Almost half of clinical trials run late, year after year. Why does this happen? The biggest delaying factor is finding enough patients, and the delay starts with the clinical trial protocol. The protocol includes the inclusion and exclusion criteria that define the patients who are eligible for the study. Criteria are growing in complexity, and the sponsor may not find the patients needed because too few meet the criteria. If the patients do exist, it is difficult to find the clinical trial investigators who treat them. This article examines the trends in…
Figure 1. Major Inclusion & Exclusion Criteria
Figure 2. Average Delays in Clinical Trials
Figure 3. Schizophrenia Patient Counts
Bill Gwinn, VP, Clinical Informatics Solutions, QualityMetric Inc.