American Clinical Research Needs to Step Up Its Game Against Covid-19
Using its authority to approve treatments for emergency use, the Food and Drug Administration recently allowed convalescent plasma for hospitalized Covid-19 patients. But because the large 35,000-person study on the treatment lacked true randomization and placebos, we don’t really know if antibody-rich plasma actually improves mortality.
In fact, both Francis Collins, the director of the National Institutes of Health, and Anthony Fauci, the government’s top infectious disease expert, raised concerns that emerging data on the treatment was not strong enough to merit emergency approval.
Convalescent plasma illustrates more than a problem with the F.D.A.’s approval process. It points to a larger shortcoming in clinical research in the United States.
Americans and American biomedical researchers have often prided themselves on conducting the best clinical research in the world. Yet with over six million Covid-19 cases and almost 183,00 …continued .
[Source: New York Times]