FDA sets out its thinking on decentralised clinical trials

The FDA has issued draft guidance on the use of decentralised clinical trials (DCTs), which are increasingly being used by the pharma industry to tackle issues, such as diversity and inclusivity, in clinical research.

The new guidance – required by the passage of the FDA Omnibus Reform Act (FDORA) last year – provides recommendations for trial sponsors, investigators and others involved in clinical trials on how to carry out activities at locations other than traditional investigation sites.

That could include obtaining laboratory tests at a local facility rather than a research-active medical centre or conducting a clinical follow-up visit in the trial participant’s home using telemedicine, said the regulator in a statement.

The move comes a few months after the EU also published recommendations intended to encourage the use of DCTs and safeguard the wellbeing of those participating in them.

The FDA’s guide covers DCT design, remote clinical trial visits and other activities, the use of digital health technologies as enablers of studies, the roles and responsibilities of sponsors and investigators, and how investigational medicine should be administered.

It also lays out the agency’s current thinking on informed consent, review board oversight, packaging and shipping of investigational medicines and the factors that should be considered in drawing up a safety monitoring plan.

The FDA first issued guidance on DCTs in 2020, out of necessity when the world was grappling with lockdowns in response to the COVID-19 pandemic, but it says the new version considers what has been learned about remote trials since then.

“Advancements in digital health technologies and the COVID-19 pandemic…have accelerated the broader adoption of these activities,” commented FDA Commissioner Robert Califf.

“As we seek to improve our evidence generation system, decentralised clinical trials may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility.”

While many studies deployed decentralised elements even before the pandemic, the approach has been latched onto by the pharma sector as it tries to make its trial populations for new medicines more representative of the patients who will eventually use them.

In particular, it has long been a concern that racial and ethnic minorities are often very under-represented in studies, and carrying out studies in diverse communities is one way to tackle that issue.

There has already been a shift to trialling patients in their own homes and local clinics, and latterly new players have entered the area such as pharmacy chains, who promise to use their retail networks to find and enrol study subjects.

Comments on the new guidance will be accepted by the FDA until 1st August.