RTI-HS’s expertise in research that measures how patients feel or function has been tapped for the November Special Section on Clinical Outcome Assessments in Therapeutic Innovation & Regulatory Science, the official journal of DIA. Five staffers from our Patient-Reported Outcomes practice area, Ari Gnanasakthy, MSc, MBA, Valerie Williams, PhD, Lori McLeod PhD, Lauren Nelson, PhD, and Carla DeMuro, MS, co-authored 3 articles examining research measures that help drug manufacturers understand what really matters to patients so that they can identify key factors that lead to adherence and, ultimately, successful therapeutics.
O'Donohoe P, Lundy JJ, Gnanasakthy A, Greene A. Considerations for requiring subjects to provide a response to electronic patient-reported outcome instruments. The advent of electronic data capture has introduced the capability to require patient-reported outcomes (PRO) study subjects to provide a response to an item before proceeding to the next item. In this article, the authors provide guidance on the appropriate circumstances which allow a subject to opt out of responding to ePRO items.
Williams V, McLeod L, Nelson L. Advances in the evaluation of longitudinal construct validity of clinical outcome assessments. This article focuses on methods to evaluate longitudinal construct validity. The authors describe a sample of these methods and provide considerations and recommendations for designing longitudinal construct validity evaluations of clinical outcome assessments.
Gnanasakthy A, DeMuro C. Overcoming organizational challenges of integrating patient-reported outcomes in oncology clinical trials. The authors cite increasing calls for demonstration of value of new cancer drugs from payers, patients, and their caregivers as a signal that study teams should consider the utility of PROs beyond regulatory needs. This article provides recommendations for advancing patient-centric drug development.