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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

The drive to collect richer insights during drug development, and to optimize protocols by enabling more remote assessment with fewer…

With Sensors and Wearables, It’s Not All About the Hardware

The rapid adoption and incorporation of technology into many aspects of clinical research enables new opportunities to improve drug development….

Patient-Reported Outcomes in Medical Device Trials – What We Can Learn From the FDA Guidance

Patient-reported outcomes data are increasingly collected in medical device clinical trials. In their strategic priorities document [1], the FDA’s Center…

Measurement Comparability of Electronic and Paper Administration of Visual Analogue Scales: A Review of Published Studies

Visual analogue scales (VASs) in clinical trials ask patients to mark a position on a horizontal line to reflect how…

Clinical Data Fraud: Detection & Mitigation Strategies

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…

The Center for Drug Evaluation’s (CDE) draft PRO guidance

In the landscape of rapidly growing numbers of pharmaceutical clinical trials in China, the Chinese Center for Drug Evaluation (CDE)…

What are the best practices for handling changes to ePRO data?

The recent draft guidance on “computerised systems and electronic data in clinical trials” published by EMA [1] provides useful perspective…

eCOA Best Practices: Ensuring Timely Delivery of Translations

With more than half of all registered studies occurring in locations outside of the U.S. and the continued upward trajectory…

Selecting a Fit-For-Purpose Device

In today’s protocols, we continue to see an increased appetite to study clinical endpoints derived from wearables and sensors (i.e.,…

3 Reasons Oncology Studies Should Consider a Pre-Configured eCOA Solution

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…