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Betting on Better Drug Trials to Beat Covid-19

Scott Gottlieb, M.D.
 

By Scott Gottlieb and Mark McClellan (original source Wall Street Journal)

“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 (Phase II) or in large, definitive clinical trials (Phase III).

The challenge is to develop evidence as quickly as possible without compromising standards. Anytime there’s an unmet medical need, the tendency is to blame the Food and Drug Administration’s regulatory process. But if we don’t know what works, and what doesn’t, we’ll waste time and money on treatments that won’t help and may harm. Even if a vaccine is discovered and approved, the pandemic won’t end unless most Americans get vaccinated, which will require confidence in the product’s safety and efficacy.

The FDA has been using its expertise to help drugmakers develop evidence faster. The agency has issued 60 guidance and other documents for Covid, giving detailed advice on how to speed up development. Thanks to the FDA’s guidance, large, well-designed vaccine trials are underway and moving at an unprecedented pace. Moderna and Pfizer’s vaccine programs have enrolled more than 25,000 patients in four weeks. (One of us, Dr. Gottlieb, serves on the board of Pfizer.)

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.”

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