Regulatory Guidance For PRO Strategy In Oncology Trials

The regulatory landscape within oncology trials is undergoing rapid evolution. Approvals for oncology drugs now extend beyond mere survival and tumor response metrics, causing regulators to anticipate Sponsors' integration of the patient perspective, gathering more symptomatic data to comprehend a drug's comprehensive impact on patients' functioning, well-being, and quality of life.

Failing to do so may result in the omission of patient-reported data from drug labels, potentially complicating the differentiation of an oncology drug in a fiercely competitive market. Recent regulatory developments influencing your PRO strategy encompass the following key points:

1. June 2021 – FDA’s Core PROs in Cancer Clinical Trials Guidance for Industry: In this guideline, the FDA furnishes detailed advice on what aspects to measure with PROs, considerations for PRO selection, and the recommended frequency of data collection.

2. June 2022 - FDA COA in Oncology Trials Industry Workshop: The seventh annual workshop convened industry leaders, including regulators, experts, and patient advocates, to deliberate on emerging themes related to the utilization of PROs in oncology trials.

Access the article below where Kelly Dumais, Principal Scientific Advisor, and Jowita Marszewska, Scientific Advisor at Clario eCOA, delve into the specifics of how recent regulatory advancements are influencing PRO Strategy.