Shelley Fuld Nasso, NCCS Senior Director of Policy, was a panelist at the June 28, 2013, Food and Drug Administration (FDA) meeting on patient-focused lung cancer drug development. Ms. Fuld Nasso offered advice to FDA about strategies for incorporating patient needs and preferences in lung cancer drug development. She concentrated her remarks on the need for lung cancer patients to better understand the short- and long-term goals of treatment and whether treatment will be curative or palliative and identified three key questions that lung cancer patients should discuss with their care team: 1) if cure is not likely, is there a clinical trial that might offer an increased benefit over currently available treatment?; 2) if cure is not likely, will chemotherapy and/or other modalities delay tumor progression and relieve my symptoms? and 3) does my physician understand what factors would contribute to the values that comprise my quality of life? Which of the possible treatment options would best preserve those qualities?
The patient-focused drug development program is an initiative mandated by the Food and Drug Administration Safety and Innovation Act (FDASIA) and is intended to provide the agency the advice of patients regarding the risks and benefits of new cancer drugs as well as the perspective of patients regarding unmet medical need.