Randomized clinical trials are the cornerstone for evidence-based medicine and, as such, are designed to be pragmatic and collect data representative of the larger patient population for the disease profile. Yet, the demographics of participants in clinical trials are generally skewed in comparison to any given population. The US Food and Drug Administration (FDA) reports that only 5% of clinical trial participants are Black, fewer than 2% are Asian, and fewer than 1% are Latino.1 In addition, a lack of representation is also seen with women and seniors.

For years, disparities between the demographics of clinical trial participants and the ethnic diversity of the general patient population have been noted as an area requiring greater attention, planning, and commitment in research. One obstacle to ensuring “meaningful representation” is the logistical set-up of clinical trials. Traditionally, large research institutions, often in urban centers, have been targets for site selection, resulting in underrepresentation of participants from marginalized communities due to lack of awareness, opportunity, and accessibility.

The COVID-19 pandemic has significantly highlighted the disparities that exist in healthcare and amplified the dialog that virtual engagement will narrow the diversity gaps in both patient care and clinical research. The acknowledgement and acceptance of the shift to virtual medicine reinvigorated leaders, healthcare professionals, and health authorities, to leverage technological advancements to drive long overdue changes in clinical trial design.

Decentralized clinical trials (DCTs) have the potential to revolutionize access to clinical trials, leading to improved data outcomes that reflect real-world patient populations.

Taking steps to increase racial and ethnic diversity in clinical trials

Recent guidance published by the FDA states that “ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health”.2 This draft guidance is currently being reviewed and adopted by pharmaceutical companies committed to racial and ethnic diversity and moves away from traditional approaches that lack inclusivity.

DCTs provide the opportunity for Sponsors to expand their patient pools by bringing trials and trial conduct closer to participants, removing logistical barriers, and leveraging technology. In the same way, decentralized clinical trials “remove so many burdens that stand in the way of recruiting patients for trials.”3

Modifying trials to fit the lives of participants, and not the other way around

Traditional trial design often requires participants to be flexible and accommodating to meet the needs of the trial. For many underrepresented populations within a lower socioeconomic status, this level of flexibility is non-existent and becomes a barrier to participation. DCTs combat this antiquated approach by supporting and facilitating home visits, coordinating assessments and blood draws at local laboratories, and providing direct delivery of study drugs and materials to patients’ homes.

A common barrier to trial participation is where the patient lives relative to the study site. Participants in studies must often travel long distances and dedicate a significant part of their day for even short clinic visits. This added burden is enough to discourage participation and makes retention difficult.

During the pandemic, extending clinic hours, broadening the distribution of sites, and using mobile and telehealth options played a major role in keeping participants enrolled in clinical studies. These accommodations removed logistical hurdles and enabled participants who did not live close to research institutions or who lived in marginalized communities to have access to trials on terms that suited their lives.

DCTs have been coined as “direct-to-participant trials”4 because the study design includes accommodations to fit trials into the daily lives of participants with little to no disruption to their regular schedules.

Leveraging technology to push the boundaries of research and reduce burden for all

DCTs are heavily reliant on technology, leveraging virtual tools such as telemedicine, sensory-based technology, wearable medical devices, and patient-driving virtual healthcare interfaces. These tools allow data collection without the need for an intermediary, with the potential to lessen the opportunity for unconscious bias when administering scales or assessments such as quality of life and functional status.4

Using virtual tools, a key component of DCTs, allows data to be sent directly from the participant to the study’s secure database, removing the need for an in-person study visit and manual data entry by site staff. Not only does this reduce the burden to participants and site staff, but it also bolsters timely data collection, data completion, and overall data integrity by reducing the need for touch points with the potential for human error leading to Sponsor queries.

The double-edged sword of DCTs

Although decentralizing trials may address several problems (as noted), they can also cause unexpected new challenges. These challenges may include logistics for study drug shipment, management, and storage, the investment requirements in technology as well as the need for measures to mitigate issues with patient privacy.

Despite efforts to reduce barriers to communication with the integration of technology, DCT designs are also unlikely to replace the benefits and need for face-to-face interactions, which are characteristic of traditional centralized trials.

To mitigate potential challenges with DCTs, it is critical to carefully consider the patient journey and how the demands of the study will impact them. During the planning phase of a DCT obtaining insights from thought leaders, patient advocacy groups, community representatives, and site personnel (Investigators and Study Coordinators) is an inclusive way to identify the greatest needs of study participants. In so doing, Sponsors can use this direction to inform where and how best to incorporate DCT methodology to make a trial more accessible to a broader group of individuals.

Reflecting the needs of diverse patient populations and ensuring they are enrolled in clinical studies, is an important factor in obtaining the necessary data needed to move investigational products to market. The pandemic has accelerated the adoption of DCTs, which has the potential to address some of the challenges that make equitable enrollment difficult with more traditional centralized clinical trials. Although it may be tempting to stick with the status quo and conduct trials centrally, the world of healthcare and research is at a turning point and there is an exciting opportunity to revolutionize the clinical trial landscape. The real question is: are Sponsors ready to ride this technological wave into a new era for clinical trials?


  1. Applied Clinical Trials. Diversity in Clinical Trials: Path to Achieving Health Equity. Available from: https://www.appliedclinicaltrialsonline.com/view/diversity-in-clinical-trials-path-to-achieving-health-equity. Accessed 18 May 2022.
  2. US Food and Drug Administration. FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials. Available from: https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-increase-racial-and-ethnic-diversity-clinical-trials. Accessed 18 May 2022.
  3. Applied Clinical Trials. Digital Therapeutics and Decentralized Trials: A Match Made in Clinical. Available from: https://www.appliedclinicaltrialsonline.com/view/digital-therapeutics-and-decentralized-trials-a-match-made-in-clinical. Accessed 18 May 2022.
  4. Van Norman GA. Decentralized Clinical Trials: The Future of Medical Product Development?. JACC Basic Transl Sci 2021;6:384–387.