If you missed the Council for Federal Cannabis Regulation webinar: Understanding Real World Evidence on the Effectiveness of Cannabinoid Products

…Here’s a quick recap. On Thursday we had an interesting and lively conversation with hosts Sarah Chase, Executive Director of CFCR, and Jack Jacobson, Advisor for CFCR and for Thompson Coburn, LLP. The two hosts asked some great questions, which Radicle Co-founders Pelin Thorogood and Dr. Jeff Chen, along with Tim Orr, SVP of R&D at Charlotte’s Web Labs answered.

On RWE and consumer confidence in CBD products

In the absence of clinical trials, how is this real world evidence really helping build consumer confidence in CBD products? —Jack Jacobson

“These are clinical trials that we’re running. We’re just running them in a virtual, decentralized fashion, which has happened to a significant amount of the trial landscape ever since the COVID pandemic. For instance, for the [Radicle] ACES study… 3000 people were recruited and screened… and then they were randomized to receive one of 13 different types of CBD products, as well as randomized to a control arm. And then we tracked them using validated outcome measures… developed by the National Institutes of Health to track real world outcomes reported by the participants in a naturalistic setting like their own homes.” —Dr. Jeff Chen

On use of isolates in clinical studies for better predictability

"Since pharma requires an API status, which would mean the use of the isolates versus the whole plant, should growers or the industry be moving forward with the use of isolates for better predictability?" —Sarah Chase

“We’ve demonstrated that with good stable genetics and GMP manufacturing processes and good quality control you can maintain a high level of consistency and reproducibility… for botanical drug development. You don’t have to do just isolates to pursue a botanical drug pathway.” —Tim Orr

“What’s nice about a botanical drug pathway is… you’re allowed to have many different ingredients or active compounds in the botanical extract. You don’t even need to know which one’s necessarily responsible for effectiveness. You just have to demonstrate that this one is effective and safe.” —Dr. Jeff Chen

On truthful self-reported dosing and usage In RWS

"How are you and your studies determining dosage and usage and then, including an audience member's question: 'What about instances of misreporting for at home dosing?'" —Jack Jacobson

“We incentivize them by not dollars and cents, which is a typical clinical trial outcome, but by giving them their data back to show them how does this product actually help you across these indices… So they’re incentivized to tell us the truth, because the data is something they’re going to be able to use personally… It’s something they can take to their doctor say, ‘I’ve been taking the CBD and this is how it helped me sleep’….” —Pelin Thorogood

“Traditional trials, especially ones that are site-based, oftentimes tell people to keep a medication journal… and that’s basically the record of their usage, but you have no idea if they’re sitting in the parking lot filling out the last week or so because they don’t want to be judged when there’s a lot of blank entries. Whereas, when we collect things in real time, virtually, from people directly, we can prove it came from their devices. And the last thing I’ll say is, in our studies, you can analyze the data two different ways: you can look at the intention to treat analysis, which is basically just the serving size suggestion on the label product and then we’ll also look at the actual reported dosages as well to see what additional things that can inform us.” —Dr. Jeff Chen

On toxicology and safety with ingredients and dosage

"What have we learned from some of the toxicology reports that are out there?" —Sarah Chase

“The dosing is linked to intended use… and it starts with dosing with studies for toxicity and safety first—normally you do that before you put it in human—and then it’s dosing for general wellness and dosing for efficacy, which is very specific condition based, the latter two of which Jeff and Pelin are doing and contributing a body of data to this field. From a toxicity and safe use standpoint, really every manufacturer in this space needs to go through the requisite toxicology studies to ensure that they’re using and recommending dosing levels that are well below toxicity levels to ensure safe use, and that is normally done with a panel of experts that would review that data to stamp it as generally recognized as safe. And that should be done before any human studies are done and I’d recommend every manufacturer go and do that” —Tim Orr

On big data and AI in precision medicine

Closing thoughts?

Because we have this massive data set… versus your traditional [dataset, which includes] maybe dozens, maybe one hundred people, we also have the opportunity to use machine learning in the form of artificial intelligence to be able to dive into the data to look for hidden correlations… With Radicle Science, in addition to studying how these products may affect the public, which is very important from epidemiological or public health perspective, we’re also trying to get to precision medicine, to really understand how different people based on demographics and behaviors may actually need different doses or different types of products. That’s another area we’re going into and the size of our dataset and the heterogeneity of our dataset actually enables us to go there, which is very exciting. —Pelin Thorogood

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