Problems and Opportunities with Cannabis Research. The Opportunity for Real World Data

This is an article I created and originally posted on my personal LinkedIn as well as MoreBetter’s site. It’s here with permission from me. :)

Something that most already know: Traditional research in the cannabinoid space is a difficult endeavor.

By traditional we mean the double-blinded, placebo controlled, clinical trial that goes through Phase 1, 2, 3, etc... Very few cannabinoid based products have gone through this process. Access to the plant for research is an obvious challenge given its Schedule 1 narcotic status.

There’s also the cost to do this level of research. According to Statista, the cost of a new drug can be around $2.6B, AND take 15 years. Very few brands have that capital (and time).

Big pharma hasn’t done many cannabinoid studies at scale given its Schedule 1 status. A few have. But not many.

So how can the cannabis industry do quality research when the “traditional” methods have such high barriers?

Since COVID the importance and relevance of Real World Data has become more recognized. In some cases, even prioritized. This presents an opportunity for the cannabinoid industry.

In my opinion, there's a much bigger opportunity with Real World Data. Making health, wellness, and medicine more people and need focus, rather than financially driven. But that's a topic for a different article.

Millions of individuals are regularly consuming cannabinoid products. There’s an opportunity to engage with these individuals, in a remote setting, and collect Real World Data on product use and performance that can actually be used for research and regulatory evaluation purposes.

At MoreBetter, we’ve been collecting Real World Data on cannabinoids since 2016.

To date, we have 13 studies published in different medical journals and ongoing prospective studies with a global network of academic research partners (called our BetterTogether Learning Community).

We lower the barrier to collect and understand Real World Data.

We've learned over the years you can do quality research with Real World Data if structured and collected the right way.

This is not the same as collecting survey responses and/or product reviews. That’s what most who are not educated on Real World Data think.

One of the most important aspects with collecting Real World Data is making sure it’s longitudinal. In other words, collected over time, and not in a one-off instance (like review).

Most times, you are relying on participant reported outcomes. So, it’s also important to make sure your study is designed properly. A best practice we learned from our BetterTogether Learning Community is using the right validated questionnaires. This increases data integrity so the data may be used for research and regulatory evaluation purposes.

Here’s two charts that show Real World Data we collected to measure change in quality of life and sleep disturbance before vs during cannabinoid use. We used the validated questionnaires: WHO-5 and PROMIS Sleep 8b.

A validated questionnaire may not always be available, or appropriate, for all questions. When this happens you still want to make sure you’re following best research practices. As an example, the chart below shows how we used a 0-10 Likert scale question to monitor daily change over time, before and during cannabinoid use. This time focusing on appetite levels.

What’s often missed, or not considered, when collecting Real World Data is filling in the data gaps.

In this article from MM+M, Amy Abernethy, President of Product Development and Chief Medical Officer at Verily and a former Deputy Commissioner at the Food and Drug Administration (FDA), offers a technique called data linkage to help solve for this problem. As described in the article, data linkage consists of combining multiple data sets to fill in the gaps that may exist between data sets.

Thankfully, with where technology is at today, there's a lot that can be accomplished here with a good API.

To be clear, Real World Data has its limitations. And, there are benefits with traditional research.

However, traditional research is not always accessible or realistic. Especially with products used outside the standard/traditional medicine and healthcare system. That shouldn’t mean research and data collection should cease to exist.

Real World Data is being used in research and regulatory evaluation settings. It's also a valuable asset for designing better protocols for clinical studies.

It's also being used in marketing and more commercial settings.

Over the past few years we started to see more professionals and brands come to the realization of the value that can come from collecting Real World Data the right way.

The ways Real World Data can be utilized, when collected the right way, are endless. This article provides some great examples on the use and benefits of Real World Data.

To offer a few examples from groups we work with:

1. CBDistillery has been collecting Real World Data on a wide range of their products for the past few years. Some of which they’ve highlighted here.

2. Slumber Sleep Aid™ recently worked with us and The Cannigma to become one of the first brands to have Real World Data on the use of THCv and CBG for appetite suppressant.

3. FOCL collected a compelling dataset on their uniquely formulated sleep product.

4. Miyabe Shields, PhD and Riley D. Kirk, PhD are actively organizing their community to collect Real World Data on an ongoing basis to better understand the effects and impact of regular cannabinoid use. This is/will likely be one of the largest datasets of its kind.

What’s exciting is these are all examples of cannabinoid research being done. It might not be research by the definition most are familiar with. But it is research. AND, these brands and individuals now have more Real World Data on their products, customers, and/or community than 99% of others in this space.

This doesn't just apply to cannabinoid based products. The same opportunity is true for other categories such as natural supplements, nutraceuticals, vitamins, functional mushrooms, or any other type of functional wellness product. Again, it's really anything that falls outside of the standard/traditional medicine and healthcare system.

If I had to pick between waiting for traditional research, or doing research now by collecting and analyzing Real World Data, I’d pick the latter. Obviously that’s my completely (un)biased opinion. :)

As I mentioned above, this is the result of many learnings over the past couple of years. These learnings come from great partners and collaborators in our BetterTogether Learning Community, advisors, mentors, and other partners.

This is how we believe it should be. A collaborative effort.

So, in the spirit of collaboration. What research learnings do you have? What research opportunities do you see? Or, what are you seeing in the research space that you think is interesting? Or needed