But even though the “RCT” – a randomized con

But even though the “RCT” – a randomized controlled clinical trial – is widely recognized as the gold standard, many researchers, Dr. Fauci said, are uneasy at the prospect of giving a placebo in a study, even if it is an existing treatment. Is doing so a betrayal of their oath to “do no harm?”


New clinical trial designs are speeding the drug approval process.
Fortunately, a novel clinical trial strategy, called an adaptive design, may help speed the drug approval process. Dr. Kalil describes it in his Viewpoint. It allows a clinical trial to test more than one treatment. That’s what the National Institutes of Health is doing in a trial of Remdesivir, which has been much talked about and is already through phase 2 to treat HIV/AIDS. It is an intravenous infusion.

The phase 3 trial of Remdesivir is enrolling 440 patients with COVID-19 at 75 sites, and will use the inactive ingredients as the control. But if and when the drug shows efficacy, it can be moved to the control arm and a new candidate drug added to the evaluation protocol. The trial began February 21 and is slated to run until April 1, 2023.

Wrote Dr. Kalil, “This unprecedented speed from concept to implementation in just a few weeks is noteworthy and provides proof that clinical trials can be promptly initiated even in the middle of a pandemic.”