Group Devising Lower Cost Clinical Trials

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24 Jan. 2022. A new not-for-profit organization aims to create a more efficient process for large-scale randomized clinical trials, to provide reliable results at lower cost. Protas, founded last year in London, announced a £5 million ($US 6.7 million) grant from Paris-based drug maker Sanofi, to supplement the group’s initial funding from the U.K.’s National Health Service or NHS.

Protas plans to work with industry and academic researchers, health care providers, patient organizations, and medical foundations to design large-scale clinical trials testing new treatments for a wide range of diseases. The organization is developing a collaborative process for clinical trials that includes advances in technology to make trials more efficient and inclusive, while delivering reliable findings.

The work of Protas is based in part on the experience of its founder Martin Landray, professor of population health at University of Oxford, who leads the Randomized Evaluation of Covid-19 Therapy or Recovery trial testing a large number of treatments for people with Covid-19 disease. The Recovery trial is enrolling 50,000 participants in the U.K. and four other countries to test a wide range of drugs to treat Covid-19, from simple aspirin to new synthetic monoclonal antibodies. Among the trial’s findings, says Protas, is the efficacy of dexamethasone, a common inexpensive steroid drug, to treat severe Covid-19 cases.

The organization seeks to deliver clinical trials with a common standards-based information technology platform, while also tailoring its studies to meet specific, scientific, regulatory, and patient-care needs. Protas says trials will be designed for the full process life-cycle of clinical studies from planning and recruitment to delivery of results for sponsors and regulators.

Prospect of fewer treatments in the pipeline

As an example, the Recovery trial uses an adaptive design that allows for adding or removing different treatment candidates or population groups, using a common study protocol and streamlined consent forms. In addition, the Recovery trial, seeks access to patients’ electronic health records for follow-up, as well as conventional in-person or online data collection.

Protas plans to apply lessons learned from the Recovery trial to a broad collection of diseases. “The situation is not
[unique] to the pandemic,” says Landray in a Protas statement. “there are many other common and other life-threatening diseases — for example heart, lung and respiratory disease, arthritis, cancer, depression, and dementia — where better treatments are needed to reduce the huge burden on patients and the NHS.”

But developing new therapies faces increasingly higher costs, thus the need for a new process to better control those costs or the prospect of fewer treatments in the pipeline. Dietmar Berger, chief medical officer at Sanofi, says the need for lower clinical trial costs influenced the company’s decision to become a Protas partner. “With this collaboration,” says Berger, “we are taking a bold [step] to significantly reduce the cost of some of our clinical trials, focusing on what matters the most for patients, doctors, regulators, and payers.”

Protas plans in 2022 to continue building its organization and add partners, with the first clinical trials expected next year.

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