From WSJopinion: Studies are competing for too few patients. It’s time to direct resources toward the most promising therapies, write ScottGottliebMD and Mark McClellan.
By Scott Gottlieb and Mark McClellan Aug. 23, 2020 4:33 pm ET The development of drugs to treat Covid-19 is moving at a remarkable pace. The use of steroids is a major advance that is reducing the risk of death in hospitalized patients. Novel drugs, including manufactured antibodies that mimic the body’s immune response to the virus, are in late-stage development and could be available by the fall. There are about 750 drugs in screening studies or in large, definitive clinical trials .
This “warp speed” approach to vaccine development—a concept that originated with FDA career staff—could be applied to developing other therapeutics. Most of the potentially beneficial treatments are in limited supply, so doctors are forced to ration them. It makes sense to increase clinical trial capacity to include more patients and collect rigorous information on how well these therapies are working.
To reduce some of the uncertainty, we should expand the NIH Covid trial networks by running more large, practical trials like the U.K.’s Recovery Trial. Recovery, an acronym for Randomised Evaluation of Covid-19 Therapy, randomly assigns patients to experimental treatments using a clear protocol. Some of the potential therapies clearly hold more promise than others. The NIH Covid networks have prioritized at least three immune modulators and several monoclonal antibody treatments. But trial capacity is limited and many more compounds are being evaluated only in smaller or nonrandomized trials. This means slower progress on avenues such as anti-inflammatory drugs. Yet trials on drugs with little promise such as hydroxychloroquine were diverting resources from better opportunities.
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