medical institution and hard-to-reach populations. Although investigators rely heavily on local physicians to recruit patients into their studies, there may be limited communication between the investigators and local physicians [37] and between these local doctors and their patients [28]. As reported elsewhere [8], SC CT investigators are aware of the barriers to participation in specific communities, for example, distrust of CTs in the AA community and low literacy rates in rural and AA communities. Therefore, findings from the current study suggest that it is not investigators' lack of knowledge about CT barriers that hinders the CT communication process. Instead, investigators may have little understanding of how to tailor information in a manner in which it will be well-received by individuals in a particular community or how to disseminate the information through channels that are likely to reach these individuals. Results concur with previous research [10] maintaining that poor understanding of patients' perceptions about CTs often prevents investigators from incorporating strategies that will engage individuals in underserved communities. Future research should focus on determining how to communicate with CT teams about the importance of promotion and partnership when developing CT recruiting strategies. Next steps should also address increasing the communication and cooperation between CT investigators and local physicians who are often involved in the presentation, explanation, and enrollment of CT patients. Acknowledgments Research was funded by Health Sciences South Carolina. We are grateful to Dr. Jay Moskowitz and Dr. Amy Brock Martin for their support and assistance.
43
References [1] Felder TM, Pena GD, Chapital BF. Peer reviewed: disparities in cancer clinical trials: an analysis of comprehensive cancer control plans. Prev Chronic Dis 2009;6(4). [2] Weckstein DJ, Thomas CA, Emery IF, Shea BF, Fleury A, White ME, et al. Assessment of perceived cost to the patient and other barriers to clinical trial participation. J Oncol Pract 2011;7(5):330–3. [3] Embi PJ, Jain A, Clark J, Bizjack S, Hornung R, Harris CM. Effect of a clinical trial alert system on physician participation in trial recruitment. Arch Intern Med 2005;165(19). http://dx.doi.org/10.1001/archinte.165.19. 2272 [Epub 2005/10/26. PubMed PMID: 16246994; PubMed Central PMCID: PMC1343501]. [4] National Institutes of Health. Learn about clinical studies. [cited 2013 March 1]. Available from: http://clinicaltrials.gov/ct2/info/understand; 2012. [5] National Institutes of Health. NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research—amended. [cited 2013 March 1]. Available from: http://grants.nih.gov/grants/funding/ women_min/guidelines_amended_10_2001.htm; October 2001. [6] Ford JG, Howerton MW, Bolen S, Gary TL, Lai GY, Tilburt J, et al. Knowledge and access to information on recruitment of underrepresented populations to cancer clinical trials. Evid Rep Technol Assess (Summ) 2005(122): 1–11 [Epub 2005/07/02. PubMed PMID: 15989377]. [7] Heller C, Balls-Berry JE, Nery JD, Erwin PJ, Littleton D, Kim M, et al. Strategies addressing barriers to clinical trial enrollment of underrepresented populations: a systematic review. Contemp Clin Trials 2014. http:// dx.doi.org/10.1016/j.cct.2014.08.004 [Epub 2014/08/19. PubMed PMID: 25131812]. [8] Tanner A, Kim SH, Friedman DB, Foster C, Bergeron CD. Barriers to medical research participation as perceived by clinical trial investigators: communicating with rural and African American communities. J Health Commun 2014:1–9. http://dx.doi.org/10.1080/10810730.2014.908985 [Epub 2014/ 09/11. PubMed PMID: 25204763]. [9] Mendoza DB, Williams MT, Chapman LK, Powers M. Minority inclusion in randomized clinical trials of panic disorder. J Anxiety Disord 2012;26(5): 574–82. http://dx.doi.org/10.1016/j.janxdis.2012.02.011 [Epub 2012/03/ 27. PubMed PMID: 22445317]. [10] Vesey GA. A successful strategy for recruitment and retention of Black Elders in applied research. Afr Am Res Perspect 2002;8(2):40–56. [11] Williams MT, Beckmann-Mendez DA, Turkheimer E. Cultural barriers to African American participation in anxiety disorders research. J Natl Med Assoc 2013;105(1):33–41 [Epub 2013/07/19. PubMed PMID: 23862294; PubMed Central PMCID: PMC4161612]. [12] Williams MT, Proetto D, Casiano D, Franklin ME. Recruitment of a hidden population: African Americans with obsessive–compulsive disorder. Contemp Clin Trials 2012;33(1):67–75. http://dx.doi.org/10.1016/j.cct. 2011.09.001 [Epub 2011/10/11. PubMed PMID: 21983626; PubMed Central PMCID: PMC3253913]. [13] Quinn GP, Bell BA, Bell MY, Caraway VD, Conforte D, Graci LB, et al. The guinea pig syndrome: improving clinical trial participation among thoracic patients. J Thorac Oncol 2007;2:191–6. [14] Guadagnolo BA, Petereit DG, Helbig P, Koop D, Kussman P, Dunn EF, et al. Involving American Indians and medically underserved rural populations in cancer clinical trials. Clin Trials 2009;6:610–7. [15] Branson RD, Davis Jr K, Butler KL. African Americans' participation in clinical research: importance, barriers, and solutions. Am J Surg 2007; 193(1):32–9. http://dx.doi.org/10.1016/j.amjsurg.2005.11.007 [discussion 40. Epub 2006/12/26. S0002-9610(05)00873-1 [pii] PubMed PMID: 17188084]. [16] McComas KA, Yang Z, Gay GK, Leonard JP, Dannenberg AJ, Dillon H. Individuals' willingness to talk to their doctors about clinical trial enrollment. J Health Commun 2010;15(2):189–204. http://dx.doi. org/10.1080/10810730903528058 [Epub 2010/04/15. PubMed PMID: 20390986]. [17] Castel P, Negrier S, Boissel JP. Why don't cancer patients enter clinical trials? A review. Eur J Cancer 2006;42(12):1744–8. http://dx.doi.org/10. 1016/j.ejca.2005.10.033 [Epub 2006/06/17. PubMed PMID: 16777404]. [18] Ford LG, Minasian LM, McCaskill Stevens W, Pisano ED, Sullivan D, Smith RA. Prevention and early detection clinical trials: opportunities for primary careproviders and their patients. CA Cancer J Clin 2009;53(2): 82–101. [19] Friedman DB, Hooker SP, Wilcox S, Burroughs EL, Rheaume CE. African American men's perspectives on promoting physical activity: “we're not that difficult to figure out!”. J Health Commun 2012. http://dx.doi.org/10. 1080/10810730.2012.665424 [online first]. [20] Friedman DB, Kim SH, Tanner A, Bergeron CD, Foster C, General K. How are we communicating about clinical trials?: an assessment of the content and readability of recruitment resources. Contemp Clin Trials 2014;38(2):
44
[21]
[22]
[23]
[24] [25] [26] [27]
[28]
[29]
A. Tanner et al. / Contemporary Clinical Trials 41 (2015) 39–44 275–83. http://dx.doi.org/10.1016/j.cct.2014.05.004 [Epub 2014/05/20. PubMed PMID: 24836075]. Mackenzie IS, Wei L, Rutherford D, Findlay EA, Saywood W, Campbell MK, et al. Promoting public awareness of randomised clinical trials using the media: the ‘Get Randomised’ campaign. Br J Clin Pharmacol 2010;69(2): 128–35. http://dx.doi.org/10.1111/j.1365-2125.2009.03561.x [Epub 2010/ 03/18. PubMed PMID: 20233175; PubMed Central PMCID: PMC2817445]. Lai GY, Gary TL, Tilburt J, Bolen S, Baffi C, Wilson RF, et al. Effectiveness of strategies to recruit underrepresented populations into cancer clinical trials. Clin Trials 2006;3(2):133–41 [Epub 2006/06/16. PubMed PMID: 16773955]. Nichols L, Martindale-Adams J, Burns R, Coon D, Ory M, Mahoney D, et al. Social marketing as a framework for recruitment: illustrations from the REACH study. J Aging Health 2004;16(5 Suppl.):157S–76S. http://dx.doi. org/10.1177/0898264304269727 [Epub 2004/09/28. PubMed PMID: 15448292; PubMed Central PMCID: PMC2579268]. U.S. Census Bureau. 2010. U.S. Census Bureau. South Carolina State & County Quick Facts; 2012. SC Rural Health Research Center. State rural plan for South Carolina. SC Rural Health Research Center; 2008. Wells KJ, Quinn GP, Meade CD, Fletcher M, Tyson DM, Jim H, et al. Development of a cancer clinical trials multi-media intervention: clinical trials: are they right for you? Patient Educ Couns 2012;88(2):232–40. http://dx.doi.org/10.1016/j.pec.2012.03.011 [Epub 2012/04/25. PubMed PMID: 22525803]. Friedman DB, Bergeron CD, Foster C, Tanner A, Kim SH. What do people really know and think about clinical trials? A comparison of rural and urban communities in the South. J Community Health 2013;38(4): 642–51. http://dx.doi.org/10.1007/s10900-013-9659-z Epub 2013/03/08. PubMed PMID: 23468319. The burden of heart disease and stroke in South Carolina. Columbia, SC: South Carolina Department of Health and Environmental Control: Heart Disease and Stroke Prevention Division; 2010.
[30] Getz KA. Restoring public confidence in clinical research: Lessons from the organ donation sector. The Monitor [Internet]. 2008 March 5, 2013; (September): [59–62 pp.]. Available from: http://216.147.199.31/Monitor/2008September/Getz2.pdf. [31] Len-Rios ME, Qiu Q. Negative articles predict clinical trial reluctance. Newsp Res J 2007;28:24–39. [32] Bergeron C, Foster C, Friedman DB, Tanner A, Kim S-H. Clinical trial recruitment in rural South Carolina: a comparison of investigators' perceptions and potential participant eligibility. Rural Remote Health 2013;13(4):2567. [33] Coleman-Phox K, Laraia BA, Adler N, Vieten C, Thomas M, Epel E. Peer reviewed: recruitment and retention of pregnant women for a behavioral intervention: lessons from the Maternal Adiposity, Metabolism, and Stress (MAMAS) study. Prev Chronic Dis 2013;10. [34] Bonevski B, Magin P, Horton G, Foster M, Girgis A. Response rates in GP surveys: trialing two recruitment strategies. Aust Fam Physician 2011; 40(6):1. [35] Andreason A. Marketing social change: changing behavior to promote health, social development, and the environment. San Francisco: JosseyBass; 1995. [36] Friedman DB, Corwin SJ, Dominick GM, Rose ID. African American men's understanding and perceptions about prostate cancer: why multiple dimensions of health literacy are important in cancer communication. J Community Health 2009;34(5):449–60. http://dx.doi.org/10.1007/ s10900-009-9167-3 [Epub 2009/06/12. PubMed PMID: 19517223]. [37] Comis RL, Crowley J, Unger J, Marinucci D, Catalano R, Colaizzi D, et al. Baseline study of patient accrual onto publicly sponsored U.S. cancer clinical trials: an analysis conducted for the global access project of the National Patient Advocate Foundation. Philadelphia, PA: Coalition of Cancer Cooperative Groups; 2006[April 21, 2009. Available from: http:// www.npaf.org/images/pdf/gap/sept_2006/cccg.pdf].