How your PRO strategy can differentiate your drug
Sponsors can help differentiate their drugs by using:
- A range of PRO assessments: Understand the full scale of patient symptoms by using PROs that measure areas like physical and role function, symptomatic adverse events, and tumor-related symptoms.
- Early-stage PROs (in phases I & II): Understand the full range of potential symptoms early so you can use the data to optimize your Phase III PRO strategy—ensuring that the most suitable symptomatic information is collected.
- Technologies which collect objective data: Incorporate wearable and precision motion technologies that provide even richer information on how patients feel and function. Techniques may include continuous data actigraphy to measure fatigue or in-clinic postural sway measurements.
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.
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