A Study in Contrasts: Eligibility Criteria in a Twenty-Year Sample of NSABP and POG Clinical Trials

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 p...

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Bibliographic Details
Published inJournal of clinical epidemiology Vol. 51; no. 2; pp. 69 - 79
Main Authors Fuks, Abraham, Weijer, Charles, Freedman, Benjamin, Shapiro, Stanley, Skrutkowska, Myriam, Riaz, Amina
Format Journal Article Conference Proceeding
LanguageEnglish
Published New York, NY Elsevier Inc 01.02.1998
Elsevier
Subjects
Biological and medical sciences
Clinical trials
eligibility determination
ethics
General aspects
Medical sciences
neoplasms/treatment
patient participation
Planification. Prevention (methods). Intervention. Evaluation
Public health. Hygiene
Public health. Hygiene-occupational medicine
Clinical trials
neoplasms/treatment
ethics
patient participation
eligibility determination
Human
Clinical trial
Treatment
Therapeutic schedule
Malignant tumor
Performance requirement
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Summary: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. We recommend that: (1) the inclusion/exclusion criteria distinction be abandoned; (2) eligibility criteria be explicitly justified; (3) the need for each criterion be assessed when new trials are planned; (4) criteria in phase III trials restricting patient accrual be minimized; and (5) further research be done to assess the impact of criteria on generalizability.
ISSN:0895-4356
1878-5921
DOI:10.1016/S0895-4356(97)00240-0