Copyright © 1989 Drug Information Association Inc. RECRUITMENT OF VOLUNTEERS FOR PHASE I AND PHASE II DRUG DEVELOPMENT STUDIES

Subject participation is crucial to drug development studies. Numbers of subjects are greatly reduced between the initial recruitment and study completion. The purpose of this study was to determine where major losses of subjects occurred and character ize the reasons why the subjects did or did not participate. All studies were con ducted at The Upjohn Research Clinics, Kalamazoo, Michigan, which comprise a 76- bed facility that specializes in Phase I and II trials. A 1987-1988 retrospective survey of 157 studies showed that of 9,028 subjects who met protocol entry criteria 5,906 (65%) attended the informed consent. Of the areas where subjects were lost, 3,122 (35 %) subjects failed to attend the informed consent and 2,073 (35 %) subjects withdrew between the informed consent and the start of the study or during the medical screen. After entry into the study, 247 (6%) subjects failed to complete the studies due to side effects or withdrawal on their own volition. The subjects popula tion was mainly white (92%), male (72%), and between 18 and 55 years of age, with black subjects (5%) and females (28%) represented the least. The greatest losses occurred due to failure to attend the informed consent or pass the medical screen. According to our data, we must recruit twice the number of volunteers needed to fulfill study requirements. Future investigation should be directed to identify those characteristics of poten tial volunteers who initially express an interest to participate in a study, but who decline to show up for the informed consent session