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PsyCap Special Report: Clinical Trials & RWEs in the Psychedelic Industry

The post PsyCap Special Report: Clinical Trials & RWEs in the Psychedelic Industry appeared first on Microdose Psychedelic Insights.



As psychedelic medicine makes its bold re-emergence into modern medicine, the role of clinical trials and real-world evidence (RWE) is pivotal to the progress of this movement. Much like the biotech and pharmaceutical industry, money is following efficacy when it comes to psychedelics, and the drugs are showing incredible promise (once again) in recent clinical research. The role of real-world evidence (RWE) or real-world data (RWD) can significantly enhance the design of robust clinical trials and novel drugs in psychedelic medicine. This month’s Psychedelic Capital conference series explores this topic of the impact of RWEs in clinical trials in an open discussion panel featuring top experts in the space.

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The Role of Real World Evidence (RWEs) & Real-World Data (RWD) in Psychedelic Medicine

The most advanced drug and biotech companies make pivotal R&D decisions based on real-world data (RWD) and real-world evidence (RWE). The difference between the two has been described as RWD being “data as is” whereas RWE is using RWD as clinical evidence. Through this vital information, the effects on efficacy, toxicity, and cost of care can be better analyzed. For the emerging psychedelic drug market, this is critical given the novelty of the sector and the amount that is still unknown. From therapeutic index and establishing the best modality of care, to minimizing toxicity and adverse reactions in a new generation of psychedelic drugs, RWD and RWEs are sure to play an important role in the evolution of the industry. Indeed, the FDA identifies both the relevance and importance of RWD when evaluating RWE.

RWD/RWE Can Reduce “Out of Pocket” Costs for Drug Developers, Increasing Patient Access

Another important factor RWD/RWE plays in drug development, and thus, psychedelic drug development is its impact on overall out-of-pocket costs for drug companies. In fact, the term “financial toxicity” is used to describe how rising drug development costs ultimately raise drug prices, preventing patient access to necessary medication. The utilization and intelligent interpretation of RWD/RWE information are projected to lower drug prices and expand overall access to this important, new generation of medications.

RWE Can Enrich and Possibly Even Replace Some Clinical Trial Efforts

Despite the thorough and arduous nature of clinical trials, they are not perfect representations of entire patient populations and demographics. Certain “real world” data cannot be obtained from clinical trials due to the strict inclusion/exclusion criteria and the fact this leads to many patients with common comorbidities not being studied. In the “real world,” these patients often end up getting treated with the aforementioned therapy, and this data matters to drug companies. Finally, most doctors and clinicians participating in clinical trials tend to specialists. The ability for more generally practicing clinicians to treat a wider range of patients is an important and valuable experience for the medical community at large.

Other Dramatic Ways RWEs Will Impact the Psychedelic Drug Development Sector

In oncology, prior to the 21st Century Cures Act, the primary role of RWEs was to assess toxicity through the real-world reporting of adverse effects. Today, this field utilizes RWE to construct a “ synthetic control arm” that was ultimately used for the FDA approval for two cancer drugs. Clearly, there is enormous value in harnessing RWE as they can, among many things, enrich drug trials and provide a deeper, more applicable understanding of how certain drugs and treatments affect larger, more diverse populations along with the world at large. The psychedelics space is likely to follow suit with traditional pharma, with everything from drug toxicity (it should be noted most psychedelics are generally non-toxic) to optimizing clinical trials with “synthetic control arms”, RWE is likely to play an impactful role in psychedelic science and research in these ways.

psychedelic capital special report

Advanced Algorithms and Artificial Intelligence is Going to Radically Change the Game

RWD and RWE will also facilitate the creation and evolution of advanced computer algorithms that will allow for more robust cohort matching when designing clinical trials. For instance, a group of patients taking a group of similar drugs or treatment modalities can be compared and the subset of patients who most benefit from a certain therapeutic intervention within a group of similar drugs or treatments can be identified. That is to say, if a group of patients are all receiving psychedelic-assisted therapy for depression and the data shows that psilocybin-assisted psychotherapy benefits a certain subset of patients the most over other treatments, this can be easily and quickly identified.

When companies share this scientific data in peer-reviewed journals and reports, it allows for scientists and researchers across the industry to learn from and utilize this data to guide their own efforts. Consequently, this information will turn around and help enhance these algorithms even further. AI is rapidly being incorporated into the workflow of a variety of psychedelic companies.

Robust Digital Therapeutics, Such As iSTRYM, Poised to Revolutionize Psychedelic Therapy

Along with the development of novel new drugs in the emerging psychedelic space are some uniquely versatile and powerful digital tools poised to revolutionize psychedelic medicine and psychedelic-assisted therapy by integrating RWD/RWE into their analyses. In turn, tools like iSTRYM, being developed by Mindcure, will help provide healing at scale and benefit both therapists and patients alike. We had the pleasure of connecting with Kelsey Ramsden, Mind Cure Health Inc. President and CEO about the value of RWE in psychedelic science and how iSTRYM will facilitate that.

“I believe that RWE data capture is a tremendous opportunity in the psychedelics industry as there are many people practicing and implementing care modalities utilizing psychedelics around the globe and across many medicines. Powered by iSTRYM, this data can be translated into meaningful and actionable insights for therapists and clients or patients. These outcomes can help us identify what we should drive into the lab for proof as well as arm those practicing today with the data to drive better outcomes through quantified medicine and personalization at scale. We are proud to be at the forefront of the biometric and psychometric design that will take RWE and give it science rooted meaning.”

~Kelsey Ramsden, Mind Cure Health Inc. President & CEO

From Speak AI voice to text capability that will allow patients to capture profound insights they experience during psychedelic-assisted journeys to biometric data and intuitive music manipulation, the iSTRYM app contains many features to help therapists do their art while patients experience their healing, and the iSTRYM app does everything in between. Essentially, this powerful integration of technology into psychedelics will eventually allow for deeper insights and faster progress in the field as a whole. Other notable companies in the space creating innovative digital therapeutics include Field Trip Health, EHave, Osmind, ATAI Life Sciences, and MindMed, just to name a few.

Closing Thoughts & A Look Ahead Into Clinical Trials and RWE in Psychedelic Medicine

The impact of real-world data and evidence can be crucial to the success of any developing sector in the biotech and pharmaceutical sector. Psychedelic medicine has, in many ways, many parallels to both. The strong clinical drive to medicalize these compounds through a rigorous, evidence-based approach, will greatly benefit from collecting and analyzing real-world data and evidence to further optimize clinical trials, drug design, and therapeutic modalities for this exciting, promising new field of medicine.

Get your FREE ticket to the Psychedelic Capital: The leading due diligence conference and the gold standard for investment information in the emerging psychedelic space

The post PsyCap Special Report: Clinical Trials & RWEs in the Psychedelic Industry appeared first on Microdose Psychedelic Insights.

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