Decentralized Clinical Trials (DCT): A Path to Health Equity
Decentralized Clinical Trials: A Path to Health Equity
In June, the U.S. Food and Drug Administration issued revised guidance on Diversity Action Plans. These plans aim to boost clinical study enrollment of historically underrepresented populations to enhance the data the agency receives about potential medical product users.
Traditional clinical trials, often held at major medical centers, have faced criticism for their lack of diversity. Barriers such as travel, time constraints, and limited awareness disproportionately affect individuals in rural areas and underrepresented groups.
In today’s highly digitized healthcare environment, many trials already incorporate decentralized elements. This shift means that several aspects of clinical research are moved from traditional clinical sites to participants' homes or nearby locations. Decentralized clinical trials (DCTs) leverage technology to enhance accessibility, including:
Telehealth: Virtual consultations, assessments, and follow-ups with healthcare professionals.
Wearable Devices: Real-time tracking of health metrics like activity levels, heart rate, and sleep patterns.
Mobile Apps: Collecting patient-reported outcomes, administering surveys, and providing educational resources.
Direct-to-Patient Drug Delivery: Shipping medications directly to participants' homes.
The study "Advancing Clinical Trial Equity Through Integration of Telehealth and Decentralized Treatment" explores how integrating telehealth and decentralized methods can significantly improve clinical trial equity. It highlights that such integration leads to increased access, enhanced participation, better engagement, and operational efficiency, ultimately advancing health outcomes across diverse patient groups.
How Can DCTs Increase Health Equity?
The World Health Organization (WHO) defines health equity as the absence of unfair, avoidable, or remediable differences in health among population groups defined socially, economically, demographically, or geographically. (Source: WHO). Studies have highlighted disparities in access to interventions, such as home dialysis or transplants for patients with end-stage CKD.
In specific diseases, outcome disparities often stem from genetic and environmental factors. For instance, in the U.S., societal drivers play a major role in type 2 diabetes, disproportionately affecting minorities. Factors like socioeconomic status (SES), residential segregation, educational attainment, and support for disease self-management contribute to dramatically unfavorable outcomes.
Social determinants of health, including socioeconomic status, race, and ethnicity, create barriers to basic medical care and prevent minority groups from participating in clinical trials. Decentralized trials help bridge this gap by providing access to research and improving our understanding of how environmental factors influence health outcomes.
DCTs enhance trial recruitment and retention by offering flexibility and reducing reliance on traditional research facilities. They allow participants to engage in trials regardless of their location, addressing the cost and time burdens of traveling to trial sites. This flexibility fosters greater diversity in enrollment.
The Future of Clinical Trials
The healthcare industry is on the cusp of a value-based care revolution, with AI as a key driver of this new era. Collaboration among researchers, payers, providers, and innovators is crucial. Intentionality and goal-setting are essential for shaping research initiatives. Studies aimed at addressing representation gaps should be designed with specificity to support these goals, while research focused on effectiveness or reactions should ensure that the participant pool reflects the demographics of the affected population.
Incorporating decentralized elements into trials can enhance representativeness by reaching communities previously sidelined and reducing the overall participation burden. Investigator teams must clearly communicate the value of research to participants and acknowledge how this value may vary across different communities.
Decentralized clinical trials are more than a trend—they represent the future of research. Advances in technology enable new mechanisms for executing research, expanding reach, decentralizing, and increasing flexibility. By breaking down barriers and improving accessibility, DCTs are a powerful tool for advancing health equity and enhancing the lives of millions.