2026年3月21日,主要的健康和行业团体敦促FDA澄清贝叶斯临床试验方法指南,以确保透明度,严谨性和可重复性. On March 21, 2026, major health and industry groups urged the FDA to clarify guidelines for Bayesian clinical trial methods to ensure transparency, rigor, and reproducibility.

2026年3月21日,包括EFSPI,国际药学流行病学协会,儿科包容联盟,Regeneron制药公司,BIO和Insmed Inc.在内的多个组织提交了FDA关于其对临床试验中贝叶斯方法指导草案的公开意见. On March 21, 2026, multiple organizations including EFSPI, the International Society of Pharmacoepidemiology, the Pediatric Inclusion Alliance, Regeneron Pharmaceuticals, BIO, and Insmed Inc. submitted public comments to the FDA on its draft guidance for Bayesian methods in clinical trials. 他们敦促对模型透明度,先前数据使用和敏感性分析提出更明确,更一致的监管期望, 以确保科学严谨性和可重复性. They urged clearer, more consistent regulatory expectations around model transparency, prior data use, and sensitivity analysis to ensure scientific rigor and reproducibility. 支持者强调了改善试验效率,减少患者负担以及更好地整合现有证据等优点,特别是在儿科和罕见疾病研究中. Supporters highlighted benefits such as improved trial efficiency, reduced patient burden, and better integration of existing evidence, particularly in pediatric and rare disease research. 作为对创新试验设计指导的现代化努力的一部分,FDA正在审查反. The FDA is reviewing the feedback as part of its effort to modernize guidance on innovative trial designs.