FDA's Guidance for Decentralized Clinical Trials

The FDA published a draft guidance on decentralized clinical trials (DCTs). Comments are requested by 1 August 2023. Examples of decentralized elements include obtaining laboratory tests at a local facility rather than a research medical center or conducting a clinical follow-up visit in the trial participant's home. In fully decentralized clinical trials, all activities take place at locations other than traditional trial sites. In hybrid DCTs, some trial activities involve in-person visits by trial participants to traditional clinical trial sites, and other activities are conducted at locations other than traditional clinical trial sites.

Advancements in digital health technologies (DHT) and the COVID-19 pandemic have accelerated the broader adoption of these activities. Thus, the FDA's new guidance covers recommendations on topics such as: 

  • Design considerations for a DCT;
  • Conduct of remote clinical trial visits and clinical trial-related activities;
  • Use of DHTs to remotely acquire data;
  • Roles and responsibilities of the sponsor and investigators;
  • Obtaining informed consent (IC) and institutional review board oversight of the IC process;
  • Determination of the appropriateness of investigational medicinal products (IMPs);
  • Packaging and shipping of IMPs;
  • Safety monitoring of trial participants.

Digital Health Technologies (DHTs)

DHTs may allow transmission of data remotely from trial participants wherever they are located. The draft guidance "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations" provides recommendations to sponsors, clinical investigators, and other parties for measuring clinical events and characteristics of interest using DHTs to acquire data remotely from participants in clinical trials for drugs, biological products, and devices. Sponsors should ensure that DHTs used in a DCT are available and suitable for use by all trial participants.

For more information please see FDA's draft guidance "Decentralized Clinical Trials for Drugs, Biological Products, and Devices".

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