Decentralized trials (DCTs) hold tremendous potential to raise overall enrollment numbers and achieve a better, more diverse racial/ethnic balance. This objective matters not just because it is equitable, but because precision medicine hinges on achieving greater research diversity. If everyone in a trial looks the same, we learn little about how medicines perform in the real world.
In 2021, a large global survey engaging nearly 12,000 individuals, 76% said clinical research was “very important” to the discovery and development of new medicines. Patients and advocacy organizations recognize that participating in studies may be the gateway to receiving advanced therapies. And yet in practice, just 8% of cancer patients enroll in trials. The FDA and other health authorities believe DCTs can help.
How Hybrid DCTs Can Be Game Changers
- Accessibility: A primary impetus for DCTs is improving patient comfort and convenience. The 2019 meta-analysis by the Hutchinson Cancer Center examined data on nearly 9,000 cancer patients in 13 studies. More than half of all individuals (55%) did not participate in trials because appropriate studies were unavailable at medical institutions that treated them. DCTs can help address this roadblock.
- Availability and opportunity: For members of socially disadvantaged groups, well-known challenges are magnified. In the US, people in poorer communities are less likely to hear about studies and are more exposed to “hidden costs,” including travel to and from clinics, the need for extra childcare and the loss of income due to missed work.
- Safety: COVID-19 cast social disparities in harsh relief, even as it plunged trial subjects and investigators into dangerous new waters. In many cases, the only option for keeping studies on track was to harness digital technology and remote nursing teams so patients could remain safe at home.
- Virtual options: For many cancer trials with complex dosing requirements and the need for tumor assessment via CT, MRI or PET imaging, truly “site-less” trials were never an option. Instead, in close communication with the FDA, US sponsors and clinical teams designed studies combining traditional and virtual approaches.