Is the UK an ideal location to run psychedelic trials?
Article updated on 20/12/2021 to reflect updated Government policy on real-world evidence.
The UK Government, in their determination to attract investment and talent to post-Brexit Britain, have announced the fastest increase in R&D spending ever. By playing a more enabling role, the government wants to make the UK a science and innovation powerhouse as part of their revival strategy post-Brexit and -COVID-19.
This creates a historic opportunity for the UK to unleash psychedelic science as the government commits to reforming the clinical trial system and considers the rescheduling of psilocybin.
The rate at which the UK approved the Oxford-AstraZeneca vaccine and made decisions surrounding the procurement and rollout of other vaccines proved what is possible in the acceleration of drug development. This case highlighted the significance of the speed and processes for clinical trials and laid the foundations of a more enabling regulatory framework.
As set out in The Future of UK Clinical Research Delivery: 2021 to 2022 Implementation Plan, the UK hopes to facilitate the set-up of studies in record time to restore the UK’s global leadership in clinical trials. This is relevant to companies looking to launch drugs outside the UK as well since clinical data generated in the UK is applicable globally. The UK wants to set the pace for innovation by developing forward-looking clinical trial frameworks. Psychedelic research will also benefit from this, paving the way for the UK to become a global leader in psychedelic clinical trials.
Having left the EU Single Market, the UK is using its regulatory sovereignty to develop this more globally competitive and compelling framework.
The government has already undertaken tangible steps, one of which has been the introduction of the Innovative Licensing and Access Pathway (ILAP). ILAP is similar to the FDA’s fast-track designation in the US and reduces the time to market innovative medicines. Within five months of the very first ILAP designation, Small Pharma was granted an Innovation Passport for DMT-Assisted Therapy for Major Depressive Disorder, demonstrating the spillover benefits and potential opportunities these clinical trial reforms can bring to psychedelic research in the UK.
While the UK regulators’ provision of an Innovation Passport to a psychedelic trial proves the shift towards a more enabling regulatory environment for psychedelic research, the bar for designation is set quite high. Demonstrating how a drug and indication can meet the criteria for ILAP can be quite challenging, especially in psychedelics where the data is nascent, and where there is still so much to learn about how the drugs produce their benefits. Identifying the right indication and treatment group is a process that Clerkenwell Health has conducted for drug developers, ensuring the best chance of gaining accelerated market access.
MHRA Headquarters, London. The decision to fast-track drugs is made by the MHRA who work alongside the Department of Health and NICE.
MHRA's new guidance on using real-world data to support clinical trials will also help get psychedelic treatments to patients sooner, and cheaper. Vast amounts of data are already collected from patients within the healthcare system from electronic health records to patient registries. These data, which are used to monitor safety after drug approval, will now be considered to demonstrate the effectiveness of treatments before approval. This is important because being able to use real-world data will reduce logistical burdens around patient follow-up after the delivery of psychedelic treatment. And it will allow, once approved, the repurposing of psychedelic treatments for new conditions, making trials much more cost-effective.
Innovative study designs have never been so necessary in mental healthcare due to issues with blinding in psychedelic trials and high costs associated with the delivery of quality talking therapies. The good news is that reforms will now take place in this area. The UK regulators are working on increasing their understanding of the barriers to innovative approaches. They want to support researchers to design and deliver their studies in more innovative ways through detailed guidance, expert advice, evaluation and showcasing the delivery of such approaches in practice.
As regulatory barriers to research are under scrutiny, the conversation around the rescheduling of psilocybin is becoming mainstream as well. Under the current scheduling, a Home Office licence is necessary to lawfully possess and prescribe psilocybin for research. This licence is costly and slow to obtain, and therefore, the reclassification of psilocybin under Schedule 2 would greatly reduce the time and costs associated with psychedelic research. It is not clear when such a change will take place, but when it does, the UK will be an even more attractive location to run psychedelic trials.
The coming years will see constantly evolving regulatory and operational changes and Clerkenwell Health can assist drug developers in navigating these novel, complex but rewarding frameworks.
With a dominant share of the small psychedelic specialty talent pool alongside leading clinical trial experts, Clerkenwell Health is also prepared to pioneer the use of innovative research designs to increase both the efficacy and efficiency of psychedelic trials.
The competitiveness of trials depends on the whole clinical trial system. While an enabling regulatory environment is necessary for psychedelics, it is not sufficient to make a system ideal for conducting clinical trials. An effective psychedelic trial system should be able to identify and recruit patients in a timely manner, have sufficient site and therapist capacity, capture quality data and have efficient infrastructures in place for data collation.
The heritage of psychedelic research in the UK allows the building blocks of an effective system to be more readily available to drug developers.
Recruiting participants for clinical trials is easier than traditional pharmaceuticals as there is more awareness of psychedelic medicine with individuals and relevant organisations such as patient groups and charities. Although more trained therapists are needed for delivering psychedelic-assisted therapy, the UK has a relatively high number of experienced therapists, and opportunities for training. To help support the ecosystem as a whole, Clerkenwell Health is working with a number of global therapy experts to build a pool of trained experts able to support trial participants.
Clerkenwell Health supports the psychedelic clinical trial system in the UK in a number of ways. By offering the only specialist clinical research support for psychedelics in Europe and providing drug developers a one-stop-shop for all stages of research, Clerkenwell Health further adds to the UK as an attractive destination to carry out clinical trials.
With its focus on creating data network pools by utilising innovative digital technologies to engage and support patients, Clerkenwell Health will improve the efficiency of trials. The upcoming Centre of Excellence by Clerkenwell Health will also offer a unique space designed specifically for the delivery of psychedelic therapies.
In summary:
The clinical trial system in the UK as well as the broader innovation system is being transformed to attract clinical trial investment.
The regulator is being reformed to become an enabler of innovation, the psychedelic clinical trial system is becoming more effective, and the movement to reschedule psilocybin is gaining traction.
Drug developers should make use of these opportunities for a speedier and more cost-effective research process as the UK provides an increasingly frictionless pathway to the timely availability of psychedelic treatments.
