Insights Newsletter

Training technologies impact recruitment, compliance and site satisfaction. Learn how the Internet has modernized clinical trial training, and how Sponsors can use a blend of technologies to ensure consistent, convenient and thorough training of Study Monitors, Clinical Investigators and Study Coordinators.

PRO and ePRO systems provide significant insight into what happens to patients with cancer as they experience the disease and undergo treatment, while also enabling real time monitoring of adverse effects. The data they collect can measure treatment side effects, drug effects, patients’ symptoms and functioning, quality of life, compliance with regimens and toxicity endurance.

Diabetes clinical research often includes PROs to measure symptoms and safety, evaluate quality of life, and record the economic burden. This edition of Insights highlights the conversion from paper to PRO for a PRO instrument designed to assess the impact of diabetes on the quality of life of patients with diabetes.

Two recent regulatory publications from FDA and EMA address the topic of electronic source data in clinical investigations. While the views are slightly different, these documents provide clarity concerning the expectations of regulatory authorities regarding electronic source data. This Issue explores the topic of electronic source data and identifies some key concepts that are common (and seemingly agreed upon) within these publications.

Collecting PROs via the Web: Are Data Suitable for Regulatory Submissions?
This Insights issue describes the browser-based electronic patient reported outcome (ePRO) collection method and explains: which types of trials are best suited for this type of data collection; psychometric validations required with this collection modality; and how and when ePRO data collected via the web can support a claim.

When and How to Justify Electronic Patient-Reported Outcomes (PROs)
The importance of learning how patients feel and function when taking a new clinical therapy has been acknowledged by the FDA, EMA and other global regulatory authorities. This issue of Insights is intended to identify the costs (delays and expenses) of collecting patient-reported outcomes on paper; and compare these against electronic PRO capture.

The specialized industry of collecting electronic patient-reported outcomes is increasing - in part because global government regulators want to hear directly from the patient, and also 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.

Final FDA Guidance Brings PRO and ePRO Mainstream
FDA’s PRO Final Guidance helps Sponsors and CROs understand how to include the patient viewpoint in the clinical trials that support market authorization for their medical products. The Guidance shows that FDA understands the pivotal role of PRO measures in establishing clinical benefit. This Insights edition provides readers with an executive summary of the document as it relates to ePRO.

Inspectors and Auditors Require Comprehensive ePRO Archives
Sponsors and regulators rely on the ePRO archive to prove that trial data are attributable and accurate; and that the trial can be reconstructed at any time. Any omissions can risk regulatory warnings, findings and possible data rejection. This issue describes the PTH ePRO Archive, and explains how and why it exceeds regulatory requirements and industry guidelines.

PHT Auditing Quality & Compliance
This issue includes an article entitled PHT Auditing, written by Rod Thorell, Director of Quality Management & Compliance at PHT Corporation; an interview entitled Why Auditing is Critical to Sponsors with Laura Araujo, a Senior Consultant of Quality Management at Halloran Consulting Group; and a brief Question/Answer segment with Rod that reviews the contemporary issues of auditing, and explains what sponsors commonly ask of PHT’s auditing processes and procedures.

Sponsors Require Trustworthy Patient Reported Outcomes
Sponsors and CROs must be assured that clinical data collected for regulatory submissions comply with the regulations and guidance around the world for data quality and integrity. Regulatory agencies are placing more emphasis on the voice of the patient, and they are auditing patient reported data for validity and trustworthiness. This issue examines how PHT has demonstrated that capturing patient data electronically instead of on paper provides valid data more reliably and efficiently.

Improving Trial Efficiencies: Making the Business Case for ePRO
To date, approximately 20% of all trials with patient reported endpoints are using ePRO solutions to collect efficacy data. As adoption of ePRO technology continues to increase, sponsors are finding new ways to justify its ROI and to identify trials that are best suited to ePRO (versus paper). This issue describes how several market-leading sponsors have quantified the benefits of better data quality, including case examples.