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Overcoming Organizational Challenges of Integrating Patient-Reported Outcomes in Oncology Clinical Trials

Ari Gnanasakthy1, Carla DeMuro1

  • 11 RTI Health Solutions, Research Triangle Park, NC, USA.

Therapeutic Innovation & Regulatory Science
|September 18, 2018
PubMed

Insights

Patient-reported outcomes (PROs) are crucial for cancer drug development but face implementation challenges. Optimizing PROs requires rigorous application of guidance and strategic planning beyond regulatory requirements.

Area of Science:

  • Oncology
  • Clinical Trial Design
  • Patient-Reported Outcomes

Background:

  • Cancer patients often experience multiple distressing symptoms impacting quality of life.
  • Oncology drug development faces unique challenges for incorporating patient-reported outcomes (PROs) due to high attrition rates, rapid development, and survival-focused endpoints.

Purpose of the Study:

  • To address the challenges in implementing patient-reported outcomes (PROs) in oncology clinical trials.
  • To provide recommendations for optimizing the inclusion and utilization of PROs in cancer drug development.

Main Methods:

  • Review of challenges in PRO integration within oncology research.
  • Analysis of regulatory guidance and resource pressures affecting PRO implementation.
  • Discussion of strategies for optimal PRO strategy development.

Main Results:

  • Rigorous application of US Food and Drug Administration's PRO guidance can be challenging.
  • Budgetary constraints and regulatory interpretations can hinder optimal PRO inclusion.
  • PROs offer value beyond regulatory needs, essential for demonstrating drug value.

Conclusions:

  • Optimal PRO implementation in oncology requires strategic planning and adherence to guidance.
  • Utilizing off-the-shelf PRO measures and early regulatory discussions are key.
  • Treating PRO endpoints with the same rigor as other trial endpoints is essential for robust oncology research.
Keywords:
PRO guidancechallengesclinical trialsoncologypatient-reported outcome

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