I consider myself living proof of the American dream. In 1888, my great, great grandfather purchased a farm, Coleman Crest, that is still in our family today. Understanding his story and what he had to overcome during that period in history has given me such a great foundation and what still inspires me today.
My passion for chemistry began when I was a child. At a young age, I was diagnosed with a chronic illness and when things got tough, it was my pharmacist who gave me hope and inspired me to explore the world of science. Soon after, my parents were asked to participate in a medical study for an indication that affected millions of people around the world. In the end, their participation helped bring new medicines and technology that would later eradicate the condition.
I’ve seen first-hand how health inequities and disparities plague our healthcare system. Minorities and people of color (POC) are significantly under-represented in clinical trials. Existing social dynamics and belief structures prevent many under-represented groups from participating even when given the chance.
We have a moral and scientific obligation to expand access so that clinical research can benefit all people in a much more equitable way. Never has this been more apparent than during the COVID-19 pandemic, which has dramatically and disproportionately affected minorities and POC. Despite calls to ensure diverse patient populations are enrolled in COVID-19 treatment and vaccine trials, minority participation in these studies has not been robust, and targeted outreach efforts to recruit diverse patient populations have been slow to launch.
Given the clear disparities in disease outcomes in different subpopulations, it is a scientific necessity to develop novel therapeutics and vaccines with all groups sufficiently represented. Testing therapies in populations with no regard to race, ethnicity, socioeconomic background, gender, or age, can clearly lead to critical gaps in understanding a product before it reaches the broader marketplace.
Decentralized clinical trials (DCTs) have the potential to address a lot of these issues. DCTs, at their core, are trials that do not place the traditional “brick and mortar” academic or clinical site at their center but build study components around the patient in their home, thus “decentralizing” the research process.
Here are some ways DCTs have the potential to improve participation rates across traditionally difficult-to-enroll populations.
1. Breaking Down Historical Barriers to Create Trust
It’s no surprise that minority groups do not trust the system. Historical events like slavery, Tuskegee, Puerto Rican birth control experiments, and the exploitation of Henrietta Lacks have provided lasting and justified reasons for distrust in scientific institutions. The attitude of “I don’t want to be a guinea pig in anybody’s experiment” is difficult to reverse.
The scientific community has seen firsthand the levels of trust and comfort that result when participants can talk with someone from their own demographic. The DCT model enables physicians from anywhere to conduct research remotely, which allows studies to employ investigators with more diverse backgrounds. This approach connects patients with people they believe better understand their perspective when it comes to their trust (or lack thereof) in the research enterprise.
2. Making Trials More Accessible to Increase Participation
It is no small commitment to take part in a clinical trial. Participation requires patients to spend a significant amount of time (and often money) on traveling to a clinical site, interacting with busy study staff, and completing the many tasks and activities outlined in the protocol.
These burdens often equate to insurmountable hurdles that prevent people from participating, particularly those from lower socioeconomic backgrounds, that tend to have hourly wage jobs. Most are unable to take days off from work, or hand off childcare responsibilities, or leave their homes according to a site’s schedule. Participation can be impossible for some, even when there may be strong motivating factors for a person to enroll in a study, such as access to an otherwise unavailable treatment.
A significant benefit of DCTs is that they remove or reduce some of these barriers to entry. One critical obstacle is the need to regularly visit a study site. It is estimated that up to 70% of the U.S. population lives over 2 hours driving distance from a large academic research institution. Even if one lives near a site, lack of easy or affordable transportation can make commuting a challenge, particularly when dealing with a health issue.
An important element of most visits that take place in the home is technology. Remote participants typically use a smartphone or tablet-based applications to communicate with study staff, fill out digital study questionnaires, and stay up-to-date on other study-related tasks. One of the major goals of DCTs is to democratize access for all people, therefore, it is critical to ensure that the technological tools implemented do not prevent certain groups from participating.
3. Leveraging Direct-to-Patient Recruitment Strategies
A basic lack of awareness of trial opportunities is another factor that contributes to the limited participation of minorities and POC. Because DCTs are not centered around individual sites, they allow for unique recruitment strategies outside of traditional site-based methods. These include direct-to-patient approaches such as social media outreach through Facebook and Instagram, search engine advertisements, community websites and more traditional channels like radio, TV or locally-based efforts. Fully remote clinical trials can recruit people regardless of where they live making it advantageous to cast a very wide net to generate initial interest in a study.
DCTs may not solve all challenges in diversifying clinical trials but they do offer unique opportunities to improve participation rates among groups that have historically been absent. We all have a responsibility to patients, science, and society at large to make genuine efforts at building trials that are more inclusive and readily accessible for all people. The existing barriers may be challenging to overcome, but doing so is possible, worthwhile, and imperative.
About Ryan Pack
Ryan Pack heads up the Diversity in Clinical Research Foundation and the Science 37 global business unit that relates directly to the company’s mission of improving diverse representation in clinical trials. She came to Science 37 after working with Contract Research Organizations (CRO): PRA Health Sciences, PPD, and Worldwide Clinical Trials. At the CROS, she was actively engaged in clinical operations, business development, and most recently a strategic commercial leadership role.
Ryan also has 15+ years’ experience driving diversity & high priority initiatives across academia, grassroots community organizations, clinical industry task forces: Association of Clinical Research Organizations (ACRO) and Center for Information and Study on Clinical Research Participation (CISCRP) and collaborating with patient advocacy organizations such as International Children’s Advocacy Network.