The FDA encourages collection and reporting of patient-reported outcomes (PROs) in clinical trials, but a substantial proportion of applications seeking product approval lack these data. Assessment of patient-reported outcomes in clinical trials is on the rise, but they frequently are absent from requests for FDA drug approvals.
While there is, rightfully, a lot of optimism around the latest treatments for newly diagnosed multiple myeloma, not everyone is gaining the same benefit, said Kenneth Shain, MD, PhD, of H. Lee Moffitt Cancer Center.