COVID-19 should come as a prompt to the clinical research sector to rapidly reinvent itself as it works to design and launch clinical trials for vaccine and therapeutic candidates “in the teeth of the epidemic,” says Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research.
To help move that effort along, the FDA is closely watching COVID-19 trials and will soon put out a guidance on pandemic trial design.
“We don’t have experience, really, of very many completed trials and certainly no successful trials,” says Woodcock. And if the agency tried to issue guidance now, there wouldn’t be much to say.
Woodcock said the FDA currently has 72 agents directed at the virus in active trials, another 211 development programs in the planning stages, with another 950 inquiries and proposals awaiting response.
“This is a massive effort, and although we may not run out of patients unfortunately, we may run out of research personnel and time availability to do this in this way, having separate development programs,” she said during a Clinical Trials Transformation Initi-ative (CTTI) webinar last week.
“This crisis underlies and points out, really, the need to have a better clinical trial infrastructure in place that could rapidly repurpose itself” to suddenly pivot to respond to a pandemic, she said.
Woodcock said she now wants to see the industry shift to conducting more master protocols — trials that examine the safety and efficacy of many agents in parallel rather than the traditional trial that just looks at one drug candidate. For years.
“We think that there is urgent need for master protocols to be put together, particularly for all the repurposed agents that are not going to need a lot of early work,” said Woodcock.
Such a trial looking at early phase COVID-19 vaccine candidates, for example, could allow for the rapid elimination of the less promising agents and the quick selection of the more promising ones to move forward into a more extensive evaluation.
FDA Commissioner Stephen Hahn agrees. He said earlier this month that the agency is interested in developing master protocols, possibly in conjunction with regulatory agencies in other countries.
Woodcock added that the FDA is in a public-private partnership with the National Institutes of Health to develop master protocols and is also working with other groups that are trying to get master protocols underway.
In late March, the World Health Organization proposed a master protocol for companies and institutions that aim to test therapeutics against COVID-19.
Among other changes Woodcock said she’d like to see in the industry as it designs COVID-19 trials: running trial data off electronic health records rather than having separate case report forms. This would be “extremely valuable, particularly with the kind of outbreak this is. We want to minimize contact between people and not subject healthcare personnel to a lot of added steps and procedures.”
“All this comes down fundamentally to metric planning, quality by design, figuring out how to integrate these data collection efforts and procedures into the ordinary workflow,” she said.