基于CDISC标准的生物等效性试验基本数据集构建与应用OA

Objective To address issues such as low efficiency and poor consistency in the submission of bioequivalence trial data under the Clinical Data Interchange Standards Consortium standards,this study aimed to develop a set of reusable standardized core data sets to improve data preparation efficiency and regulatory submission quality.Methods A systematic review of multiple approved BE trial projects was conducted,covering different trial designs,dosage forms,and study types.Common data structures and mapping rules were extracted through business analysis,and standardized data set templates covering both SDTM and ADaM layers were developed in strict accordance with CDISC standards.Results This study summarized 274 SDTM and 338 ADaM data element-specific attributes applicable to bioequivalence trials.A set of standardized core data sets suitable for most BE trial scenarios was established and successfully applied in a two-formulation,two-period,two-sequence crossover BE study evaluating a gel patch.Conclusion The standardized dataset constructed in this study provides a preliminary framework for the standardization of BE trial data,which requires further validation through large-scale applications to clarify its applicability and robustness in enhancing the standardization level and work efficiency of BE trial data processing.It holds significant practical value for ensuring data quality and improving the success rate of submissions,while also serving as a referenceable example for the development of foundational datasets within the industry.