Ellenberg Susan S, Li Yimei
Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA.
Ther Innov Regul Sci. 2025 Mar;59(2):211-214. doi: 10.1007/s43441-024-00728-0. Epub 2025 Jan 8.
It has long been a basic principle of randomized clinical trials addressing serious outcomes and/or major public health issues that interim data should be inaccessible to investigators and to industry sponsors, with interim data reviewed on a regular basis by an independent data monitoring committee (DMC). Challenges to this principle may arise when sponsors and/or regulators perceive a need to review interim data while the trial remains ongoing-for example, when a trial is being considered for accelerated approval. In this paper we propose approaches that could minimize the extent of interim data that is made available to others while the trial continues.
长期以来，针对严重结局和/或重大公共卫生问题的随机临床试验的一项基本原则是，研究人员和行业赞助商无法获取中期数据，中期数据由独立的数据监测委员会（DMC）定期审查。当赞助商和/或监管机构认为在试验仍在进行时需要审查中期数据时，可能会对这一原则提出挑战——例如，在考虑加速批准一项试验时。在本文中，我们提出了一些方法，这些方法可以在试验继续进行时尽量减少向他人提供的中期数据的范围。
