The Signal Expert insights and opinions on clinical research and drug development. Expert insights and opinions on clinical research and drug development. Category: eCOA 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 With Sensors and Wearables, It’s Not All About the Hardware July 13, 2022 Cristina Rhoads Posted in eCOA The rapid adoption and incorporation of technology into many aspects of clinical research enables new opportunities to improve drug development…. 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 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 October 12, 2021 Bill Byrom Posted in eCOA The recent draft guidance on “computerised systems and electronic data in clinical trials” published by EMA [1] provides useful perspective… Read More eCOA Best Practices: Ensuring Timely Delivery of Translations October 4, 2021 Signant Health Posted in eCOA With more than half of all registered studies occurring in locations outside of the U.S. and the continued upward trajectory… Read More Selecting a Fit-For-Purpose Device September 28, 2021 Bill Byrom Posted in eCOA In today’s protocols, we continue to see an increased appetite to study clinical endpoints derived from wearables and sensors (i.e.,… Read More 3 Reasons Oncology Studies Should Consider a Pre-Configured eCOA Solution September 2, 2021 Signant Health Posted in eCOA The FDA’s recent guidance placed an increased emphasis on patient-reported outcome measures (PROMs) for oncology trials. This data provides better insight into the patients’ disease-related symptoms, side effects of treatment, and effect… Read More 1 2 Next
Category: eCOA 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 With Sensors and Wearables, It’s Not All About the Hardware July 13, 2022 Cristina Rhoads Posted in eCOA The rapid adoption and incorporation of technology into many aspects of clinical research enables new opportunities to improve drug development…. 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 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 eCOA Best Practices: Ensuring Timely Delivery of Translations October 4, 2021 Signant Health Posted in eCOA With more than half of all registered studies occurring in locations outside of the U.S. and the continued upward trajectory… Read More Selecting a Fit-For-Purpose Device September 28, 2021 Bill Byrom Posted in eCOA In today’s protocols, we continue to see an increased appetite to study clinical endpoints derived from wearables and sensors (i.e.,… Read More 3 Reasons Oncology Studies Should Consider a Pre-Configured eCOA Solution September 2, 2021 Signant Health Posted in eCOA The FDA’s recent guidance placed an increased emphasis on patient-reported outcome measures (PROMs) for oncology trials. This data provides better insight into the patients’ disease-related symptoms, side effects of treatment, and effect… Read More 1 2 Next