The psychedelic industry needs data. But what data, and why?
Analytics have revolutionised healthcare by helping organisations understand what drives quality, cost and outcomes as well as providing real-world evidence on treatments in addition to what comes out of clinical trials. Now is the time for the psychedelic industry to be driven by data, not just produced by clinicians and researchers but by patients themselves.
Why is data important for the psychedelic industry?
If psychedelic drugs have a chance of being part of mainstream healthcare then it needs to be proven that psychedelic-assisted therapy works better than existing treatments. This not only requires filling gaps in the current body of research but also puts pressure on the psychedelic industry to show better cost-to-benefit ratios.
Although research has shown promising results for psychedelic therapies across a range of mental health conditions, including their potential to work better than common antidepressants, many questions remain unanswered. For instance, it is still not clear which talking therapy model is most suitable, how many therapy sessions are needed for different conditions, how much time is ideal between sessions, what sort of music, if any, should be played during the session or to what extent the therapist should interfere with the patient during the psychedelic experience.
Personal accounts of people suffering from decades of treatment-resistant depression or trauma report finally finding relief, acceptance and connection in life after psychedelic-assisted therapy. However, psychedelic science still cannot tell what conditions and factors enable psychedelics to have a more profound effect on patients nor how to identify people who are likely to respond well to psychedelics.
Since psychedelic drugs allow patients to confront the underlying issues of their mental health condition, it is crucial to understand the links between the aetiology of these conditions and the nature of psychedelic-assisted therapy that is most suitable for that condition. Collecting, integrating and analysing large quantities of data generated by various stakeholders can provide the insights needed to answer all of these questions.
Effective data collection and analysis strategies will optimise innovation in the psychedelic industry and help build new tools for stakeholders including therapists, patients, and regulators. Specifically, well thought through data initiatives could accelerate drug discovery, increase the efficacy of treatments, allow drug developers to better target specific patient populations, and improve the management of risk and safety.
What sort of data does the psychedelic industry need?
Large quantities of data are already generated by drug developers, clinical researchers and therapists through randomised controlled trials. However, these data are not necessarily linked and integrated well due to most pharmaceutical R&D being a secretive activity with little collaboration with external stakeholders. This fragmented approach to data collection prevents the aggregation and comparison of data and leads to duplication of efforts, which in turn slows down the advancement of the field. Therefore, developing consistent and comparable clinical data to identify a clear set of principles and practices on which psychedelic-assisted therapy can be based is currently one of the most pressing needs of the industry.
More data is also needed to respond to the pressure of proving that psychedelic-assisted therapy has a better cost-to-benefit ratio compared to existing treatments. For this, the psychedelic industry needs to show that these therapies have a greater impact on patients’ day-to-day lives through real-world outcomes that matter most to patients. A combination of real-world, observational studies in combinations with randomised controlled trials may be beneficial to demonstrate this.
Patients can now contribute to data collection as clinical endpoints can be captured via smart devices to gather real-world data not previously available to researchers. Additionally, participants of clinical trials can be monitored remotely and over longer periods of time giving rise to great opportunities to gather meaningful data.
The effect of psychedelic drugs is impacted by set and setting far more than any other drug in the market. Real-world studies generating real-world data can shine a light on the differences in outcomes when psychedelics are administered to people from marginalised cultures and economic status enabling cross-cultural validation of clinical results. All this data can be used to analyse drug efficacy in different contexts and for different subgroups as well as facilitating the R&D processes.
It should be recognised that data-driven approaches to psychedelic research raise ethical and legal implications. Companies using patient data, particularly in new therapy areas like psychedelics, with attached stigmas and reputational risks, need to uphold the highest standards of ethical data storage and use. We’ll be looking into the challenges facing a data-driven psychedelic industry in the next blog.
What next?
Integrating data relevant to patient’s background, clinical trial processes and long-term clinical endpoints will accelerate the optimisation of psychedelic-assisted therapy. Sharing and utilising these data will ultimately help organisations develop effective and approved treatments more quickly.
Collaborations between organisations and external stakeholders such as CROs can expand capabilities and insights on clinical trials as well as establishing privileged access to real-time data produced by these stakeholders. By creating data networks to collect, analyse and share real-world outcomes, organisations can broaden their data beyond clinical trials.
