A Comparative Analysis of the Main Characteristics and Consistency Evaluation Methods between Bridging Studies and Multi-Regional Clinical Trials
Objective:To compare the similarities and differences between foreign clinical trial data bridging studies and multi-regional clinical trials(MRCT)for confirming drug efficacy.It also provides insights into the different considerations in methodology from a statistical perspective.Methods:ICH guidelines for bridging studies and MRCT,as well as literature related to the evaluation method of the consistency of treatment effects across regions,are collected.Representative rules,methods,and opinions from these documents are summarized and analyzed.Results:Similarities between the two include the shared goal of minimizing duplication of clinical studies,the necessity to meet regulatory requirements in each target region,and the need to evaluate the consistency of treatment effects among regions.Both definitions also intersect with each other.Differences,however,encompass varying preconditions for implementation,different sequences of implementation,distinct design ideas for clinical trials,diverse considerations of primary endpoints,discrepant considerations of sample size,and dissimilar evaluation methods for the consistency of treatment effects among regions.In essence,bridging studies should not be trials with a small sample size that depend on foreign clinical trials.In MRCT,regulators in the target region should emphasize the inflation degree of the type I error rate when deciding the consistency of treatment effects.Conclusion:The identified differences determine that the designs and evaluations of bridging studies and MRCT should not be mixed in methodology.Bridging studies should be complete and independent of foreign clinical trials.The consistency of treatment effects between the target region and MRCT can be evaluated by adjusting the nominal significance level of the target region.
万方数据
维普
