Using Cannabis Clinics for Medical Cannabis Trial Recruitment
The age-old problem and one of the biggest hurdles in clinical trials is recruitment. It’s the ultimate rate limiting step which can significantly impact clinical development timelines. As any sponsor of a clinical trial can attest to the most demanding stages of any clinical trial is the recruitment phase.
There are several factors which impact the recruitment rate of a clinical trial, these can range from the rarity of the disease in the population right through to the sheer willingness of the institution driving recruitment. From the outset it should be understood that any clinical trial will contain a primary objective or an outcome it is hoping to achieve. Most certainly these objectives are tied to a therapeutic and its effect on a disease. Sometimes the disease is common and the available patient population is vast, such as diabetes. Other times the disease is rare, such as Haemophilia, with significantly reduced the absolute number of patients.
Common diseases more often than not will have a wide range of approved therapies available to medical practitioners for the treatment of patients. In such cases, patient sentiment towards being part of a clinical trial is a foremost hurdle to recruitment. More and more clinical trial sites will face the “guinea pig” mindset instilling negative connotations towards participating in the trial of an unproven therapy with unknown side-effects.
Conversely, in cases where it is a rare disease there will be a lower absolute number in the patient pool. Likewise big pharma once traditionally avoided developing treatments for such diseases due to a lack of economic viability. Although in recent years this sentiment has shifted towards actively targeting rare diseases because of the limited available therapies. Having limited number therapies, as many companies have realised, increases the likelihood of monopolizing treatment (if an effective therapy can be developed). Patient sentiment towards these types of trials is also unique in that patients are desperate for improved treatment resulting in an increased willingness to participate.
Access to patients is paramount to successfully achieving recruitment milestones in a clinical trial. The ability to reach patients, or prospective subjects of a clinical trial is a key indicator during feasibility assessments of a clinical trial site. For example, after discussing the protocol with a prospective Principal Investigator (PI), they are first asked about the absolute number of patients at their site. Then they are asked about how many of these patients would fit the inclusion criteria and finally how many they believe would be willing to try the therapy and participate in the proposed clinical trial.
Sponsors will go to great lengths to achieve recruitment milestones. Some will turn to advertising through various mediums such as TV, Radio, Newspapers and social media. Such strategies are non-specific and can lead to non-specific or wasteful returns on investment. Other sponsors will target major hospitals or clinics for their trial sites as these can have a wide catchment area of potential subjects. Some have employed pharmacy sales data of competitor drugs as a way of identifying key geographical areas with the most concentrated patient populations.
Although there are endless amounts of strategies that Sponsors employ to improve trial recruitment, none of these strategies can overcome the hurdle of patient sentiment towards trying an unproven therapy. By definition of the TGA, medicinal cannabis falls under the umbrella of unproven therapies and therefore can only be accessed through special access schemes set out by the TGA. Medical practitioners are not encouraged to use medicinal cannabis but rather to first exhaust other approved therapies listed on the ARTG.
One such pathway set out by the TGA, is through clinical trials under the supervision of medical practitioners. In Australia, the medicinal cannabis industry is still in its infancy stages, therefore recruitment of and access to prospective patients is difficult. Currently no major hospitals have departments specialised in prescribing medicinal cannabis. Thus sponsors will find it increasingly difficult to employ the traditional strategies for recruitment and access to willing patients may be non-existent.
With the demand for credible patient data ever increasing, there is a need to identify unifying geographical areas which can be easily targeted in the absence of major metropolitan hospitals. Such places exist in the form of cannabis clinics.
Cannabis clinics are specialised clinics with streamlined processes in place to improve patient access to medicinal cannabis. These clinics will employ medical practitioners (specialists and general practitioners) who will specialise in the diagnosis and prescription of medicinal cannabis according the TGA regulations for unproven therapies. In some cases these clinics will also be set up to dispense medicinal cannabis to the patient. They are effectively a one-stop-shop for all things cannabis related.
Such cannabis clinics facilitate enhanced trial recruitment by overcoming many of the hurdles as stated earlier. Applying a typical pre-trial feasibility assessment for a cannabis clinic will help to tease out some of the advantages of using cannabis clinics over traditional clinical trial sites.
Firstly the clinic will have very high number of registered patients who could be considered as prospective subjects. Secondly the site will have a range of diseases currently being treated with medicinal cannabis as the clinics themselves are not disease specific but rather cannabis specific. Finally but most importantly as this represents one of the greatest hurdles to trial recruitment, is the patient willingness to participate in a trial of an unproven therapy. In this case, patients are already using the “unproven” medicinal cannabis therapy so participating in a trial typically adds no additional burden or cost from a patient perspective.
The opportunities for R&D in the medicinal cannabis space are extensive, given the amount of unknowns in this relatively new sector of medicine. Working with cannabis clinics to execute a medicinal cannabis R&D program is a way to ensure seamless and rapid recruitment to trials, something that is key in a new and rapidly growing industry with a high degree of innovation and change.