Inclusion Of Health-Related Quality Of Life (HRQoL) And Other Patient-Reported Outcomes (PROs) In FDA Labels

A conversation with Sarah Cadarette

For years, the biopharmaceutical industry has been discussing the importance of patient-reported outcomes. But how often does this crucial data make it onto the official U.S. Food and Drug Administration (FDA) label where it can inform prescribing decisions? A recent investigation confirms that PROs are significantly underrepresented. By analyzing the labels for drugs in therapeutic areas where quality of life is a major concern, researchers found a surprising variety in the measurement tools used but a consistent lack of inclusion in the final labeling. This raises important questions about how the industry and regulators value the patient perspective in assessing a treatment’s overall benefit.

Discover the key takeaways from this important research and what they signal for the future of clinical trial design by reading the full interview.