FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory ...
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements o...
据FDA公告，该指南预计将于4月12日最终发布，目前公众可在网站上查看未发布的PDF版本。此外，FDA指出，一般来说，FDA的指导文件没有规定法律上可强制执行的责任。参考资料：1.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/risk-based-approach-monitoring-clinical-investigations-questions-...
Key words: Food and Drug Administration (FDA); master protocol; umbrella trial; platform trial; basket trial; concurrent control; guidance 近年来 ,精准医学研究的发展将分子靶向药物(MTA)研发推到一个新阶段 ,如何科学设计和评 估精准医学临床试验是 MTA 研发的关键.美国食 品药品管理局(FDA)针对精准医学...
Roles, responsibilities and operations of DMC; Increase in industry and government research collaborations; Increase in public concern over bias and conflicts of interest in clinical trials. INSET: Data Monitori...
1 FDA DRAFT GUIDANCE ON CLINICAL TRIAL DATA MONTORING COMMITTEES Susan S. Ellenberg, Ph.D. Office of Biostatistics and Epidemiology Center for Biologics. How does the process work? Submissions in 2007 (n=13,043) Perspectives. Bureau of Gastroenterology, Infection ...
“This draft guidance is timely and important. Criticism of the accelerated approval pathway has increased as multiple drugs approved under this mechanism remain on the market without completion of confirmatory studies.” wrote Lori J. Pierce, MD, FASTRO, FASCO, then-Chair of the B...
3.3 试验完整性和DMC 在比较型适应性设计中,最重要的就是限制与试验相关人员(包括受试者、申办方、研究者、管理人员等)得到期中分析的比较结果信息。当信息被相关人员泄露时,则试验的第Ⅰ类错误率的控制,估计值以及试验的有效性都可能受到挑战。同时,对于期...
guidance- documents-related-to-coronavirus-disease-2019-covid-19. Contains Nonbinding Recommendations Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards March 2020 Updated on August 30, 2021 For...
在大多数情况下,现有的DMC(如果不调整)不能替代安全评估委员会的作用,这一点已得到公认,因为DMC碰头太少并且通常只关注单一试验,而不是整个安全性数据库。当由于受试药无效或在明确显示一个重要的安全性终点有不良反应,而修改或停止研究时,DMC也向申请人提出建议。相反,安全评估委员会的作用是评价累积的安全性数据...