FDA Releases Draft Guidance On Decentralized Clinical Trials

US Food and Drug Administration has come up with a novel draft guidance in order to further support the use of decentralised clinical trials when it comes to drugs, biologics, and devices. The publication has in it recommendations from investigators, sponsors, as well as other stakeholders when it comes to the implementation of DCTs so as to advance medical product development as well as research.

Under decentralised clinical trials, some or all of the clinical trial activities appear at locations other than the traditional sites. Instances of these activities include getting laboratory tests done at a local facility rather than going to a research medical centre or conducting a clinical follow-up visit at the trial participant’s home by way of telemedicine.

By reducing the hurdles to participation, the FDA expects that the decentralised clinical trials will enhance the range and diversity of the participants and also improve accessibility for those who have rare diseases or are suffering from mobility challenges. All said and done, the regulatory body thinks that the approach will result in enhanced treatment options and better patient outcomes.

As per the FDA, the new draft guidance when it comes to the DCTs goes on to cover recommendations on topics such as:

  • Considerations related to DCT design.
  • Conduct of the remote-control trial visits as well as activities related to DCTs.
  • Usage of digital health technology so as to remotely acquire the data.
  • Responsibilities as well as the role of the sponsors and investigators conducting the DCT.
  • Getting informed consent (IC) and an oversight from the institutional review board of the process of IC within the DCT.
  • Determining the appropriateness of the investigational products in terms of their use in a DCT.
  • Investigational product packaging and shipping in a DCT.
  • Monitoring the safety of DCT enrolees.

The draft guidance goes on to build on the recommendations that were published by the agency in 2020. These earlier recommendations did give clarity to the investigators so as to facilitate trial decentralisation in response to the pandemic, thereby helping to overcome barriers such as site closures and travel limitations.

According to Dr. Robert M. Califf, the progress in digital health tech and the COVID-19 pandemic, during which in-person visits were limited or in fact unavailable for many participants, have gone on to accelerate the widespread adoption of these activities. It should be taken into account that the FDA’s regulatory requirements in terms of medical product investigations for DCT as well as traditional site-based clinical trials happen to be the same.