Insights Newsletters

PHT's educational Insights newsletter delivers ideas and commentary to keep you informed of exciting ePRO innovations that benefit clinical research. Featured issues include how to choose the right technology for your trial, lessons learned from site and subject feedback, and discussions on the PRO Draft Guidance.
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Current Issue

Collecting Electronic Patient-Reported Outcomes (ePROs):

Comparing the 5 Proven Ways to acquire Attributed Patient-Reported Data

The specialized industry of collecting patient-reported outcomes is increasing linearly, in part because global government regulators want to hear directly from the patient, and because the acceleration and availability of electronic collection (vs. paper collection) improves data quality and efficiencies for data analysis and trial management.

This document will review the ePRO market, and outline the five ePRO methods that successfully support the collection of patient-reported data.

Selected Back Issues

PHT Auditing Quality & Compliance

Objective Evidence that Data Collection Processes Operate Within Established Policies and Procedures

Learn how PHT's vigilance and continuous, rigorous testing within Quality Management & Compliance ensure that every trial's final archive has all the necessary evidence to allow evaluation of the conduct and data of the trial.

Improving Trial Efficiencies: Making the Business Case for ePRO *

This issue focuses on quantifying the Return on Investment of ePRO and examines in detail the cost of paper vs. ePRO as well as FDA and EMEA recommendations about PRO collection. Two case studies features demonstrate that ePRO is essential for cost-savings when running clinical trials that demand the highest data quality.

eClinical Data Integration: Cases and Best Practices *

This educational case study details best practices and recommendations for numerous types of eClinical data integration, including sending ePRO data to an EDC system, merging multiple streams of data to determine eligibility, incorporating data from measurement devices such as PEF meters and glucometers, using clinical data management systems, and more.

ePRO: the Site Perspective *

Dr. Raymond discusses how sites feel about ePRO - both the good and the bad - based on interviews conducted with experienced principal investigators and study coordinators around the world.

ePRO: the Subject Experience *

Dr. Valdo Arnera examines how clinical trial subjects feel about, and react to, electronic patient diaries, based on interviews with patients and study coordinators throughout the United States and Europe.

PHT eSense Sensors *

Dr. Raymond discusses how wirelessly integrating medical devices (such as the PHT eSense PiKo) with eDiaries prevents false self-reported data and helps sponsors achieve new heights in clinical research.

eDiary Design Best Practices *

Dr. Marino describes the five experience-based best practices to optimize eDiary design and to maximize site and subject acceptance.

Choosing Between ePRO, IVRS and Paper *

Phil Lee compares the three most prominent PRO data collection methodologies in the context of study-specific selection criteria.

Welcome to Insights *

In the premier issue of Insights, Phil Lee and Dr. Raymond review ePRO market trends and discuss wireless LogPad security.