Posted tagged ‘U.S. Food and Drug Administration’

FDA Recognizes Need for Patient-Centric Drug Development

September 20, 2013

Over the last two decades, Dr. Lindsay Rosenwald has founded and invested in an array of biotechnology start-ups, funding research and development for drugs to treat leukemia and prostate cancer. Today, Dr. Lindsay Rosenwald serves as a founding partner at an investment partnership in New York City.

Recently, the New England Journal of Medicine published an article discussing the need for more patient-centered drug development, specifically surrounding cancer treatment therapies. Physicians report that patients often ask how medications will make them feel, yet clinical trial data rarely includes patient accounts of how the drug affected their everyday lives. Thanks to advanced drugs and therapies, patients are often able to live longer with a disease; these advances only increase the importance of reporting on how a certain drug affects the patient’s quality of life.

Additionally, the U.S. Food and Drug Administration has recognized that drug developers often focus on a drug’s end result without taking the patient’s perspective into consideration. The agency has started taking steps to alleviate this challenge, but the aforementioned article recommends that the FDA raise its standards even higher. The New England Journal of Medicine’s commentator suggests identifying patient-centered outcomes and metrics during the earliest stages of drug development and using them to analyze patient feedback throughout pivotal trials. He believes that adopting this process could help improve quality of life for thousands of cancer patients.