Recruitment of patients for clinical trials on psoriasis. A review of recent dermatological literature

: Reports of 62 psoriasis clinical trials listed in the Cumulated Index Medicus during 1988 and 1989, and published only in leading dermatological journals, were evaluated with respect to different elements of research methodology concerned with the recruitment of patients. The evaluation included items such as eligibility criteria, the sampling process, ethical considerations, and sample size calculation. Major weaknesses in the description of all aspects of the recruitment procedure were demonstrated. For example, a quantitative disease activity criterion at entry was mentioned in 15% of the studies, consecutive patients were included in 5% of the trials, approval from an ethics committee and informed consent of patients was mentioned in 16% of the studies and a pre-study sample size calculation was not mentioned in any of the trials.