The new guidance from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) stating that the use of real-world data from clinical trials could help with quicker regulatory approval for new medicines is welcome news for the psychedelic industry.
The new guidance from the MHRA has outlined how the use of real-world data for clinical trials could help with quicker regulatory approval for new medicines and improve clinical trial recruitment.
The announcement follows consultation with pharmaceutical industry stakeholders, patient organisations, trade associations and academic researchers, among others.
Commenting on the new guidance, MHRA Chief Executive, Dr June Raine, said that real-world data can “make a huge difference when it comes to bringing medicines through clinical trials to patients.”
Currently, the UK’s gold standard method of assessing medicines for regulatory approval is randomised controlled trials (RCTs). This method is considered the most scientifically rigorous as it utilises placebo groups, large sample sizes and double-blinding.
The method, however, can have its limitations as not only is it extremely costly (sometimes costing millions of pounds), but the stringent controls in these trials do not always reflect the real world.
For psychedelic medicines, using real world data as an addition to RTCs would allow for reduced costs and quicker access to medicines for patients.
Leading psychedelic researchers, including Dr Robin Carhart-Harris, professor David Nutt and Dr David Erritzoe, et al, earlier this year pointed out that supplementing RTCs with real-world data and digital health solutions could “better support the discovery of optimal and personalised treatment protocols and parameters.”
With real-world data, data sets are routinely collected from patients through electronic patient health records, and disease and patient registries. This kind of data is used to monitor medicine and medical device safety, however, it is rarely used to demonstrate the effectiveness of a medical intervention before it is approved.
Most recently, one instance when real-world evidence has been utilised for a new medical intervention is for COVID-19 vaccines. As vaccine trials usually take years to complete, including real-world data can help assess efficacy much quicker.
As noted by the British Medical Journal: “Well conducted real world studies of vaccine effectiveness are an important complement to randomized controlled trials.”
With the current mental health crisis, there is a desperate need for quick access to new and effective medicines for patients with resistant conditions, and a number of psychedelics have shown promise in this area.
The new guidance has been welcomed by UK psychedelics companies, including Albert Labs, a member of Psychedelic Health’s editorial board, which is developing psilocybin medicine to treat cancer-related distress.
CEO, Graeme McFarlane, commented: “The new guidance from MHRA in respect of the value Real World Evidence brings clinically to the regulators accelerated access strategy for patients is welcome news and underscores the approach Albert Labs is taking as a leading psychedelic manufacturer, fully supported by the UK regulatory authorities in the acceleration of clinical development in areas of both unmet need and importance to UK public health.”
Non-profit drug reform organisation, Drug Science, which has been carrying out Europe’s largest patient registry for medical cannabis, Project Twenty 21, and which is campaigning for the rescheduling of psilocybin for research purposes, has also welcomed the news.
David Badcock, chief executive of Drug Science, commented: “When one considers the obstacles that prevent researchers from conducting safe, large scale trials, it becomes clear why Real World Data is so valuable.
“Our own Project Twenty 21 uses exactly this kind of data. It’s one of the largest observational studies of its kind in the world. And it indicates the real world effectiveness of medicinal cannabis for improving patients general health and quality of life.
“That’s why Drug Science believes the MHRA’s guidance is a welcome step in the right direction. There is still much more to do here, but our hope is it will lead to increased acceptance of important evidence.”
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