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A Study In Contrasts: Eligibility Criteria In A Twenty-Year Sample Of Nsabp And Pog Clinical Trials, Abraham Fuks, Charles Weijer, Benjamin Freedman, Stanley Shapiro, Myriam Skrutkowska, Amina Riaz

Charles Weijer

We studied changes in eligibility criteria--the largest impediment to patient accrual--in two samples of clinical trials. Trials from the NSABP (National Surgical Adjuvant Breast and Bowel Program) and POG (Pediatric Oncology Group) were analyzed. After eliminating duplications, the criteria in each protocol were enumerated and classified according to a novel schema. NSABP trials contained significantly more criteria than POG trials, and added precision criteria (making study populations homogeneous) at a faster rate than POG studies. The difference between NSABP studies (explanatory trials) and POG studies (pragmatic trials) suggest that large numbers of eligibility criteria are not necessary for quality studies. …