https://www.newswise.com/coronavirus/upmc-leads-global-effort-to-fast-track-testing-of-hydroxychloroquine-and-other-covid-19-therapies-with-learning-while-doing-clinical-trialUPMC Leads Global Effort to Fast Track Testing of Hydroxychloroquine and other COVID-19 Therapies with ‘Learning While Doing’ Clinical TrialNewswise — PITTSBURGH, April 9, 2020 – A novel clinical trial developed by researchers at the University of Pittsburgh School of Medicine launched today at UPMC to address one of the most important debates during the COVID-19 pandemic: How should doctors decide between quickly adopting new therapies, such as the anti-malarial drug hydroxychloroquine, and waiting until they are tested in longer clinical trials?
“The solution is to find an optimal tradeoff between doing something now, such as prescribing a drug off-label, or waiting until traditional clinical trials are complete,†said Derek Angus, M.D., M.P.H., professor and chair, Department of Critical Care Medicine at Pitt and UPMC.. “We’ve developed a way to do that with an adaptive clinical trial model that relies on a type of artificial intelligence known as reinforcement learning to identify the best, evidence-backed therapy for COVID-19 much faster than using the traditional scientific approach.â€
Before COVID-19 emerged, Angus and a wide range of international collaborators had developed a platform, called REMAP-Community Acquired Pneumonia (REMAP-CAP), designed to find optimal treatments for severe pneumonia both in non-pandemic and pandemic settings. When COVID-19 began circulating, REMAP-CAP was rapidly adapted, as per its intent, to incorporate additional treatment regimens specifically targeting the SARS-CoV-2 virus. ...
REMAP (randomized, embedded, multi-factorial, adaptive platform) allows researchers to rapidly test multiple treatment approaches simultaneously at a lower cost and with fewer patients than traditional clinical trials. The REMAP design, first described by Angus in 2015 in the Journal of the American Medical Association (JAMA), is a flexible version of what are called “adaptive platform trials.†“Adaptive platform trials are rapidly being endorsed by the U.S. Food and Drug Administration, the Bill & Melinda Gates Foundation and others as a long-needed revolution in clinical trials,†said Angus ...
The current FDA testing process/model is an attempt to achieve infinitesimally small risk by throwing time, patients, and money at the process. It has a significant place, IMO, but it is very ill-suited to responding swiftly to a pandemic or an incipient outbreak of something new in the US.
