Albert Labs has highlighted that the UK’s new guidance on Real-World data will accelerate access to psychedelic treatments.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently confirmed that it would be updating its guidance on the use of Real-World data. It stated that the use of this data from clinical trials would help toward regulatory approval for new medicines at a faster pace.
Albert Labs, which is accelerating access to psychedelic-based medicines for patients with urgent and unmet needs, has said that this new guidance is consistent with its strategy. The company is one of the first psychedelic drug development companies to use a Real World Evidence (RWE) approach for regulatory approval.
Dr Malcolm Barratt-Johnson, Albert Labs CMO, commented: “We embrace this regulatory guidance particularly in the investigation of psilocybin-assisted psychotherapy.
“Albert Labs consider that carefully designed pragmatic trials that implement a progressive use of Real-World evidence, will greatly advance the understanding of the safety, effectiveness, impact, and optimal clinical use of this new therapy.”
Albert Labs is pursuing the Real-World Data pathway in the licensing of their natural psilocybin medicine, which has been endorsed by leading hospital centres in the UK.
This expedited pathway offered by the UK regulatory system will accelerate access to treatment, benefiting patients, not only in the UK but the rest of Europe, Canada and the US.
The guidance emphasises that a study or studies considered under this guidance need to be of the same standard as would be expected from a traditional Randomised Control Trial (RCT), and further states that well-designed and conducted prospective RCTs provide a high level of evidence irrespective of the categorisation of the data source.
“Our approach, in the investigation of psilocybin-assisted therapy, has been designed to reduce risk, improve outcomes, and importantly to speed up access to those patients who will benefit from this therapy,” added Barratt-Johnson.
“We believe Real World Evidence will play a vital role in helping safeguard the development of this promising mental health treatment.”
Albert Labs says is following the MHRA’s guidance and taking the necessary regulatory and scientific steps required for authorisation of a new treatment using an RWE approach.
The trials are focused on early access to treatment and the company expects to treat patients suffering from cancer-related distress in the first half of 2022.
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