Radicle ACES: Breaking new ground for science and society
by Pelin Thorogood, M. Eng, MBA
Executive Chairwoman & Co-founder
Radicle ACES (Advancing CBD Education & Science) is the largest and most comprehensive randomized controlled trial (RCT) of its kind. The study leverages a virtual, direct to consumer (D2C) approach to collect rigorous health outcome data on thirteen mission-driven U.S. CBD brands.
The Real-World Evidence (RWE) collected with Radicle ACES will inform scientific understanding on dosing, usage patterns, user characteristics, effectiveness across conditions, and predictors and modifiers of treatment response.
Addressing industry challenges head on
The process of testing and researching CBD products is full of challenges which have historically deterred and often prohibited many brands from obtaining validated data on their product safety and effectiveness.
Radicle ACES is designed to overcome these historical barriers and strives to elevate the industry as a whole.
Barrier #1: Research is expensive. Traditional clinical trials designed for FDA approval typically range from millions to tens of millions of dollars per study.
- Solution: Radicle Science priced brand participation in the study at an affordable rate for virtually any brand looking to demonstrate product effectiveness.
Barrier #2: Research is restricted. Most universities receive federal funding and steer clear of studying commercial CBD products because regulatory status at the federal level remains unclear.
- Solution: Radicle Science disrupts the traditional clinical trial model by combining the reach of a market research company, the scientific rigor of a research university, and the agility of a tech company. Radicle Science does not accept federal funding in order to maintain freedom and flexibility in their research.
Barrier #3: Research is slow. Clinical trials can take several years from inception to trial completion, to eventual publication of the results.
- Solution: Radicle’s proprietary data analytics platform offers the first ever path to natural product validation at scale. Leveraging our virtual, direct to consumer approach, Radicle ACES will launch in August 2021 and anonymized aggregate results will be released in October 2021.
Barrier #4: Third party validation. Commercial CBD brands have historically not been studied by independent third parties despite a call for more data.
- Solution: Radicle ACES will be the first and largest randomized controlled trial studying the effectiveness of 13 leading commercial CBD products.
Barrier #5: Lack of data on CBD usage and dosage. The top reasons consumers buy CBD is to alleviate pain, sleep disturbances, or anxiety. The FDA has called for more RWE to support these use cases, and to provide guidance on usage and dosage for consumers and healthcare providers.
- Solution: Radicle ACES is Institutional Review Board (IRB) approved and will capture CBD effectiveness data directly from nearly 3,000 study participants, specifically tracking usage and health outcome data of orally ingested CBD products on well-being, quality of life, pain, sleep disturbance, and anxiety.
Barrier #6: Research is typically done on homogenous populations. Due to the high cost and site-based nature, clinical trials typically only include a limited number of participants from narrow geographies. As a result, the outcomes of these studies often don’t apply to the broader population.
- Solution: Radicle ACES is 100% virtual, allowing for inclusivity and ensuring a highly diverse participant population across a variety of ethnicities, age groups, geographies, behavioral habits, and pre-existing health conditions
What’s next for Radicle Science
Radicle Science will continue to collaborate with high-quality, mission-driven CBD and CPG brands to collect additional RWE on effectiveness of orally ingested CBD products as well as CBD topicals over the coming months.
We support the implementation of best practices from the impact management and ESG space, and look forward to seeing continued development of socially and environmentally conscious initiatives from the thirteen high-quality, leading U.S. CBD brands participating in the study.