RPI Blog New FDA Draft Guidance Provides Insights on Use of PROs in Oncology Trials

Incorporating patient-reported outcomes (PROs) into clinical trials can help sponsors better understand patients' symptoms and how a therapy will affect their quality of life, and these insights can be particularly valuable in oncology research. However, there has been a lack of guidance to help sponsors ensure consistency and quality when incorporating PROs into cancer drug applications. That's changed with the recent publication of a new draft guidance from the U.S Food and Drug Administration's (FDA) Oncology Center of Excellence (OCE),Read moreThe post New FDA Draft Guidance Provides Insights on Use of PROs in Oncology Trials appeared first on Regulatory Professionals.