- Email: [email protected]
56P The perceived role of regional nurse coordinators in clinical trials
108S
Abstracts
is reflected in the characteristics of the study populations. regarding the characteristics of gender, race and age.
Conclusions will be drawn
55P AWARENESS OF CLINICAL TRIALS RESULTS AND INFLUENCE ON PRESCRIPTION BEHAVIOR: A SURVEY OF US PHYSICIANS Eleanor Schron, Yves Rosenberg, Albert Parker and Mario Stylianou
National Heart, Lung, and Blood Institute Bethesda, Maryland A telephone survey of 5776 randomly selected US physicians was conducted to assess the knowledge of the results and the impact on prescribing behavior after publication of clinical ~als: Systolic Hypertension in the Elderly Program (SHEP), Cardiac Arrhythmla Suppression Trial (CAST) and the Studies of Left Ventricular Dysfunction (SOLVD). Survey I was conducted in 1991 after publication of SHEP, SOLVD Treatment Trial, and CAST I; Survey II was conducted in 1992 after SOLVD Prevention Trial and CAST II. Survey I included 2113 eligible physicians (ie treating the medical conditions addressed by the trials), 1391 generalists (G) and 722 cardiologists (C). Survey II included 2056 physicians, 1264 G and 792 C. The response rates in the two surveys were 61.7 % and 62.8% respectively, not significantly different for G and C. At survey I, the trials names and/or their results were known by more than 70% of the physicians. Knowledge of the SOLVD trial significantly increased between the two surveys for G (79% to 91%) and for C (95% to 99%). Knowledge of the CAST trial signiiicantly decreased from 97% to 76% for C. Despite the SHEP results, there was no significant change reported in the initial use of diuretics or beta-blockers between the two surveys, 52% to 54%; chlorthalidonewas prescribed 34% to 35%. In conu-ast, in accordance with the results of SOLVD, the use of ACE inhibitors increased from 54 % to 66 % among G (p= < .01) and from 75 to 86% among C(p<.05). 77% of the G and 67% of the C who were prescribing encainide said they had stopped prescribing it after publication of the negative results of CAST I. Conclusion: this survey tends to demonsuate a good awareness of clinical trials results. However, prescription behavior is inconsistentlyaffected in one year by the results of the trials. 56P THE PERCEIVED ROLE OF REGIONAL NURSE COORDINATORS IN CLINICAL TRIALS Sylvia Martin, Eleanor Kent, Barb Aubrey,
Sharon Barnhili, Connie Liumi, Diane LaForge, Gall Burton
Universily of Alberta Edmonton, Alberta, Canada With the advent of large simple clinical trials involving a large number of investigators separated by long distances, a single coordinating centre may have difficulty coordinating these investigators effectively. An alternative may be to employ regional centres and Regional Nurse Coordinators (RNC's) as fiaison between the main coordinating centre and investigators. A survey, circulated to 119 Canadian investigators in a large clinical trials network, was used to assess the perceived value of the role of RNC's in clinical trials. In total, 80 (69%) of the surveys were returned and responses are summarized.
Abstracts
109S
Response to Survey Questions (%) Function Disagree Neutral Agree Clarifies info 2.6 11.3 85.1 Saves time 13.8 16.3 65.0 Saves labor 21.3 25.0 47.5 Simplifies recr* 25.1 35.0 35.1 Simplifies rand* 23.8 30.0 40.0 Problem-solving 7.5 8.8 82.6 Cost-efficieucy 10.1 26.3 43.8 Medical background 1.3 2.5 87.5 Improves admin* 3.8 11.3 77.6 These dat~ suggest that there is broad agreement by investigators about the role of regional coordinating centres and RNC's in clinical trials. Further systematic evaluation is needed to define the role of RNC's. (*recr-recruitment, *rand-randomiza6on, *admin-effective administration)
57P EFFECTIVE RECRUITMENT STRATEGIES FOR CLINICAL TRIALS IN RARE NEUROMUSCULAR DISEASES Barbara Herr, Lynn Cos, Cynthia Palenski, Shree Pandya and Norine Stirpe*
University of Rochester Medical Center Rochester, New York, and *Muscular Dystrophy Association, Tucson, Arizona Recruitment of patients with rare diseases for controlled clinical trials requires a thoughtful strategy. The Neuromuscular Disease Center at the University of Rochester is currently carrying out therapeutic trials in patients with Duchenne dystrophy, myotonic dystrophy, facioscapulohumeral dystrophy, amyotrophic lateral sclerosis, and the periodic paralyses. A large referral center such as ours may see annually only a few dozen patients or less with any one of these rare diagnoses. Although occurrence of these diseases is infrequent the disease process can be devastating to those affected: profound muscle weakness leading to steadily increasing loss of function and even death. There are no cures for any of these diseases so there is a pressing need for well designed trials of potential treatments. We have explored a number of avenues of subject recruitment including adverfsing in professional neurology publications, direct mailings to neurologists, listings in the General Clinical Research Center Rare Disease Protocol Database, and institutional press releases. The most effective approach by far has been to work with the local and national levels of the agency that provides support for these patients-in this instance the Muscular Dystrophy Association (MDA). When we want to inform patients that we are recruiting volunteers for a trial, MDA can help us by (1) Sending mailings which outline the study to all appropriate patients in a specified geographic area; (2) Sending information to the physicians who head the MDA clinics; (3) Releasing results of completed studies and plans for current trials to the national media; (4) Sponsoring local presentations for patients at which investigators can explain past findings, provide information about available therapies and current understanding of the pathomechanisms of the disease, and describe how these tie in with current research trials. These approaches ensure that virtually every patient registered with MDA is aware of the study and can make an informed decision whether to pa~cipate. Similar associations can provide a source for recruitment of patients for trials in other rare diseases.
Abstracts
is reflected in the characteristics of the study populations. regarding the characteristics of gender, race and age.
Conclusions will be drawn
55P AWARENESS OF CLINICAL TRIALS RESULTS AND INFLUENCE ON PRESCRIPTION BEHAVIOR: A SURVEY OF US PHYSICIANS Eleanor Schron, Yves Rosenberg, Albert Parker and Mario Stylianou
National Heart, Lung, and Blood Institute Bethesda, Maryland A telephone survey of 5776 randomly selected US physicians was conducted to assess the knowledge of the results and the impact on prescribing behavior after publication of clinical ~als: Systolic Hypertension in the Elderly Program (SHEP), Cardiac Arrhythmla Suppression Trial (CAST) and the Studies of Left Ventricular Dysfunction (SOLVD). Survey I was conducted in 1991 after publication of SHEP, SOLVD Treatment Trial, and CAST I; Survey II was conducted in 1992 after SOLVD Prevention Trial and CAST II. Survey I included 2113 eligible physicians (ie treating the medical conditions addressed by the trials), 1391 generalists (G) and 722 cardiologists (C). Survey II included 2056 physicians, 1264 G and 792 C. The response rates in the two surveys were 61.7 % and 62.8% respectively, not significantly different for G and C. At survey I, the trials names and/or their results were known by more than 70% of the physicians. Knowledge of the SOLVD trial significantly increased between the two surveys for G (79% to 91%) and for C (95% to 99%). Knowledge of the CAST trial signiiicantly decreased from 97% to 76% for C. Despite the SHEP results, there was no significant change reported in the initial use of diuretics or beta-blockers between the two surveys, 52% to 54%; chlorthalidonewas prescribed 34% to 35%. In conu-ast, in accordance with the results of SOLVD, the use of ACE inhibitors increased from 54 % to 66 % among G (p= < .01) and from 75 to 86% among C(p<.05). 77% of the G and 67% of the C who were prescribing encainide said they had stopped prescribing it after publication of the negative results of CAST I. Conclusion: this survey tends to demonsuate a good awareness of clinical trials results. However, prescription behavior is inconsistentlyaffected in one year by the results of the trials. 56P THE PERCEIVED ROLE OF REGIONAL NURSE COORDINATORS IN CLINICAL TRIALS Sylvia Martin, Eleanor Kent, Barb Aubrey,
Sharon Barnhili, Connie Liumi, Diane LaForge, Gall Burton
Universily of Alberta Edmonton, Alberta, Canada With the advent of large simple clinical trials involving a large number of investigators separated by long distances, a single coordinating centre may have difficulty coordinating these investigators effectively. An alternative may be to employ regional centres and Regional Nurse Coordinators (RNC's) as fiaison between the main coordinating centre and investigators. A survey, circulated to 119 Canadian investigators in a large clinical trials network, was used to assess the perceived value of the role of RNC's in clinical trials. In total, 80 (69%) of the surveys were returned and responses are summarized.
Abstracts
109S
Response to Survey Questions (%) Function Disagree Neutral Agree Clarifies info 2.6 11.3 85.1 Saves time 13.8 16.3 65.0 Saves labor 21.3 25.0 47.5 Simplifies recr* 25.1 35.0 35.1 Simplifies rand* 23.8 30.0 40.0 Problem-solving 7.5 8.8 82.6 Cost-efficieucy 10.1 26.3 43.8 Medical background 1.3 2.5 87.5 Improves admin* 3.8 11.3 77.6 These dat~ suggest that there is broad agreement by investigators about the role of regional coordinating centres and RNC's in clinical trials. Further systematic evaluation is needed to define the role of RNC's. (*recr-recruitment, *rand-randomiza6on, *admin-effective administration)
57P EFFECTIVE RECRUITMENT STRATEGIES FOR CLINICAL TRIALS IN RARE NEUROMUSCULAR DISEASES Barbara Herr, Lynn Cos, Cynthia Palenski, Shree Pandya and Norine Stirpe*
University of Rochester Medical Center Rochester, New York, and *Muscular Dystrophy Association, Tucson, Arizona Recruitment of patients with rare diseases for controlled clinical trials requires a thoughtful strategy. The Neuromuscular Disease Center at the University of Rochester is currently carrying out therapeutic trials in patients with Duchenne dystrophy, myotonic dystrophy, facioscapulohumeral dystrophy, amyotrophic lateral sclerosis, and the periodic paralyses. A large referral center such as ours may see annually only a few dozen patients or less with any one of these rare diagnoses. Although occurrence of these diseases is infrequent the disease process can be devastating to those affected: profound muscle weakness leading to steadily increasing loss of function and even death. There are no cures for any of these diseases so there is a pressing need for well designed trials of potential treatments. We have explored a number of avenues of subject recruitment including adverfsing in professional neurology publications, direct mailings to neurologists, listings in the General Clinical Research Center Rare Disease Protocol Database, and institutional press releases. The most effective approach by far has been to work with the local and national levels of the agency that provides support for these patients-in this instance the Muscular Dystrophy Association (MDA). When we want to inform patients that we are recruiting volunteers for a trial, MDA can help us by (1) Sending mailings which outline the study to all appropriate patients in a specified geographic area; (2) Sending information to the physicians who head the MDA clinics; (3) Releasing results of completed studies and plans for current trials to the national media; (4) Sponsoring local presentations for patients at which investigators can explain past findings, provide information about available therapies and current understanding of the pathomechanisms of the disease, and describe how these tie in with current research trials. These approaches ensure that virtually every patient registered with MDA is aware of the study and can make an informed decision whether to pa~cipate. Similar associations can provide a source for recruitment of patients for trials in other rare diseases.