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INTRODUCTION Since the 1970s, the gold standard of study assessing the efficacy of new anticancer drugs has been randomized controlled trials (RCTs), especially phase 3 trials.1 One of the major controversial issues in cancer clinical trials is eligibility criteria. These criteria have two main purposes. First, by defining a homogeneous study group, they ensure adequate internal validity of a clinical trial. Second, they ensure the safety of trial participants.
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