The Signal Expert insights and opinions on clinical research and drug development. Expert insights and opinions on clinical research and drug development. Author: Bill Byrom Comparative Effectiveness of eConsent: Systematic Review September 5, 2023 Bill Byrom Posted in eConsent Working with a cross industry team from AstraZeneca, Oxford PharmaGenesis, and Nottingham Trent University, Signant was pleased to provide scientific… Read More A Modular Approach to PROM Implementation – Reflections from ISPOR Europe 2022 December 8, 2022 Alexandra Kalpadakis-Smith, Bill Byrom Posted in eCOA Patient-reported outcome measures (PROMs) that measure health-related quality of life (HRQOL) in clinical trials are often composed of several different… Read More Computerized Adaptive Tests: A Primer December 1, 2022 Bill Byrom, Richard Sutherland Posted in eCOA Most patient-reported outcome measures (PROMs) are composed of a fixed number of items – that is, a question and its… Read More Innovation: Using Smartphone Sensors to Instrument At-Home Stair-Climbing Performance Tests August 3, 2022 Bill Byrom Posted in eCOA The drive to collect richer insights during drug development, and to optimize protocols by enabling more remote assessment with fewer… Read More Patient-Reported Outcomes in Medical Device Trials – What We Can Learn From the FDA Guidance May 10, 2022 Bill Byrom Posted in eCOA Patient-reported outcomes data are increasingly collected in medical device clinical trials. In their strategic priorities document [1], the FDA’s Center… Read More Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies March 21, 2022 Bill Byrom Posted in eCOA Visual analogue scales (VASs) in clinical trials ask patients to mark a position on a horizontal line to reflect how… Read More Dealing with Missing Data from Sensors and Wearables January 31, 2022 Bill Byrom Posted in Sensors & Wearables The potential of using sensors and wearables in developing clinical trial measures to better understand the effects of new treatment… Read More Clinical Data Fraud: Detection & Mitigation Strategies January 5, 2022 Bill Byrom Posted in eCOA One of the most compelling arguments for using electronic data capture methods for patient-reported outcome assessments (ePRO) is the ability to ensure and demonstrate data integrity. Electronic data collection allows study teams to use… Read More The Center for Drug Evaluation’s (CDE) draft PRO guidance December 16, 2021 Bill Byrom Posted in eCOA In the landscape of rapidly growing numbers of pharmaceutical clinical trials in China, the Chinese Center for Drug Evaluation (CDE)… Read More What are the best practices for handling changes to ePRO data? October 12, 2021 Bill Byrom Posted in eCOA The recent draft guidance on “computerised systems and electronic data in clinical trials” published by EMA [1] provides useful perspective… Read More 1 2 Next
Author: Bill Byrom Comparative Effectiveness of eConsent: Systematic Review September 5, 2023 Bill Byrom Posted in eConsent Working with a cross industry team from AstraZeneca, Oxford PharmaGenesis, and Nottingham Trent University, Signant was pleased to provide scientific… Read More A Modular Approach to PROM Implementation – Reflections from ISPOR Europe 2022 December 8, 2022 Alexandra Kalpadakis-Smith, Bill Byrom Posted in eCOA Patient-reported outcome measures (PROMs) that measure health-related quality of life (HRQOL) in clinical trials are often composed of several different… Read More Computerized Adaptive Tests: A Primer December 1, 2022 Bill Byrom, Richard Sutherland Posted in eCOA Most patient-reported outcome measures (PROMs) are composed of a fixed number of items – that is, a question and its… Read More Innovation: Using Smartphone Sensors to Instrument At-Home Stair-Climbing Performance Tests August 3, 2022 Bill Byrom Posted in eCOA The drive to collect richer insights during drug development, and to optimize protocols by enabling more remote assessment with fewer… Read More Patient-Reported Outcomes in Medical Device Trials – What We Can Learn From the FDA Guidance May 10, 2022 Bill Byrom Posted in eCOA Patient-reported outcomes data are increasingly collected in medical device clinical trials. In their strategic priorities document [1], the FDA’s Center… Read More Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies March 21, 2022 Bill Byrom Posted in eCOA Visual analogue scales (VASs) in clinical trials ask patients to mark a position on a horizontal line to reflect how… Read More Dealing with Missing Data from Sensors and Wearables January 31, 2022 Bill Byrom Posted in Sensors & Wearables The potential of using sensors and wearables in developing clinical trial measures to better understand the effects of new treatment… Read More Clinical Data Fraud: Detection & Mitigation Strategies January 5, 2022 Bill Byrom Posted in eCOA One of the most compelling arguments for using electronic data capture methods for patient-reported outcome assessments (ePRO) is the ability to ensure and demonstrate data integrity. Electronic data collection allows study teams to use… Read More The Center for Drug Evaluation’s (CDE) draft PRO guidance December 16, 2021 Bill Byrom Posted in eCOA In the landscape of rapidly growing numbers of pharmaceutical clinical trials in China, the Chinese Center for Drug Evaluation (CDE)… Read More What are the best practices for handling changes to ePRO data? October 12, 2021 Bill Byrom Posted in eCOA The recent draft guidance on “computerised systems and electronic data in clinical trials” published by EMA [1] provides useful perspective… Read More 1 2 Next