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Area of Science:

  • Clinical trial methodology
  • Regulatory science
  • Patient-reported outcomes

Background:

  • Performance outcome (PerfO) assessments are crucial for measuring cognitive and physical function in drug development.
  • Current scientific guidance for PerfO measure development, implementation, and interpretation is limited, posing challenges for sponsors and regulators.
  • Lack of standardized approaches hinders the reliable assessment of patient functioning in clinical trials.

Purpose of the Study:

  • To explore the evidentiary, methodologic, and operational challenges associated with PerfO measures in clinical trials.
  • To identify potential solutions and best practices for the development, implementation, and interpretation of PerfO assessments.
  • To advance the discussion on using PerfO measures to support the registration of new treatments by assessing patient functioning.

Main Methods:

  • Convened a 2-day workshop in December 2016 involving experts from regulatory bodies, industry, academia, and public-private consortia.
  • Synthesized workshop discussions and expert input to summarize challenges and propose solutions.
  • Focused on evidentiary, methodologic, and operational aspects of PerfO measure utilization.

Main Results:

  • Identified key challenges in the scientific guidance for PerfO assessments.
  • Highlighted gaps in knowledge requiring further research and collaboration.
  • Provided a framework for addressing PerfO measure complexities in drug trials.

Conclusions:

  • There is a critical need for enhanced scientific guidance and standardized approaches for PerfO measures in drug development.
  • Collaborative efforts among stakeholders are essential to overcome current challenges.
  • Further research is necessary to refine PerfO measure development and interpretation for robust patient functioning assessment.