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Oncology 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.

Discuss how to ensure your PRO strategy meets the latest regulatory guidance. 

Regulatory agencies are demanding more from your PRO strategy

Both the FDA and EMA have put increased emphasis on collecting patient-reported data in oncology trials:

June 2021 – FDA’s Core PROs in Cancer Clinical Trials Guidance for Industry

  • Here the FDA provides detailed guidance on what to measure with PROs, considerations for PRO selection, and how often to collect them.

June 2022 – FDA COA in Oncology Trials Industry Workshop

  • The 7th annual workshop brought industry leaders together, including regulators, experts and patient advocates, to discuss emerging themes relating to the use of PROs in oncology trials.

Our free guide sets out in more detail how these regulatory developments impact your PRO strategy.

Clario’s oncology experience


Oncology trials






Drug approvals

Clario has a world-class Science team to ensure you have the right PRO strategy

Our Science team proactively engages with regulatory bodies and will advise you on how to ensure you have the right PRO strategy to meet the latest regulatory guidance.

  • We advise in areas such as choice of ePRO assessments which will allow you to capture the patient voice, frequency of PRO administration, choice of electronic devices, regulatory communication support and study design considerations.
  • We ensure you’re collecting sufficient patient symptoms to capture high quality data to differentiate your drug, while also simplifying participation and driving patient engagement and compliance.

Bryan McDowell headshot

Bryan McDowell, MSc, MBA

VP, eCOA Science and Consulting

Lindsay Hughes headshot

Lindsay Hughes, PhD, MS

Director, eCOA Science and Consulting

Laura Khurana headshot

Laura Khurana, MPH

Principal Scientific Advisor

Kelly Dumais, PhD

Principal Scientific Advisor