Clinical research and evaluation of health products Platform trial

THERAPIE(2023)

引用 0|浏览26
暂无评分
摘要
For the past few years, platform trials have experienced a significant increase, recently amplified by the COVID-19 pandemic. The implementation of a platform trial is par-ticularly useful in certain pathologies, particularly when there is a significant number of drug candidates to be assessed, a rapid evolution of the standard of care or in situations of urgent need for evaluation, during which the pooling of protocols and infrastructure optimizes the number of patients to be enrolled, the costs, and the deadlines for carrying out the investiga-tion. However, the specificity of platform trials raises methodological, ethical, and regulatory issues, which have been the subject of the round table and which are presented in this article. The round table was also an opportunity to discuss the complexity of sponsorship and data management related to the multiplicity of partners, funding, and governance of these trials, and the level of acceptability of their findings by the competent authorities. (C) 2022 Published by Elsevier Masson SAS on behalf of Societe franc,aise de pharmacologie et de therapeutique.
更多
查看译文
关键词
Platform trial, Adaptive trial, Randomized controlled trial
AI 理解论文
溯源树
样例
生成溯源树,研究论文发展脉络
Chat Paper
正在生成论文摘要