Decentralized Clinical Trials Empower the Participant and Enhance Health Equity

A precious resource within healthcare is underutilized — the individual, family, and informal care team. Beyond “traditional” healthcare, clinical trials are another place where these resources have not been adequately leveraged.

On average, it costs $6,533 simply to recruit a participant for a clinical study. And post-recruitment, with almost 40-percent patient non-adherence, the average cost to replace a participant is $19,533. Notwithstanding these high-cost structures, systemic bias remains in the system where, for example, African Americans, who reflect 13% of the U.S. population, typically only comprise 5% of clinical trial participants. Addressing recruitment, administration, and non-adherence is critical in terms of cost, outcomes, and time. Although there are many reasons for both the high cost of recruitment and the low adherence rates, a significant issue raised by participants is the substantial burden of participation (e.g., many visits, time away from work or family, lengthy questionnaires, costs).

Accelerated by COVID, the delivery of these trials is beginning to evolve as technology is used to support and expedite decentralized clinical trials (“DCT”). However, these technology tools tend to benefit the trial administration rather than the trial participant.

As an example, Threat Research and AWS recently announced that they would work together to develop advanced machine learning architecture and artificial intelligence models to automate processes…reduc[ing] inefficiencies, and [allowing] auto-populat[ion of] data workflows that are currently performed manually. And ConcertAI’s software has reduced the time for study design and clinical trial execution by up to 25%.

While these are exciting developments, a recent survey identified that virtual trial platforms, relationship management portals, and patient experience platforms still had only 5%-6% adoption rates by study sponsors. We can impact clinical trials by focusing on a broader range of participants and support networks.

While DCTs begin to blur geographic constraints by reducing the need for participants to travel to study sites, travel is not the only impediment. Here are some relatively simple ways to use technology to ease the DCT process and bring more health equity to the system.

• Adherence and clinical innovation can substantially improve by helping families and caregivers understand and participate in the process through a patient-centered platform.
• The process is made less daunting by providing participants with “collaborative care plans” that are presented as simple “activities” initiated through phone or web alerts (and can be shared and viewed by family and caregivers).
• Early interventions are facilitated as issues arise, with no additional burden or intrusion, by sharing responses to activities and enabling the ongoing monitoring of progress and protocol compliance.
• Participants can be comforted and anxiety reduced through asynchronous communication amongst various parties to address questions or issues as they arise.

By increasing the focus on the participant and their care team, the overall experience can be changed. A more approachable trial is created, appealing to a broader and more diverse participant pool more reflective of society:

• A working parent can interact based on their schedule, not that of the site;
• A family member in Chicago can help monitor their parent’s progress and compliance in Phoenix;
• Potential participants in rural settings can participate without the requirement of a three-hour drive to a clinical setting or:
• A family in St. Louis can participate in an ALS trial based in Detroit.

Addressing the immediate and indirect needs of trial participants is critical to the evolution of DCT and the more efficient and equitable delivery of clinical trials.

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