Cancer drug developers will learn from speed of Covid vaccine race: FDA leaders

 The whole world watched in awe as the first two Covid-19 vaccines quickly made their way through clinical trials, offered stellar efficacy results and were quickly ushered across the FDA finish line in record time.

As a result, leaders of the FDA’s Oncology Center of Excellence wrote recently in the Cancer Journal that now is the time to leverage the lessons learned from that high-speed race and translate them into new opportunities for future oncology drug development.

Among the highlights worth repeating in cancer trials: frequent, open, clear communication and information sharing across FDA, academia, and community/industry partners, as well as the speed and agility of trial initiation, and the “collective sense of necessity,” all of which may benefit the development of new cancer therapies, Donna Rivera, associate director of pharmacoepidemiology in the FDA’s OCE, and colleagues wrote.

Offering the example of the UK’s RECOVERY trial, which swiftly brought conclusions on the merits of several Covid-19 treatments, the OCE authors called for more adaptive trial methods, common protocols and common control arms in oncology, as well as more on platform and basket trial designs, on which the agency recently offered guidance.

The FDA also explained how there’s now “ample evidence that protocols have become more complex over time and that a conscious effort to simplify will make participation more feasible for investigators, particularly when trials are conducted in the context of clinical care.”

And while cancer drug development has been slow to adopt decentralized trial methods and telehealth, due to concerns about data variability, OCE authors called to increase the flagging of remote assessments at the case-report form level to allow analyses to unlock further information on the potential effects of decentralized modifications on data variability.

The second iteration of the 21st Century Cures Act is also making its way through Congress and seeks to expand the use of real-world evidence in confirmatory trials for certain accelerated approvals.

Cures 2.0: Bipartisan House bill would allow RWE to satisfy confirmatory trial requirements for accelerated approvals

Rick Pazdur, head of the FDA’s OCE, told Endpoints News in a statement, “Use of RWE for aid in regulatory decision-making would depend on the strength of the available evidence and its applicability to the patient population.”

The OCE authors also noted that while the use of real-world data informed and guided the pandemic response, “there is a significant distinction” between the use of RWD for descriptive purposes and using RWD to generate evidence that determines whether a drug works.

“The pandemic provides the field with a clear lesson that the benefit of RWD availability and faster analytics must be balanced with the importance of careful design and methods to create the high-quality RWE necessary to support evidence-based intervention strategies,” they wrote. “The pandemic can become a watershed moment to forge unprecedented change in health care delivery and clinical trials through a dynamic modernization effort supported by adequate infrastructure funding and carefully coordinated global stakeholder collaboration.”

https://endpts.com/cancer-drug-developers-will-learn-from-the-blazing-speed-of-the-covid-19-vaccine-race-fda-leaders-say/