FDA Issues Guidances to Support Clinical Trial Innovation

The U.S. Food and Drug Administration (FDA) issued two draft guidances and one final guidance to support innovative clinical trial approaches. According to the agency, these approaches can increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges.

• Draft Guidance: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
  The draft guidance provides recommendations about how clinical trials can be moved into clinical practice settings, also known as "point of care trials". When finalized, the guidance will support the conduct of randomized controlled trials with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice. Comments can be submitted by 17 December 2024.
  
  
• Final Guidance: Conducting Clinical Trials With Decentralized Elements
  The final guidance provides recommendations for sponsors, investigators, and other interested community members regarding the implementation of clinical trials with decentralized elements. Decentralized elements allow trial-related activities to occur remotely  (e.g., telehealth visits, in-home visits with remote trial personnel, or visits with local health care providers) at locations that are convenient for trial participants. By enabling remote participation, decentralized clinical trials (DCTs) may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more patient populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility.
  
  
• Draft Guidance: Multiregional Clinical Trials in Oncology
  The draft guidance, when finalized, will provide sponsors with recommendations for conducting multiregional clinical trials (MRCTs) in support of applications for drugs intended to treat cancer. An MRCT is a trial that is conducted in more than one region under a single protocol, with region defined as a geographical region, country, or regulatory region. Comments can be submitted by 18 November 2024.