{"id":42863,"date":"2022-01-24T11:47:12","date_gmt":"2022-01-24T16:47:12","guid":{"rendered":"https:\/\/sciencebusiness.technewslit.com\/?p=42863"},"modified":"2022-01-24T11:47:12","modified_gmt":"2022-01-24T16:47:12","slug":"group-devising-lower-cost-clinical-trials","status":"publish","type":"post","link":"https:\/\/technewslit.com\/sciencebusiness\/?p=42863","title":{"rendered":"Group Devising Lower Cost Clinical Trials"},"content":{"rendered":"
\"Doctor<\/a>
(Rawpixel, Unsplash)<\/figcaption><\/figure>\n

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<\/a>, founded last year in London, announced a \u00a35 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.<\/p>\n

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

The work of Protas is based in part on the experience of its founder Martin Landray<\/a>, professor of population health at University of Oxford, who leads the Randomized Evaluation of Covid-19 Therapy or Recovery trial<\/a> testing a large number of treatments for people with Covid-19 disease. The Recovery trial is enrolling 50,000 participants<\/a> 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>, a common inexpensive steroid drug, to treat severe Covid-19 cases.<\/p>\n

The organization seeks to deliver clinical trials with a common standards-based information technology platform<\/a>, 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.<\/p>\n

Prospect of fewer treatments in the pipeline<\/h4>\n

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<\/a> 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.<\/p>\n

Protas plans to apply lessons learned from the Recovery trial to a broad collection of diseases. “The situation is not
\n[unique] to the pandemic,” says Landray in a Protas statement<\/a>. “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.”<\/p>\n

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<\/a>, 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.”<\/p>\n

Protas plans in 2022 to continue building its organization and add partners, with the first clinical trials expected next year.<\/p>\n

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