DIA Annual Meeting: Ex-FDA Head Suggests Ways to Enhance COVID-19 Research, Prepare for Future Challenges

Regulators, drugmakers and researchers need to work in parallel to speed development of COVID-19 vaccines and treatments and prepare for the hurdles still to come, a former FDA commissioner advised.

Speaking during the Drug Information Association (DIA)’s annual conference, former FDA commissioner and director of the Duke-Margolis Center for Health Policy Mark McClellan said research, manufacturing and regulatory processes must run alongside each other, and he said action is needed to speed up clinical testing and to ensure supplies of promising therapeutics can meet demand.

To speed up the research process for COVID-19 products, he recommended using large clinical trial networks. He cited the GUSTO trials of the 1980s, a large global study of myocardial infarction that led to much faster insights due to the size of the study.

Through a large study “you can get some very important evidence out much more quickly,” he said. “We’ve known for a while that clinical trial networks are more likely to get studies done quickly and definitively than individual centers operating on their own.”

He also recommended other steps to boost trial effectiveness and capacity, such as developing COVID-19 master protocols, publishing the protocols to encourage wide use and transparency, sharing nonproprietary data using common data models to guide further studies and for use as control populations, and using expanded access programs to collect patient and outcome data.

Additionally, he recommended building on existing common data models and electronic data networks so that there’s additional evidence ready when a product is approved or granted an emergency use authorization.

“We’ve got better real-world evidence systems than ever before and the makings of networks in the U.S. and elsewhere that could potentially develop data from routine electronic data systems,” he said. “It could really augment what we know in clinical trials.”

McClellan called for regulatory agencies to create a “clear pathway” that extends “all the way to widespread access, to help product developers plan effectively and execute quickly,” and that identifies therapeutic candidates early to enable additional support, especially for smaller companies that may have less access to resources.

Regulatory agencies — especially the FDA — should provide more guidance on phase 2 and 3 vaccine trials, so that trials conducted in parts of the world with more COVID-19 activity will still be relevant and acceptable to regulatory agencies and clinicians elsewhere, he said, adding that the FDA has being issuing good guidance on trials during the pandemic.

McClellan also discussed the hurdles faced by manufacturers planning to scale up vaccine production, and he cited the U.S. government’s commitments to large-scale manufacturing capacity for a number of early potential vaccines as evidence that there is already preparation for the waves of demand that could come with an Emergency Use Authorization (EUA) or approval for a vaccine or treatment.

“This is unprecedented in terms of compressing a vaccine timeline. It means that there may be hundreds of millions of doses of vaccines available at the end of this year or early next, when the clinical trials are completed and have been evaluated, that end up not being used at all,” he said. “But that’s what’s needed at the unprecedented scale that we’re dealing with for vaccine manufacturing and to support distribution and access.”

The most promising therapeutics need a similar approach, he said, pointing to Gilead Sciences’ COVID-19 treatment remdesivir, an antiviral that received an EUA from the FDA for use in hospitalized patients. Under current manufacturing capacity, the drug is only able to reach a small share of hospitalized patients that could be helped, he said.

“We need to plan ahead now for making sure we have sufficient capacity for the generic drug treatments that may work, like dexamethasone, and especially for some of these very promising monoclonal antibodies,” he said. “These are problems that can be addressed, but it takes advanced planning to maximize the available capacity and make sure it’s being directed to the particular treatments that are most promising.”

McClellan expressed confidence that the path COVID-19 vaccine candidates are on now will lead to answers to questions about multiple vaccine platforms “in a matter of months.” If those prove effective, the U.S. and other nations could be ready for large scale use “as soon as late this year or early 2021,” he said. — James Miessler