There’s a massive gap in cannabinoid education as it pertains to clinical research, especially as it pertains to subjects enrolling in clinical studies within the medical cannabis industry. It all starts with pre-screening and continues throughout the actual trials themselves. Enabling study coordinators to educate patients and patient advocates properly about the endocannabinoid system, cannabinoids, how cannabinoids interact with certain medications, what impact your medical history might have on your success with cannabinoid-based therapies, and so much more relies on everyone who is a part of the process to have the best education they can possibly receive.
Here are three aspects of the clinical research process that emphasize a growing need for cannabinoid education, especially for those involved in clinical research and moving the needle forward for cannabinoid-based therapeutics.
The Pre-Screening Process
During the pre-screening process, a study coordinator or patient advocate is encouraged to develop a trusting relationship with potential subjects from the moment they first meet and communicate. Clinical studies can be overwhelming for subjects as they are already suffering from a variety of ailments and conditions. By the time they reach the point of exploring clinical trial options, many subjects feel hopeless. Because of this, it is especially important to be clear and informative about what the study they may be potentially enrolling in will entail.
A study coordinator will go through the inclusion and exclusion criteria of the study with the subject and discuss, at a very high level, the subject’s previous diagnoses and current treatment. If the subject meets the inclusion and exclusion criteria, the study coordinator will start to discuss the specifics of the clinical research protocol.
Some of the things that are discussed include:
- The number of clinic visits
- The duration of the clinic visit
- The details of each study visit and what procedures are being performed
- The study drug
This first part of the process can not be misleading by any means. Misinformation, misunderstandings, and miscommunication often stem from not knowing the facts and data. The more study coordinators and their teams know and understand about cannabinoids, the better they will be able to help subjects determine whether or not a study is a good fit for them, and what they can expect from it.
Patients Need to Understand Exactly How Potential Treatments Work
In a cannabinoid-based clinical research study, subjects coming in fresh will typically not understand how cannabinoids, Delta 9, Delta 8, or terpenes work and what their roles are as nutraceuticals. Therefore, study coordinators need to spend a fair amount of time providing education to potential subjects.
Oftentimes, it’s not enough to merely state how cannabinoids work or what they do. It is equally as important to explain the extraction and manufacturing process behind cannabinoid-based products, and cannabinoids and terpenes themselves (if relevant based on a study’s drug).
With the mainstream narrative of cannabis still not being up to par, subjects are oftentimes only aware of smoking or vaping cannabis flower, and aren’t aware of the potential for them to consume capsules, tinctures, or to even place a transdermal patch on their bodies as a delivery method for cannabinoid-based drugs. The study coordinator or patient advocate should also be prepared to explain and answer questions regarding the consumption process for the study drug.
Study Coordinators Need to Be Able to Answer Questions
Study coordinators and patient advocates need to take the proper amount of time to actively listen to what subjects are telling them and what they want to know more about. It is not uncommon for subjects to forget to mention information about previous conditions or hospitalizations that are important to share with the study coordinator. Clinical research teams and patient advocates also need to be prepared to discuss potential drug-drug interactions, the endocannabinoid system, and study-drug method of action within the subject’s body.
Subjects participating in cannabinoid-based clinical research studies are often interested in learning and understanding the specifics. It is the study coordinator or patient advocate’s duty to ensure that their method of communication and education is top notch.
Better Education Means Greater Impact
Recruiting subjects in cannabinoid studies can be challenging and takes more time to pre-screen based on the complexity of cannabinoids. As we perform more clinical research studies, subjects will become more accustomed to cannabinoid clinical research just like mainstream pharmaceuticals or biotechnology. As clinical researchers, it’s critical that when we develop timelines for clinical studies, we include enough time for subject recruitment purposes and proper education, especially with cannabinoid-based therapies being so fresh and new.
Given the current climate of cannabinoid research and drug development, it is critical that all clinical research professionals follow strict guidelines. Data is everything. Enrolling the proper subjects is extremely important to the success of your clinical research study and the quality of life your subjects are hoping to achieve. The basis of all of the above is providing proper education and training from the top down.