Alec Stone
Alec Stone MA, MPA, ONS Public Affairs Director

The U.S. Food and Drug Administration’s (FDA’s) mission is primarily to protect the American public by regulating the sale and development of consumer items like cosmetics, food, tobacco products, medication, and much more. However, a lesser known arm is FDA’s Oncology Center of Excellence (OCE), established to further prevention, detection, patient-centered research, and cancer-specific education.

The OCE has developed the new Patient-Focused Drug Development program to engender FDA’s partnerships with external shareholders involved in patient-centered outcomes research in an effort to better treat patients—not just their diseases. Paul Kluetz, MD, associate director of patient outcomes at OCE, offered insight into the program’s priorities, including:

  • Actively engaging with patients and advocacy groups
  • Fostering research into measurement of the patient experience
  • Generating science-based recommendations for regulatory policy

Elaborating on the initiative’s goals, Kluetz wrote, “The overarching goal of the program is to identify rigorous methods to assess the patient experience that will complement existing survival and tumor information to better inform a cancer therapy’s effect on the patient.”

FDA is highly engaged with patients and providers alike. ONS has held multiple meetings with the agency to offer nurse-oriented information on issues related to oncology. Partnerships are being formed for further discussions about education and awareness. Most importantly, FDA understands that the important aspects of oncology care revolve around a patient-centered model.

In his article, Kluetz emphasized the importance of a patient-focused program: “Patients treated for cancer have other meaningful concerns as well, such as coping with treatment-related side effects that can impact their ability to function, as well as other aspects of their quality of life. In short, cancer therapies treat patients—not just their disease.”