Regulatory guidance for PRO strategy in oncology trials
August 12, 2022Oncology drug approvals are now based on more than just survival and tumor response. Regulators expect Sponsors to incorporate the patient voice and collect more symptomatic data to understand a drug’s full impact on patients’ functioning, wellbeing and quality of life. Failure to do so may lead to:
- Missing important patient symptoms and experiences
- Denial of getting patient-reported data on your drug label
Ultimately it may make it harder to differentiate your drug in a highly competitive market.
In our new guide, Kelly Dumais, Principal Scientific Advisor and Jowita Marszewska, Scientific Advisor at Clario eCOA, set out in more detail how these regulatory developments impact PRO Strategy.
