If you go into any major grocery or drugstore in the United States and head to the vitamins and supplements aisle, you'll be inundated by a seemingly infinite array of options: pills and capsules, powders, tinctures, sprays, dissolvable strips. These nonprescription health products come in every form imaginable (and some that defy imagination), from countless different brands. None are currently required to conduct clinical trials or seek FDA approval, yet they purport to ameliorate every common ailment: sleeplessness, anxiety, low energy, digestive discomfort, joint pain, poor memory, etc. But what is the reliability or quality of the ingredients in these products? What conditions can they actually treat? What formulation is the optimal, when many are available? For what kind of individuals will they work best — or at all? Is their effectiveness validated beyond anecdotal support?
These are the questions that motivate Dr. Jeff Chen, MD, MBA, the CEO and cofounder of Radicle Science, a pioneering company that is making it much easier for non-pharmaceutical products to prove their true effectiveness.
Generally, only the makers of patented pharmaceutical drugs can afford to pay millions of dollars for traditional clinical trials, which take years to complete. Non-pharmaceutical products like dietary supplements usually cannot be patented and thus can't justify the tremendous expense of clinical trials, resulting in a "proof gap" in the clinical data between prescription drugs and non-pharmaceuticals.
Radicle Science is solving this problem through next-generation clinical trials that generate evidence at a fraction of the cost and time of traditional trials — all while studying larger scale and more diverse populations and conditions. As its name suggests (in botany, the radicle is the first part of the plant to emerge, a root that grows downwards into the soil to anchor the seed), the company offers a new solution — not just cheaper or faster clinical trials, but a new category Radicle Science refers to as "proof-as-a-service."
"Right now, every stakeholder making, selling, buying, or recommending wellness products is often flying blind," Dr. Chen says. "Our studies allow these stakeholders to make some of the first evidence-based health and business decisions on these products. We help a company prove internally, during product development, that they're making the most effective product possible. For products on the market, we help prove effectiveness beyond placebo so they can make validated, clinically proven claims to consumers, healthcare providers, retailers, or potential investors."
Chen explains that the ability to defend these claims with rigorous data generated from gold-standard trials has been missing in the nonprescription health space, hence the proof gap that Radicle Science seeks to address. "The reason a majority of companies in the wellness space don't make strong claims like 'clinically proven' is because they do not have a single clinical trial on their specific product," Dr. Chen says. "They struggle to convince a doctor, a retailer, or an investor why they're different from the thousands of other similar products, and they struggle to convince a consumer that they are effective. So we help them generate proof that they aren't just a placebo."
The trials use a gold-standard double-blind, randomized, placebo-controlled design. In addition, the novel AI-driven, virtual, direct-to-consumer approach not only dramatically reduces costs and improves speed, but also decreases the burden on study volunteers compared to traditional trials. Radicle's study participants are mailed free wellness products and given easy ways to track their usage and outcomes from the comfort of home. In addition, the products they receive have gone through quality and safety review and testing by Radicle, its independent lab partner, and an independent Human Ethics Review Committee (IRB).
Radicle's trials are not the traditional FDA "Investigational New Drug" (IND) clinical trials required of pharmaceuticals because these are dietary supplements and are already commercially available without a prescription. IND trials are not required for supplements nor are they well-suited to the budgets or realities of the wellness industry.
At the end of a Radicle study, volunteers receive personalized health reports so they can understand how the product uniquely affected them, and the brand gets a summary report on how its product performed relative to the control group.
Chen describes Radicle Science's process as having a democratizing effect, which opens access to everyone. "With our crowdsourced method of running clinical trials, we're democratizing access to trials so they're not just available to pharma," he says. "We make clinical trials available to non-pharmaceuticals that need proof and evidence. In the past, they couldn't afford trials — because trials were mainly built for Pharma. What we are doing is supporting the entire lifecycle of these non-pharmaceutical products with proof to develop the most effective products, make strong clinically proven claims, build loyalty with consumers, and build trust among doctors, retailers, and investors."
This democratization also addresses another crucial problem in many traditional clinical trials: a small and overly homogeneous study population. "With larger clinical trials, you're able to incorporate more people and diversity," Dr. Chen says. By delivering the products to study participants' homes and allowing them to use their phone, computer, or tablet to participate virtually, Radicle Science has been able to include far larger and more diverse groups than traditional pharma trials that have strict location requirements and burdensome physical check-ins. "We have people in rural communities participate. We have busy single parents participating, who otherwise can't drive to a clinic every week. If I'm mailing them a product and texting them, it's much easier for participants," Dr. Chen says.
Ultimately, that means the data generated in Radicle Science's trials can be more representative and relevant to the people who actually end up using the product. And that's a big criticism of traditional trials, Dr. Chen says: "Traditionally, clinical trials involved mostly white men living in major metropolitan areas." Chen cites a glaring consequence of male-dominated studies: the fact that 80% of drug recalls are due to women experiencing unanticipated side effects. "And it's no surprise, then, that when a lot of these drugs are used in the real world, they don't perform like they did in the study — because they were studied on only certain types of people."
Though Chen can identify many flaws in the traditional clinical trial process that Radicle Science seeks to address, he pinpoints the need for democratization as the most critical. "It's fundamentally about health equity, too," he says. By removing these barriers, "we're really getting closer to personalized medicine, with products that can't be patented, don't require a prescription, and are accessible by all."
Uncommon Knowledge
Newsweek is committed to challenging conventional wisdom and finding connections in the search for common ground.
Newsweek is committed to challenging conventional wisdom and finding connections in the search for common ground.
