New US guidelines for decentralized and adaptive trials on the way
Impending US guidelines on decentralized trials should focus on safety, data integrity and address any outstanding questions around new research models says an industry group.
In January the Center for Drug Evaluation and Research (CDER) published its guidance agenda for 2023, stating clearly that it planned to issue guidelines on decentralized clinical trials before the end of the year.
The commitment was foreshadowed by the inclusion of a requirement for decentralized clinical trial (DCT) guidance in the US Government’s omnibus spending bill that President Joe Biden signed into law in December.
The law stated that the US Food and Drug Administration (FDA) should “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices” within a year.
Stakeholder engagement
Quite what will be included in the guidelines remains to be seen. However, previous comments by the FDA Oncology Center of Excellence (OCE) suggest the agency is taking a wide range of views into consideration.
In January the OCE wrote that it “supports efforts to modernize clinical trials and evidence generation” adding “COVID-19 provided a proof of concept for several decentralized trial modifications”.
It also said it “is engaging with stakeholders to evaluate the benefits and challenges seen with decentralized trials in order to prioritize streamlined procedures to deploy in future prospectively designed cancer clinical trials.”
Study access
These efforts were welcomed by Craig Lipset, co-chair of the Decentralized Trials & Research Alliance, who told Clinical Insider the FDA guidelines will need to both emphasize the benefits of this type of research and resolve any ambiguities.
“The FDA has been very supporting of efforts to improve both trial access as well as resilience through the use of decentralized trial methods. We anticipate seeing many themes coming together including maintaining a focus on patient safety and data integrity, the importance of the investigator in accessing data and supporting oversight, and the opportunities for data flow and integration.
“Guidance for FDA, alongside recommendations from EMA and publications from other global regulators, will remove perceptions of regulatory ambiguity among the research community and help support DCT adoption to realize our shared goal of improving study access” Lipset said.
DepositPhotos/gustavofrazao