What Is a Decentralized Clinical Trial? What BIPOC Patients Should Know
Clinical trial policies and goals have been topics of interest for us at Diverse Health Hub (DHH), and we wanted to take a look at decentralized clinical trials (DCTs). After the COVID-19 pandemic brought virtual healthcare methods, DCTs emerged as an option for patients to aid in the study for improved treatments and other research. Decentralized clinical trials offer many advantages over traditional clinical trial models, but what are DCTs exactly? Here’s a look at clinical trials and Black, Indigenous, and People of Color (BIPOC) patients, DCTs, and what decentralized clinical trials can mean for BIPOC patients.
BIPOC Underrepresentation in Clinical Trials
Adequate representation of BIPOC patients in clinical trials for improved treatments, vaccines, and other medical research has been a long-time challenge due to a mix of factors. Compared to their white counterparts, BIPOC patients have fallen short of their U.S. Census population percentages in clinical trials. Health equity advocates have cited factors including travel and time off work required for clinical trials and a history of mistrust due to past breaches of trust like the Tuskegee syphilis experiment among other reasons.
Decentralized Clinical Trial Methods
While traditional clinical trial designs required patients to travel to large medical centers to participate, this is no longer the case with decentralized clinical trials that take advantage of some remote healthcare options. DCTs allow patients to participate in studies with new designs that often include options that ease previous barriers to clinical trial access. Previously underserved patients may be able to take advantage of multiple clinical trial methods including telemedicine visits via computer, tablet, smartphone, or telephone; patient visits at their home, wearable medical devices; patient web portals; drug delivery directly to the patient home; locally based lab tests; and sensory-based technologies.
Decentralized Clinical Trial Pros and Cons
Looking at the positive and negative impacts of decentralized clinical trials, analysis shows a mix of things taking place. Due to less travel required and overhead expenses of carrying out studies, decentralized clinical trials are shown to have lower expenses to carry out their research. Higher treatment compliance and patient monitoring that is both more accurate and more often in DCTs lead to improved study accuracy. When the need to make study adjustments arises, decentralized clinical trials are easier to adjust versus their centralized counterparts. And with the convenience and lower costs of joining DCTs, increased diversity in the patients under study – and thus more accurate study findings for a wider variety of patients are discovered.
Some challenges have arisen with the multiple changes in clinical trials designs with DCTs. With various methods of treatment delivery, there is sometimes risk with on-time delivery to patients, and temperature and other package conditions must be maintained to ensure optimal treatment effectiveness. Patient privacy is another concern with decentralized clinical trials, and patients and researchers must work together to help ensure patient privacy. Blockchain technology has proven helpful in DCT data management by enabling the sharing of information among two or more involved parties. Even though technology advancements aid in many aspects of decentralized clinical trials, technologies like wearable devices may still require more clinical validation, technical support, battery life, and improved Internet access before they can be more fully adopted in DCTs. Maintaining patient engagement through remote participation and locating qualified healthcare professionals to perform home-based procedures have also been noted as challenges in decentralized clinical trials. Fortunately, identifying these challenges has set those involved in clinical trial design on the road to correcting the challenges.
Solutions for Improved Clinical Trials and BIPOC Representation
With continued improvements, decentralized clinical trials are a valuable tool to help bridge the gap in clinical trial participation rates for BIPOC patients. Some ways that patient advocates and clinical trial designs can continue improvements for DCTs and clinical trials in general include:
Recruiting clinical trial participants in community settings like churches and barbershops
Offering flexible clinical trial check-ins via phone, tablet, computer, or smartphone
Using blockchain technology for sharing of clinical trial data among two or more parties
Building databases of skilled and trusted healthcare professionals to carry out home-based procedures for clinical trials
Offering clinical trial information in multiple languages for those with limited English language proficiency
Using BIPOC health professionals to recruit more BIPOC patients at recruiting events
Tracking of changing quality and regulatory clinical trial standards
Ensuring clinical trials are safe regardless of the study location
Recent clinical trial design changes in decentralized clinical trials have improved participation by some BIPOC patient groups. But if patient advocates and clinical trial professionals bind together, more improvements can be made to further efforts toward health equity for all patients. Stay tuned as we continue to provide updates about clinical trial diversity and work toward equitable care for all.
Sources
Gail A. Van Norman, MD. Decentralized Clinical Trials. National Library of Medicine website. Accessed July 13, 2022. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8093545/
Jennifer Duff and Jessica Schell. Decentralized Clinical Trials Are Driving Speed and Engagement. Merative website. Accessed July 13, 2022. https://www.ibm.com/blogs/watson-health/decentralized-clinical-trials-driving-speed-and-engagment/
Michele P. Andrasik, Gail B. Broder, Stephaun E. Wallace, Richa Chaturvedi, Nelson L. Michael, Sally Bock, Chris Beyrer, Linda Oseso, Jasmin Aina, Jonathan Lucas, David R. Wilson, James G. Kublin, George A. Mensah. Increasing Black, Indigenous and People of Color Participation in Clinical Trials Through Community Engagement and Recruitment Goal Establishment. PLOS website. Accessed July 13, 2022. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258858
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