NHIA Praises FDA Guidance Allowing Decentralized Clinical Trials

• By Laurie Watanabe
• May 11, 2023

The National Home Infusion Association (NHIA) voiced approval for new guidance issued by the U.S. Food & Drug Administration (FDA) that would allow for decentralized clinical trials.

In the May 2023 guidance, the FDA said, “This draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. In this guidance, a DCT refers to a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites.”

The guidance specifically allows for clinical trial activities to take place in participants’ homes: “These trial-related activities may take place at the homes of trial participants or in local healthcare facilities that are convenient for trial participants.” Some clinical trials could be “hybrid” in format, with some activities taking place in traditional clinical trial sites, while other activities take place in participants’ homes, the FDA added.

NHIA Comments on the Guidance

In a May 9 news announcement, the association said, “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 [Centers for Medicare & Medicaid Services] 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.’”