Clinical trials are the cornerstone of medical research, providing crucial data to identify valid treatments. The rapidly growing wellness industry needs clinical trials to demonstrate if these non-prescription treatments are effective — if they indeed are, they could offer proven alternatives to pharmaceutical drugs that are more affordable and accessible. But for clinical trials on natural products to provide relevant, generalizable results, they need to be truly representative of the population as a whole.
Large segments of the U.S. population, including women, pregnant people, older adults, rural residents and people of color, have been historically underrepresented in clinical trials — which can have serious implications. Women experience adverse drug reactions at almost double the rate of men, typically from “unanticipated side effects.” That’s not a surprise, as most drugs in use today were originally approved based on clinical trials only conducted on men, a vast majority of whom were white.
In fact, less than half of U.S.-based clinical trials even report on the race of participants in the trials. Of those that do, the vast majority of participants are white, and people of color are represented well below Census levels, contributing to unexpected outcomes such as asthma medication being less effective in Black versus white children and blood thinners leading to more excessive bleeding in Asian versus white patients.
Dr. Jeff Chen, MD, MBA, the CEO and cofounder of Radicle Science, is on a mission to change this paradigm, aiming to make clinical trials truly diverse, inclusive and accessible to all. Radicle Science conducts clinical trials that are 100% remote, allowing populations to participate that are traditionally excluded from clinical trials, which often take place at major university hospitals in metropolitan areas.
“When clinical trials are in a physical location, you have to go in repeatedly to participate,” said Chen. “If you’re a single parent, mobility-impaired, don’t own a car or can’t take time off from work, it would be incredibly inconvenient for you to join the study. We addressed these concerns by going 100% remote and direct to consumer. We ship participants the study product, and we collect all the data from their existing devices, whether a tablet, laptop or phone. If we need something like saliva or stool, we send them easy-to-use self-collection kits that they can mail back to us. It saves them time and allows us to study more diverse populations.”
Another diversity and inclusion challenge in clinical trials is that recruitment is often conducted through healthcare systems, said Chen. If healthcare providers recruit patients who regularly engage with them, then clinical trials are skewed toward certain demographics.
“There are a lot of populations that do not trust or outright fear the medical system,” said Chen. “So for them to learn about a clinical trial from the doctor, that’s a nonstarter because they’re not seeing their doctor. And in addition to the inconvenience for them to go to a clinic or hospital to participate in the clinical trial, the fact that they don’t trust the medical system is also a nonstarter. For example, African Americans have had unethical research conducted on them by doctors in the past.”
Radicle Science recruits broadly using a variety of online advertising, as well as outreach to community groups. Over 20% of the company’s trial participants have been people of color, said Chen, and in most recent studies, this number has grown to 30%. This is compared with 2% to 16% in most clinical trials. And approximately 20% of Radicle volunteers are from rural populations, who don’t have many opportunities to participate in clinical trials. Radicle Science has also achieved gender parity in its studies, with more than 50% of its participants identifying as female at birth.
“We are constantly improving our reach to all these different populations, and then also appealing to them in a way that might be most relevant,” said Chen. “We take into consideration where they’re coming from, what their interests are and what their experience may have been in the past with research or medical care.”
While it might be uncommon for traditional clinical trials, forming long-term relationships with study participants is a goal for Radicle Science, explained Chen. Radicle’s participants frequently volunteer for many clinical trials over time and refer friends and family to participate as well. More than 30,000 volunteers are on waiting lists to join new Radicle studies as they open. Also, unlike traditional clinical trials, Radicle Science doesn’t offer financial incentives, opting instead to give study participants free natural health products, tools to track their usage and outcomes and personalized health reports. In this manner, Radicle aims to work with a new generation of “citizen scientists.”
“We want to make sure that the studies are truly valuable for the volunteers, and not just valuable in the way that it was done in the past, for example giving them some gift cards,” said Chen. “What we want to do is ensure that they can actually improve their health. So we do something that is very atypical for clinical trials, which is as soon as the study completes, we automatically unblind them to what they’ve been taking and show them a summary of their personal data.”
Volunteers are told at the beginning of a study that they can either receive a placebo or the supplement being tested, such as turmeric or the extract of a fruit. When the study concludes, the company tells them which option they actually received during that study and provides a personalized health report summarizing their usage and health outcomes.
“The products in our studies aren’t new synthetic drugs that have never been tested in humans; they’re existing supplements that a teenager could buy from a grocery store,” said Chen. “And so from that perspective, we also make this approach much more familiar, much less scary.”
“Our volunteers are citizen scientists, self-motivated to be in the study to benefit society’s knowledge, as well as their own knowledge of their body,” said Chen. “They most often rank contributing to science as a top motivator, as well as seeing if a certain natural product works for them, and getting data back on what’s happening with them. We want to inspire a diversity of people to participate in clinical research to ensure that the datasets can then be relevant to them and people in their communities and families. And, specifically, equal representation in clinical trials for the wellness space could turn these products into proven treatments that are affordable, don’t require prescriptions or insurance and are known to be effective for broad populations — that’s the power of Radicle inclusion.”