Decentralized Clinical Trials: Empowering Participants, Expanding Access, and Reducing Costs

Decentralized Clinical Trials: Empowering Participants, Expanding Access, and Reducing Costs

A precious resource in healthcare remains underutilized: the individual, their family, and their informal care team. This is particularly true in clinical trials, where participant-centered approaches have historically been overlooked, and where underrepresentation, high costs, and poor retention hinder access and scientific outcomes.

Recruitment and retention are among the most persistent barriers. The average cost to recruit a participant is approximately $6,500, and replacing a participant due to dropout or non-adherence can cost more than $19,500.¹ Despite these investments, nearly 40% of clinical trial participants do not complete the trial, often due to burdensome protocols, logistical barriers, and a lack of support.² These challenges disproportionately affect underrepresented groups, compounding systemic inequities. As an example, Black Americans represent 13% of the U.S. population but just 5% of clinical trial enrollees.³

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Accelerated by the COVID-19 pandemic, Decentralized Clinical Trials (DCTs) have emerged as a transformative model. By incorporating telehealth, remote monitoring, eConsent, and home delivery of investigational drugs, DCTs offer the potential to reduce site dependence, lower geographic barriers, and improve enrollment timelines. According to a 2023 Tufts Center for the Study of Drug Development report, DCTs can reduce study timelines by up to 30% and improve patient retention by more than 20%.⁴

However, much of the innovation in DCTs has focused on operational efficiencies for sponsors and CROs. For example, platforms like ConcertAI and Medable have demonstrated reduced trial cycle times and improved protocol adherence using digital tools.⁵

A 2022 Deloitte survey found that only 5% to 6% of study sponsors had adopted platforms supporting patient experience, communication, or care coordination, key enablers of trust and participation, particularly in underserved populations.⁶

To realize the full promise of DCTs, we must broaden our lens to include trial participants' daily lives, needs, and networks. This means embedding trials within the personal ecosystems surrounding individuals — care partners, family members, social supports — and empowering those networks to participate actively in adherence and navigation.

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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 be substantially improved 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.
  

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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 the site's limited hours.
• A family member in Chicago can help monitor their parents’ progress and compliance in Phoenix.
• Potential participants in rural settings can participate without requiring a three-hour drive to a clinical setting.
• A family in St. Louis can participate in an ALS trial based in Detroit.

Studies show that this model works: a 2021 study published in NPJ Digital Medicine found that patients supported by digital engagement tools and caregiver collaboration demonstrated 33% higher protocol adherence, 25% lower dropout, and reported greater satisfaction with the trial experience.⁷

In addition to engagement and support tools, a personalized Resource Center featuring documents, videos, and protocol walkthroughs can empower participants and their families to better understand expectations and avoid confusion or drop-off. Paired with real-time engagement, such a resource can dramatically enhance understanding and confidence.

Further, by integrating device-based or deviceless monitoring and enabling participant- and family-generated data, trials can capture richer insights on day-to-day experience, efficacy, and challenges, contributing to both adherence and meaningful, real-world evidence.

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

At HealthHive, we extend existing clinical trial solutions with our patient data, engagement, communication, and resource platform.

Endnotes

1. Tufts Center for the Study of Drug Development. 2023. Financial and Performance Implications of Decentralized Trials. Tufts CSDD Impact Report. https://csdd.tufts.edu/impact-reports
2. National Institutes of Health (NIH). 2022. “Clinical Trials Dropout Rates and Associated Costs.” NIH.gov. https://www.nih.gov/news-events/news-releases
3. U.S. Food and Drug Administration. 2020. Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. https://www.fda.gov/media/127712/download
4. Tufts Center for the Study of Drug Development. 2023. Financial and Performance Implications of Decentralized Trials. Tufts CSDD Impact Report. https://csdd.tufts.edu/impact-reports
5. Getz, Kenneth A., Rachel A. Campo, and Ashley K. Kucher. 2023. “Evaluating Digital Technology Integration in Decentralized Trials.” Therapeutic Innovation & Regulatory Science 57(3): 213–225. https://doi.org/10.1007/s43441-022-00486-6
6. Deloitte Insights. 2022. Survey on Decentralized Clinical Trials: Adoption and Challenges. https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/decentralized-clinical-trials.html
7. De Brouwer, Walter, Chirag J. Patel, and Arjun K. Manrai. 2021. “Empowering Clinical Research in a Decentralized World.” NPJ Digital Medicine 4(102). https://www.nature.com/articles/s41746-021-00473-w

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