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Therapeutic Innovation & Regulatory Science|May 13, 2025
Considerations and Approaches to Establishing Estimates of Meaningful Change for Digital Endpoints as Drug Development ToolsMarie Mc Carthy, Joseph C Cappelleri, Bill Byrom, et al.Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research|April 30, 2023
Updated Recommendations on Evidence Needed to Support Measurement Comparability Among Modes of Data Collection for Patient-Reported Outcome Measures: A Good Practices Report of an ISPOR Task ForcePaul O'Donohoe, David S Reasner, Sarrit M Kovacs, et al.Contemporary Clinical Trials|December 26, 2021
Considerations to address missing data when deriving clinical trial endpoints from digital health technologiesJunrui Di, Charmaine Demanuele, Anna Kettermann, et al.Expert Review of Pharmacoeconomics & Outcomes Research|June 3, 2024
Leveraging sensor-based functional outcomes to enhance understanding of the patient experience: challenges and opportunitiesKatelyn R Keyloun, Jessica Abel, Julia K Garcia, et al.Clinical and Translational Science|November 4, 2024
Implementing sensor-based digital health technologies in clinical trials: Key considerations from the eCOA ConsortiumElena S Izmailova, Danielle Middleton, Reem Yunis, et al.Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research|May 14, 2018
Measurement Equivalence of Patient-Reported Outcome Measure Response Scale Types Collected Using Bring Your Own Device Compared to Paper and a Provisioned Device: Results of a Randomized Equivalence TrialBill Byrom, Helen Doll, Willie Muehlhausen, et al.Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research|June 19, 2018
Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO ConsortiumBill Byrom, Chris Watson, Helen Doll, et al.Journal of Patient-Reported Outcomes|August 4, 2022
Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: qualitative interview findingsLouise Newton, Oliver Knight-West, Sonya Eremenco, et al.Journal of Patient-Reported Outcomes|November 26, 2022
Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: quantitative study findingsStacie Hudgens, Louise Newton, Sonya Eremenco, et al.Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research|June 29, 2023
Recommendations on the Selection, Development, and Modification of Performance Outcome Assessments: A Good Practices Report of an ISPOR Task ForceChris J Edgar, Elizabeth Nicki Bush, Heather R Adams, et al.Pageof 4