Understanding the Role of Patient-Reported Outcomes for Decision-Making in Early-Phase Dose-Finding Clinical Trials.

Abstract

In early-phase dose-finding clinical trials, integrating patient-reported outcomes (PROs) is essential for enhancing patient-centered decision-making. This short communication advocates for several key practices to achieve such integration. Firstly, foster patient-centered communication that ensures patient understanding of the potential benefits of early-phase trials, thereby mitigating therapeutic misconceptions. Secondly, (a) facilitate partnerships to understand and address the underlying reasons for discrepancies between clinician and patient reports of adverse events and (b) facilitate partnerships among clinical trialists, statisticians, clinicians, patients, and advocates to gain diverse perspectives of adverse events and in so doing ensure that patients comprehend how their data will be used. Thirdly, optimize trial design and data collection by (a) determining optimal and feasible frequencies for PRO collection to minimize patient burden while maintaining data integrity and (b) effectively incorporating concordant PROs to guide dose recommendation decisions and adapt trial designs and statistical methods accordingly. Future research will involve investigating the application of these practices in patients within the Virginia Commonwealth University (VCU) Massey Comprehensive Cancer Center Catchment Area. By integrating these recommendations, early-phase dose-finding clinical trials have the potential to achieve more informed and patient-centered objectives.