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Impact of adaptive design on reducing the duration of clinical trials in rare cancers: a meta-analysis

Review question / Objective: Whether the application of adaptive design in clinical trials of rare cancers can shorten the duration of clinical trials? Condition being studied: Currently, the development of innovative drug products (InMPs) for rare cancers faces many challenges, including the difficulty of enrolling sufficient numbers of patients from small and heterogeneous patient populations for clinical trials, and the significant risks of high financial investment, long development times and potential failure from a pharmaceutical company's perspective for rare cancer drugs due to limited knowledge of the natural history of the disease. Therefore, alternative approaches to clinical trial design are needed to conduct cost-effective, well-controlled analyses that can assess treatment effects in small, heterogeneous populations within shorter time frames. Adaptive trials, on the other hand, may be an effective solution to this problem. Adaptive clinical trials are designed to accelerate the clinical trial process by making predefined adjustments to key parameters through data accumulated at predefined time points during the trial without compromising the integrity and validity of the results.This study aims to examine the value of adaptive design in reducing the duration of clinical trials in rare cancers and encourage their wider implementation.