中国医学前沿杂志（电子版）2026，Vol.18Issue(1)：25-31,7.DOI:10.12037/YXQY.2026.01-04
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
Application and development of the SPIRIT and CONSORT guidelines
摘要
Abstract
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.关键词
临床试验报告统一标准/临床试验方案规范指南/报告清单/研究进展Key words
CONSORT/SPIRIT/Reporting checklists/Study progress引用本文复制引用
李志强,刘建平..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[J].中国医学前沿杂志（电子版）,2026,18(1):25-31,7.基金项目
国家中医药管理局高水平中医药重点学科建设项目—中医药循证医学(zyyzdxk-2023249) The High-level Traditional Chinese Medicine Key Subject Construction Project of National Administration of Traditional Chinese Medicine-Evidence-based Traditional Chinese Medicine(zyyzdxk-2023249) （zyyzdxk-2023249）
