Evaluation of the representativeness and generalizability of Japanese clinical trials for localized rectal/colon cancer: Comparing participants in the Japan Clinical Oncology Group study with patients in Japanese registries

摘要

Introduction: It is unclear if clinical trial results including patients who meet trial eligibility criteria, are applicable to actual patients in daily practice (generalizability). Moreover, the extent to which are trial participants different from patients seen in daily practice (representativeness) is also unclear. The aim of this study was to evaluate the representativeness of the patients registered in randomized clinical trials to patients in daily practice and examine the generalizability of trial results to daily practice.