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Ensure your PRO strategy meets regulatory guidance

Regulators expect sponsors to place a stronger emphasis on understanding a drug’s full impact on patients’ functioning, wellbeing and quality of life.

Regulatory-guidance-for-pro-strategy-in-oncology-trials guide

Regulatory agencies are demanding more from your PRO strategy

Both the FDA and EMA have put increased emphasis on collecting patient-reported outcome (PRO) 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.

Find out how regulatory developments impact your PRO strategy – download the guide