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Updated: May 20, 2025
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Understanding the Role of Patient-Reported Outcomes for Decision-Making in Early-Phase Dose-Finding Clinical Trials.
Richard Brown1, Nolan A Wages2, Li Liu2
1Department of Social and Behavioral Sciences, School of Public Health, Virginia Commonwealth University, Richmond, VA 23284, USA.
Current Oncology (Toronto, Ont.)
|March 26, 2025
Summary
Integrating patient-reported outcomes (PROs) into early-phase clinical trials enhances patient-centered care. This involves clear communication, addressing adverse event discrepancies, and optimizing data collection for better decision-making.
Area of Science:
- Oncology
- Clinical Trial Design
- Patient-Centered Care
Background:
- Early-phase dose-finding trials require patient input for informed decision-making.
- Integrating patient-reported outcomes (PROs) is crucial but challenging.
Purpose of the Study:
- To advocate for key practices for effective PRO integration in early-phase clinical trials.
- To enhance patient-centered decision-making and trial objectives.
Main Methods:
- Fostering patient-centered communication to mitigate therapeutic misconceptions.
- Facilitating partnerships to address clinician-patient discrepancies in adverse event reporting.
- Optimizing trial design and data collection for feasible PRO assessment.
Main Results:
- Recommendations focus on improving communication, understanding adverse events, and optimizing data collection.
- Proposed methods aim to minimize patient burden while ensuring data integrity.
- Incorporating PROs can guide dose recommendations and adapt trial designs.
Conclusions:
- Implementing these practices can lead to more informed and patient-centered early-phase clinical trials.
- Future research will explore these practices within the VCU Massey Comprehensive Cancer Center catchment area.
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