Woodcock Sees Clinical Trials Deteriorating Under Covid
The Covid-19 pandemic has led to a further deterioration in the U.S. clinical trials system, CDER director Janet Woodcock acknowledged 9/29 during a Friends of Cancer Research program. Woodcock, who is currently on detail to Operation Warp Speed, said that once the pandemic emergency is over, the agency will “need to do some serious soul searching.” Woodcock made her assessment after moderator and former FDA commissioner Mark McClellan noted that in other areas of biomedical research there are a lot of people not making it into clinical trials.
Woodcock described the current situation with Covid-19 trials as “starvation in the midst of plenty.” She said there is competition for patients at major medical centers and “yet people are sick and dying all over country and they have no access to clinical trials.” FDA is also concerned that there are a large number of trials not yielding actionable data, with an estimated six percent of current Covid-19 trials yielding actionable data, she said. Either the trials are not randomized and impossible to draw firm conclusions from or they are underpowered (small trials) or under-enrolled. “We need to think about how we can have a more robust standardized process in U.S. for gathering clinical evidence,” Woodcock told the virtual program.
Under Operation Warp Speed, Woodcock says she has been focused on therapeutics, particularly antiviral compounds and monoclonal antibody therapies, which look promising. She pointed to a recent Regeneron announcement on data from a seamless Phase 1/2/3 trial of its investigational antibody cocktail REGN-COV2. The data showed that the therapy “reduced viral load and the time to alleviate symptoms in non-hospitalized patients with Covid-19,” according to the company. It also showed “positive trends” in reducing medical visits.
Woodcock also noted she is working with sponsors and NIH on master protocols as a means to test multiple agents. Master protocols is a pet project with Woodcock, who has been advocating for these for many years. In 2017, she and another FDA official authored a New England Journal of Medicine article, saying the move to such protocols is needed because the “standard approach to generating this evidence — a series of clinical trials, each investigating one or two interventions in a single disease — has become ever more expensive and challenging to execute.”
A master protocol “may involve direct comparisons of competing therapies or be structured to evaluate, in parallel, different therapies relative to their respective controls,” the officials wrote. “Some take advantage of existing infrastructure to capitalize on similarities among trials, whereas others involve setting up a new trial network specific to the master protocol. All require intensive pretrial discussion among sponsors contributing therapies for evaluation and parties involved in the conduct and governance of the trials to ensure that issues surrounding data use, publication rights, and the timing of regulatory submissions are addressed and resolved before the start of the trial.”