FDA to Promote Seamless Designs for Cancer Clinical Trials
To achieve the national cancer moonshot’s goal of accelerating cancer research, the FDA is planning to encourage more seamless, adaptive clinical trial designs for oncologic drugs.
The agency is looking to speed up the regulatory pathway, possibly shifting away from traditional Phase I, II, and III development, wrote Richard Pazdur, acting director of the FDA’s Oncology Center of Excellence, in a blog post on the agency’s website.
“Adopting this approach could complement FDA’s expedited regulatory programs such as breakthrough designation and accelerated approval to get products to patients in the most efficient manner possible,” Pazdur wrote. He said the new emphasis on clinical trial design stems from recent advances in the scientific understanding of cancer.