临床试验方案规范指南与临床试验报告统一标准的应用与发展OA

Randomized controlled trials(RCTs),recognized as the"gold standard"for evaluating intervention efficacy,and the quality of an RCT depends on its rigorous design and implementation.However,many current RCTs suffer from various problems,such as missing key information,inconsistencies between protocol and results reporting,selective reporting,and irreproducible results.These issues seriously affect the quality and credibility of the studies.Against this backdrop,the standard protocol items:Recommendations for interventional trials(SPIRIT)and the consolidated standards of reporting trials(CONSORT)have emerged as essential frameworks for clinical trial quality assurance.Following the complete and transparent reporting in accordance with CONSORT/SPIRIT guidelines helps enhance the verifiability of research results and reduces the bias of selective reporting.In April 2025,the SPIRIT 2025 and CONSORT 2025 guidelines were updated simultaneously to ensure full-cycle transparency and integrity,from protocol design to results reporting,thereby jointly improving the overall quality of clinical trials.Nevertheless,the practical application of these guidelines encounters many challenges.This review synthesizes the historical development of the SPIRIT and CONSORT guidelines over the past two decades and details their latest iterations,aiming to provide references for their clinical application.