Posted by Michael Wonder on 30 Mar 2018
Statement from FDA Commissioner on FDA’s efforts to enhance the patient perspective and experience in drug development and review
30 March 2018 - Benefit-risk assessment is at the heart of what we do to ensure that Americans have access to medical products that are safe, effective and meet their needs.
But we’re also deeply aware that serious chronic illnesses aren’t monolithic. Patient perception of the benefits and risks of different treatment options can vary based on the stage of the disease, the age of onset, alternative therapies available to treat the disease (if any) and whether a novel therapy improves a patient’s ability to function normally, slows the rate of disease progression or impacts other aspects of a patient’s quality of life.
A 45-year-old father of two who is diagnosed with aggressive prostate cancer may have very different goals than an 80-year-old man diagnosed with the same disease.
