The FDA formally launched the Oncology Center of Excellence and named Dr. Richard Pazdur its director effective Jan. 19, advancing the Obama administration's Cancer Moonshot Initiative.
The OCE is supposed to leverage the FDA across its centers for devices, drugs and biologics to accelerate the development of oncology-related medical products and promote a coordinated approach to clinical evaluation, according to the FDA website. FDA Commissioner Dr. Robert Califf said in a Jan. 19 statement that the agency is taking steps to formalize its structure through a reorganization within the FDA’s Office of Medical Products and Tobacco.
"The OCE emulates both academia and cancer care centers, which are increasingly organized in multidisciplinary models to enhance collaboration, which is so essential when confronting a complex disease like cancer," Pazdur wrote in a post on the FDA blog following his appointment. "This new center will also continue to facilitate the incorporation of the patient view in our regulatory decision-making, which has become a personal mission for me since my wife Mary, an oncology nurse, died of ovarian cancer last November."
Pazdur also has an interest in reforming the agency's cancer clinical trial paradigm.
In a September blog post on the FDA website, he discussed possible new approaches, including broader eligibility criteria and the use of common control trials. Such trials would involve multiple different drugs for the same indication, including those from multiple manufacturers. Use of a common control or placebo arm would decrease the number of patients that need to be recruited and enrolled, he wrote.
And in a May 26 article in the New England Journal of Medicine, Pazdur discussed the regulatory challenges posed by the new "seamless" trial designs, which dispense with the three traditional phases. He suggested their use should be limited to potential treatments that earn the FDA's breakthrough therapy designation.