Some argue that the dearth of studies conducted on healthy populations makes it very difficult to generalise about the benefits of CBD outside those groups with diagnosed medical conditions. Meanwhile, the debate about real-world evidence (RWE) as opposed to controlled human trials rumbles on. Brown at OBX points out that the library of clinical evidence around CBD is growing, with university-level research complementing what EIHA is doing with toxicology testing in Europe, for example. She admits, though, that large-scale clinical trials can be too costly for small-to-medium size enterprises (SMEs) to afford and can take years to plan and execute.
Consumers are turning to CBD for myriad reasons, but the market and regulatory status require different thinking by brands
“But building this body of evidence is going to be critical to the category, including validating RWE with clinical data,” says Brown. OBX itself uses the services of Radicle Science in California, she explains, which offers research platforms for home usage trials. These can be used to substantiate, for example, US structure/function claims for dietary supplements. Canadian-headquartered contract research organisation (CRO) Nutrasource confirms that CBD, like other active ingredients, has seen a shift away from traditional clinical trial templates during the pandemic. Instead, there has been a focus on “mobile app-based, decentralised trials”, says senior VP strategic solutions Rodney Butt. “These have emphasised observational or post-approval type trials, rather than indication-specific research using defined CBD products,” he adds. The issue of dosage rears its head here, too, in Butt’s point about “defined CBD products.” Different trials will have been carried out with varying doses of CBD. Additionally, this CBD may be derived from different sources (hemp-derived, whole plant extract, biosynthetic or fully synthetic) and target a range of end-uses, he cautions. In some cases, this may be misleading. “It is possible that consumers mistakenly assume that evidence from controlled research with pharmaceutical-grade cannabinoid therapeutics, such as Epidiolex, applies to all retail CBD products,” Butt explains, by way of an example. As well as the “lack of standardisation in the administered product,” Nutrasource identifies research challenges in the very breadth of CBD’s therapeutic potential, but also in the “pronounced placebo effect,” given the “expected efficacy” in many consumers’ minds in relation to cannabinoids. “A deeper understanding of the limitations of current research programmes must be stated, and new assessment methodologies must be investigated before we can move forward to clarify the efficacy and safety of CBD,” he argues. CBD-Intel makes the point that ‘defined products’ have tended to mean CBD isolates, where variables are minimised and a clearer link can be demonstrated between cause and effect. “But if brands would like to make health claims about any sort of spectrum products (and there is definitely appetite for that), then there will need to be some way to design a study that can account for the greater complexity and lack of understanding about the interaction of the wider array of cannabinoid and related compounds,” says Dawson. In the meantime, most target health claims for CBD are notably difficult to demonstrate. While anti-inflammatory potential might be empirically measured, says CBD-Intel, what about anxiety, stress, or even pain?
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