Decentralized trials

Not just for a pandemic:
Decentralized trials "are here to stay, and they should be deployed in a fit-for-purpose manner"

Decentralized clinical trials are here to stay, and the long-term benefits outweigh the higher initial costs and technical challenges of remote studies.

That's according to a study by the Tufts Center for the Study of Drug Development, which compared published benchmarks on trial cycle times and costs with data from more than 150 decentralized trials conducted by trial software firm Medable. The verdict? “Substantial” potential benefits—including financial benefits.

The findings suggest industry use of decentralized trials will continue to increase, author Pamela Tenaerts, M.D., Medable's chief scientific officer, said in an interview.

Decentralized trials took off when the pandemic hit, and new guidance from the FDA and the European Medicines Agency clarified how companies could use decentralized elements to keep critical research going during lockdowns—or simply when patients and hospitals feared exposure, Tenaerts said.

“We have gained a lot more experience these last two years, and the benefits of DCTs are becoming clear, though they are still to be fully proven," she said. "What we’re doing today is showing that financially, there is return on investment when you deploy decentralized trials.”

Return on investment

For example, decentralized phase 2 studies are completed one to three months faster than traditional trials, the analysis found. These time savings yield “a net benefit that is up to five times greater than the upfront investment required,” the study said.

Decentralized phase 3 trials also finish more quickly than site-based equivalents. “Similar time savings yields a net benefit that is up to 14 times greater than the upfront investment required," the researchers wrote.

The study suggests decentralized trials have faster recruitment and higher retention rates than traditional studies. Plus, the decentralized versions need fewer review boards, which lowers regulatory costs and provides increased flexibility for protocol changes.

Tenaerts expects these returns to encourage industry to use decentralized and hybrid designs even as the coronavirus pandemic recedes. For these trials to work best, sponsors will need to consider the trial population, the disease area and the investigational product itself to determine how to best use these trial designs.

Decentralized trials "are here to stay, and they should be deployed in a fit-for-purpose manner," she said. "In some cases, this will mean hybrid trials and trials that reach patients where they are in the community and their homes; in some, a direct-to-patient trial will be a good fit.”