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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.

Author: Bill Byrom

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…

Dealing with Missing Data from Sensors and Wearables

The potential of using sensors and wearables in developing clinical trial measures to better understand the effects of new treatment…

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The recent draft guidance on “computerised systems and electronic data in clinical trials” published by EMA [1] provides useful perspective…

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.,…

EMA Draft Guidance: Here’s What It Tells Us About BYOD

The European Medicines Agency (EMA) draft guidance released this past June on “computerized systems and electronic data in clinical trials” to replace their 2010 reflection paper on…

Key Technology Elements for Successful Hybrid Trials

As the industry continues to predict and debate what the “new normal” in clinical development will look like in an…

Mixing eCOA Modes: How to Respond Post-COVID Mitigation

Over the early months of the pandemic, we worked with clients to implement mitigations for studies that continued but were…