DCTs: Bringing it all back home
The glossary of terms put out by the Decentralized Trials & Research Alliance defines decentralized clinical trials (DCTs) as “A clinical trial utilizing technology, processes, and/or services that create the opportunity to reduce or eliminate the need for participants to physically visit a traditional research site.”
This bears repeating: DCTs reduce or eliminate the need for participants to physically go to a traditional research site. So what does this mean?
By bringing the trial to the participant (at their home and/or nearby clinic), DCTs remove the big geographical blockers and open up the size and inclusivity of the participant pool.
By bringing the trial to the participant, DCTs remove the big geographical blockers and open up the size and inclusivity of the participant pool.
Who’s in? People who are reluctant to spend time in hospital settings, have family commitments, or deal with inflexible work or school schedules. They’re in and that’s all good. But the real bonus is that decentralized trials give more opportunity to women, racial and ethnic minorities, and those with rare diseases to become a part of clinical research. People like Anna. Their participation helps make sure that the medical solutions being developed and tested work as intended—not just for a select few, but for the broadest possible range of people.
Are DCTs the be-all and end-all of clinical research?
Short answer: No.
There are some tests and procedures that simply must be done in a clinical setting. But the use of DCTs is growing for many, many research opportunities. This means decentralized clinical trials can and should be considered where feasible.
Just a caveat here: Not all DCTs are completely virtual, with all aspects of the research conducted from home relying solely on digital reporting and monitoring technologies. So-called hybrid trials may include visits from nurses or require the participants to make one or two visits to a nearby clinic. DCTs may be constructed differently, but that’s OK, as long as they are meeting the needs of the participants.
Have DCTs proven themselves?
DCTs began mostly as a way to continue clinical research during the Covid pandemic. Since then, DCTs have grown legs and taken off. While research on DCTs is somewhat limited to date, it’s increasing.
So what do we know? What are healthcare consumers saying about their interest in clinical trials—especially decentralized trials that use remote technologies? In a recent survey of 1,183 cancer patients and survivors, they shared that only 18% had participated in a cancer clinical trial. But 77% were interested in joining a trial if it was located as close as their regular healthcare provider. Older patients (55 years and older) were much more reluctant to join trials if they had to travel farther than their provider’s office. So in the healthcare consumers’ minds, trials are good. Travel, not so much.
What really stands out in this survey? When questioned about using remote methods and technologies, 80+% said they would happily agree to using remote options, such as “oral medications delivered and taken at home, providing informed consent electronically, and using apps or wearables.”
We’ve seen good results in our own support of decentralized trials, with a trial of a new in-home test for colon cancer. The participants were able to perform and submit the test from home, greatly increasing the pool of participants. While they did have to receive a colonoscopy for comparison to the test results, they could do so at nearby providers. A huge benefit was that more people who needed to be tested were able to do so.
83% of potential patients did not have a colonoscopy previously scheduled before they became involved in the qualification process.
This important trial made it possible for a new product to be developed that helps catch colorectal cancer at an early stage and helps extend the lives of those diagnosed with the disease.