Year: 2024
Type: editorial
Abstract: U ntil relatively recently, randomized clinical trials (RCTs) -as advanced by Sir Ronald Aylmer Fisher and the subject of his "Principles of Experimental Design" -remained the inviolate cornerstone for optimally validating the utility and safety of drugs, biological products, and devices. 1 Traditionally, most RCTs were conducted through coordination by a single central research site at academic medical centers.However, the conduct of RCTs grew increasingly challenging during the SARS-CoV-2 pandemic due to quarantines, site closures, and travel limitations, among other challenges.Mindful of this new reality, as well as of recent advancements in digital health technologies, the US Food & Drug Administration (FDA) issued Guidance for Industry, Investigators, and Institutional Review Boards on the Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency on March 13, 2020. 2This action not only facilitated the practical execution of clinical trials during the pandemic, but also incorporated the diversity-enhancing potential of alternative models for the conduct of clinical trials.More recently, on December 29, 2022, the FDA was tasked by the Food and Drug Omnibus Reform Act of 2022 (FDORA) to issue or revise "draft guidance with recommendations related to using decentralized clinical studies to support the development of drugs and devices." 3 FDORA, a component of the Consolidated Appropriations Act, 2023 [Public Law No:117-328], defined decentralized clinical trials (DCTs) as "a clinical study in which some or all of the study-related activities occur at a location separate from the investigator's location."3 The steps taken by the FDA to advance the cause of DCTs in response to FDORA as well as their potential implementation are delineated below.As per Section 3606 of FDORA, it was the expectation of Congress that "not later than 1 year after the date of enactment of this Act" the FDA will "issue or revise draft guidance that includes recommendations to clarify and advance
Authors: Eli Y. Adashi, Peter W. Marks
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,990
OpenAlex ID: W4396544298