Britain’s RECOVERY trial, a platform study evaluating several potential treatments for Covid-19 using the NHS network of hospitals, has proven to be one of the most successful pandemic attempts, possibly economy hundreds of thousands of lives. Its creators want to tackle other diseases in the same way, and they got money from Big Pharma to get started.
Led by RECOVERY mastermind Martin Landray, the nonprofit Protas was launched on Monday with $6.8 million from Sanofi. The goal is to design and develop large-scale, cost-effective clinical trials across a wide range of diseases, in partnership with pharmaceutical companies, clinical sites, academic institutions and patient groups.
“As we have seen during the recent pandemic, large randomized clinical trials are essential for the proper evaluation of possible treatments,” Landray said in a statement. “The situation is not [unique] to the pandemic; there are many other common and life-threatening diseases…for which better treatments are needed to reduce the huge burden on patients and the NHS.
In addition to the Sanofi partnership, Protas has also won an NHS grant for an undisclosed amount. The nonprofit plans to begin designing its first trials in 2023.
RECOVERY is widely credited with discovering how dexamethasone, a cheap corticosteroid, can reduce the risk of death in hospitalized Covid-19 patients. Landray and his team delivered the result at the start of the pandemic, launching the study in March 2020, giving hospitals a tool to tackle the most severe cases of Covid-19.
The trial also showed that the monoclonal antibody Regeneron/Sanofi and the rheumatoid arthritis drug Actemra worked in the same patients, while finding other treatments like hydroxychloroquine and convalescent plasma were not effective.
Given the inflated costs of conducting clinical studies, Protas now wants to expand the methodology to other common disease areas – its launch statement lists heart, lung and respiratory diseases, arthritis, cancer, depression and dementia as areas of focus. Landray and his team plan to design their own studies from scratch, focusing on the most essential aspects of clinical trials.
Some pharmaceutical companies may even spend hundreds of millions of dollars on a single drug candidate, but Protas hopes its efforts to streamline R&D will allow more drugs to be developed at a fraction of their current costs. And working as a nonprofit will both make education more affordable and improve its quality, Protas says.
Making platform studies the norm is an idea that has already been floated, in particular by Landray himself. In a February 2020 item in NEJM, Landray wrote how pharmaceutical companies were increasingly turning to real-world evidence to cut costs, relying on this “myth” rather than randomized studies.
But by focusing only on the essentials, Protas hopes to turn the tide and remind the industry of the “magic” of randomization.