Advocacy News

FDA Issues Guidance for Decentralized Clinical Trials

May 9, 2023

NHIA applauds the guidance issued by FDA to allow for decentralized clinical trials, including in patients’ homes. NHIA first commented on this topic to CMS in our letter regarding the National Coverage Analysis for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease on Jan. 11, 2022, which would have limited studies to hospital outpatient settings. As NHIA noted in its letter, during the COVID-19 public health emergency, several manufacturers successfully conducted clinical trials in remote settings, including patients’ homes. 

NHIA believes that allowing decentralized clinical trials will improve the representation of a wider range of patients in trials. According to the FDA guidance, “remote clinical trial visits and clinical trial-related activities are important strategies to make trials more convenient and more accessible” and “sponsors should strive for diversity and inclusiveness in trial populations.” 

The FDA also shares guidance for enabling in-person visits and trial-related activities to be provided by HCPs close to trial participants’ homes but are not a part of the trial personnel as well as collecting informed consent remotely.

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