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P27 Data monitoring issues in cancer screening trials
438
Abstracts
P27 DATA MONITORING ISSUES IN CANCER SCREENING TRIALS Barbara L. Wells and Philip C. Prorok
National Cancer Institute Bethesda, Maryland
Effective screening tests for cancer are an integral component of the goal of reducing the cancer mortality rate in the U.S. Although it is crucial to monitor cancer screening trials to assure they proceed according to protocol and yield an optimal amount of information, little has yet been done to study monitoring methodologies on screening trials. This report investigates the application of medical clinical trials methodology to monitoring screening trials, and investigates the use of methods for selected screening trials conducted to date. Information will be presented in several categories, including: defining parameters of the study population; protocol and design compliance; nature of the disease and screening test; adverse effects; data acquisition; and treatment comparisons and evidence of an intervention effect, including proxy outcome measures and mortality rate assessment. The National Cancer Institute is about to launch a large trial to test the effectiveness of screening tests for four cancers. It is expected that in the future additional screening tests will be developed and those will also undergo trials to test their over-all effectiveness. This report provides the basis for important issues to be considered in the design and conduct of such trials. P28 PROMOTING ENROLLMENT IN A MULTI-CENTER CLINICAL TRIAL
Alice Rudolph, Rita M. Pelusio, Jeannette McManus, Kathy L. Bordwell, Karl Kieburtz, Ernest Dorflinger, Ira Shoulson, and the Parkinson Study Group
University of Rochester Rochester, New York
Subject enrollment in multi-center clinical trials may fall behind schedule or fail to meet quotas. We used 4 techniques to facilitate attainment of our goal of enrolling 300 early Parkinson's disease patients within 10 months at 18 US & Canadian sites. Participating sites were requested to fax Enrollment Projections Sheets weekly to the Coordination Center. The projection sheets [isling potential subjects identified to date & their anticipated enrollment dates allowed for continual central monitoring of enrollments projected out to 90 days in 30 day blocks. The projections, plus actual enrollments tracked by an on-line enrollment process, were tallied by site in a weekly Enrollment Status Report. The Steering Committee used these reports in decisions about site retention & motivational approaches. Sites received the reports, without site names, showing relative position thus avoiding unhealthy competition but allowing comparison of performance relative to site and study goals. A weekly newsletter focused on recruitment tips & protocol clarifications to additionally motivate participating investigators and coordinators. P29 RECRUITMENT OF BREAST CANCER PATIENTS TO CLINICAL TRIALS: GENERAL ISSUES AND BARRIERS Laura A. Shninoff and Charles W. Lidz
University of Pittsburgh Pittsburgh, Pennsylvania
Approximately 150,000 women were diagnosed with breast cancer (BC) in the U.S. in 1990; this is a figure that has increased yearly during the past decade. Nonetheless, despite the large numbers of patients (Pts) this disease affects each year and the numerous cooperative groups which conduct clinical trials (CTS) in this area, only 2 % of BC Pts participate in CTs aimed at improving therapy. This paper will report on dat_~ from an on-going study which is examining the social and institutional barriers to the successful recruitment of BC Pts to CTS. Study sample is 300 trial eligible Pts and their physicians (Phys); both surgeons and medical oncologists. The problems attendant to recruitin.g Pts efficiently to trials distorts the randomization ~process, creates sampling biases and eomprormses trial generalizability. This paper will exarmne how institutional, situational and Pt and Phys individual factors affect the recruitment of Pts to CTS. The paper will also seek to dispel certain eommoniy held assumptions about this problem. For example,
Abstracts
P27 DATA MONITORING ISSUES IN CANCER SCREENING TRIALS Barbara L. Wells and Philip C. Prorok
National Cancer Institute Bethesda, Maryland
Effective screening tests for cancer are an integral component of the goal of reducing the cancer mortality rate in the U.S. Although it is crucial to monitor cancer screening trials to assure they proceed according to protocol and yield an optimal amount of information, little has yet been done to study monitoring methodologies on screening trials. This report investigates the application of medical clinical trials methodology to monitoring screening trials, and investigates the use of methods for selected screening trials conducted to date. Information will be presented in several categories, including: defining parameters of the study population; protocol and design compliance; nature of the disease and screening test; adverse effects; data acquisition; and treatment comparisons and evidence of an intervention effect, including proxy outcome measures and mortality rate assessment. The National Cancer Institute is about to launch a large trial to test the effectiveness of screening tests for four cancers. It is expected that in the future additional screening tests will be developed and those will also undergo trials to test their over-all effectiveness. This report provides the basis for important issues to be considered in the design and conduct of such trials. P28 PROMOTING ENROLLMENT IN A MULTI-CENTER CLINICAL TRIAL
Alice Rudolph, Rita M. Pelusio, Jeannette McManus, Kathy L. Bordwell, Karl Kieburtz, Ernest Dorflinger, Ira Shoulson, and the Parkinson Study Group
University of Rochester Rochester, New York
Subject enrollment in multi-center clinical trials may fall behind schedule or fail to meet quotas. We used 4 techniques to facilitate attainment of our goal of enrolling 300 early Parkinson's disease patients within 10 months at 18 US & Canadian sites. Participating sites were requested to fax Enrollment Projections Sheets weekly to the Coordination Center. The projection sheets [isling potential subjects identified to date & their anticipated enrollment dates allowed for continual central monitoring of enrollments projected out to 90 days in 30 day blocks. The projections, plus actual enrollments tracked by an on-line enrollment process, were tallied by site in a weekly Enrollment Status Report. The Steering Committee used these reports in decisions about site retention & motivational approaches. Sites received the reports, without site names, showing relative position thus avoiding unhealthy competition but allowing comparison of performance relative to site and study goals. A weekly newsletter focused on recruitment tips & protocol clarifications to additionally motivate participating investigators and coordinators. P29 RECRUITMENT OF BREAST CANCER PATIENTS TO CLINICAL TRIALS: GENERAL ISSUES AND BARRIERS Laura A. Shninoff and Charles W. Lidz
University of Pittsburgh Pittsburgh, Pennsylvania
Approximately 150,000 women were diagnosed with breast cancer (BC) in the U.S. in 1990; this is a figure that has increased yearly during the past decade. Nonetheless, despite the large numbers of patients (Pts) this disease affects each year and the numerous cooperative groups which conduct clinical trials (CTS) in this area, only 2 % of BC Pts participate in CTs aimed at improving therapy. This paper will report on dat_~ from an on-going study which is examining the social and institutional barriers to the successful recruitment of BC Pts to CTS. Study sample is 300 trial eligible Pts and their physicians (Phys); both surgeons and medical oncologists. The problems attendant to recruitin.g Pts efficiently to trials distorts the randomization ~process, creates sampling biases and eomprormses trial generalizability. This paper will exarmne how institutional, situational and Pt and Phys individual factors affect the recruitment of Pts to CTS. The paper will also seek to dispel certain eommoniy held assumptions about this problem. For example,