After seven months of clinical investigation, Validcare reported that its team of principal investigators met with members of the U.S. Food and Drug Administration’s Cannabis Product Council (formerly known as the Cannabis Work Group) to share initial findings from the industry-sponsored, decentralized human safety study of hemp-derived CBD products.
This study was commissioned and designed in response to the FDA’s requests, including the agency’s Mar. 5, 2020 report to Congress for science-based data, so FDA can confidently determine the appropriate regulatory path(s) for hemp-derived CBD products. Preliminary findings show no evidence of liver disease in the 839 participants and no increase in the prevalence of elevated liver function tests when compared to a population with a similar incidence of medical conditions.
“Our primary endpoint in this study is to observe potential liver effects in adults ingesting oral forms of hemp-derived CBD for a minimum of 60 days,” said co-investigator Jeff Lombardo PharmD, BCOP. “What we observed to date is no clinical evidence of liver disease in any participants. We observed slight, clinically insignificant elevations of liver function tests in less than 10% of consumers irrespective of age, product composition and form and the amount consumed. Three of the 839 participants had 3x normal levels of the liver enzyme ALT. These three consumers are taking prescription medications that are known to elevate liver enzymes, and we are investigating whether prescribed medications or other factors contribute to these outliers.”
The study’s investigators were surprised to find almost 70% of study participants reported having a medical condition and taking medications for those conditions, without an increase in reporting of adverse events. Studies of similar populations demonstrate an 11% elevation in liver function tests, while this research demonstrated ~9% elevation. “This unexpected, positive finding makes the data even more compelling and provides significant data to consider secondary safety measurements in the general population,” said Keith Aqua, MD, co-principal investigator of this IRB-approved study.
“We are encouraged by these findings and hopeful this study provides FDA with sufficient science-based data to determine and take action on a safe regulatory path forward,” said Aqua. “We will continue to analyze these real-world data and are adding a second cohort to this study to increase statistical certainty for liver safety and secondary measures across diverse populations and consumers with various medical conditions.”
Principal investigators met with FDA on Mar. 15 and reviewed preliminary liver safety study results in the form of an abstract. The parties also discussed establishing a direct communication feed to FDA so it can receive raw, blinded, aggregate data for its analysis.
Twelve companies led the industry in this initial study cohort: Asterra Labs, Care by Design, CBDistillery, CBD American Shaman, Charlotte’s Web, Columbia Care, Global Widget, HempFusion, Infinite CBD, Kannaway, Medterra CBD, and SunMed CBD.
Each brand provided funding, product, certificates of authenticity, and assisted with the recruitment of adult U.S.-based consumers. A minimum of 681 participants were needed to achieve the desired statistical significance. Over 830 consumers completed the study between August 2020 and February 2021. The use of Validcare’s decentralized clinical research platform and partnership with national laboratories enabled participants and principal investigators to successfully complete this first cohort, despite the pandemic, and compile and deliver results to brands and FDA within six weeks.
Congressional leadership asked ValidCare almost 18 months ago to engage the industry to help collect safety data for FDA. “We understand the significance, importance, and immediate need for CBD safety research for the FDA, industry, and the U.S. consumer. This first-of-its-kind, industry-led, multi-branded study required trust, collaboration, operational excellence, innovation, and resilience. It demonstrates the incredible potential for decentralized clinical research to increase participant access and accelerate results—even during the most challenging times,” said Patrick McCarthy, CEO of Validcare. “We are excited for our principal investigators to continue, expand and report out on this foundational work in the next few months. Once completed, the safety results of this study will be shared with participating brands and FDA. The investigators also plan to publish in a peer-reviewed journal.”
