COA in PROgress

John Fox, a digital and tech landscape analyst, and Olivier Wong, an expert in evidence quality and patient-centric processes, explore the future of Clinical Outcome Assessments. They discuss the challenges of patient engagement with digital tools and the importance of aligning technology with real-world usability. The duo emphasizes patient satisfaction's role in improving outcomes and shares insights on integrating digital health for better assessment of mobility changes, particularly in motor impairments like Parkinson's disease.

Ethan Basch, an expert in patient-reported outcome measures, and Norah Crossnohere, who specializes in their impact on healthcare stakeholders, dive into the integration of these measures in clinical practice. They reveal how PROs enhance real-time patient care while navigating challenges in post-pandemic settings. The duo emphasizes training for healthcare providers and effective communication with patients to boost engagement. Their insights shed light on the future adjustments needed to optimize healthcare quality for both patients and providers.

Experts Mel Calvert and Hilary Jones discuss choosing the right digital COA measures for clinical trials, exploring the shift to electronic data collection, benefits of outsourcing questionnaire delivery, challenges of incorporating wearables, and obstacles in implementing electronic outcome assessments.

John Powers and Cheryl Coon discuss framing COA endpoints, emphasizing the importance of protocol clarity, treatment benefits, evidence, and patient-centric analysis. They also explore the complexities of specifying endpoints, the balance between specificity and broadness, and the innovative approach to developing outcome measures in clinical trials.

Professors Michael Brundage and David Cella discuss patient-reported outcome measures and prioritization measures. Topics include validity, reliability, scoring interpretability, creating tailored measures in clinical trials, developing questions for item banks, challenges in measurement across diverse populations, and strategies to ensure clarity and validity in healthcare measurements.

Patient-centered drug development expert Sonya Eremenco and clinical research specialist John Powers discuss the importance of putting patients at the heart of COA approaches in clinical research, from concept to endpoint positioning. They explore the significance of aligning COA strategy with patient priorities, measuring disease attributes, and consulting patients early to determine key measures for improved participation and relevant metrics.

Health technology assessment expert Paul Miller and patient-reported outcomes specialist Olivier Wong delve into the integration of patient perspectives in decision-making processes, the significance of high-quality patient experience data, the challenges of aligning methodologies for joint clinical assessments, and the evolution of patient-reported outcomes in health technology assessment.

Chad Gwaltney discusses the evolving importance of COAs in drug development, emphasizing a patient-centered approach. They explore the evolution of COA guidance documents, the importance of fit for purpose PRO instruments, and the evolving acceptance of quality of life measures in drug development. The conversation highlights the shift towards patient-centric evolution in drug development and the significance of incorporating patient perspectives in regulatory decisions.