ERT eCOA POSTERS AT ISPOR 2017

Preview the latest research from our Clinical Science team and be sure to stop by booth 210 if you’re at the show.


GET A JUMP-START ON YOUR ISPOR EXPERIENCE

ERT’s expert team of PRO/eCOA clinical scientists will present four posters at the 2017 ISPOR annual meeting. Their research focuses on PRO/eCOA, subject training and patient engagement for compliance. Preview their posters below, and be sure to join them onsite to get an in-depth review, ask questions, and more!

PATIENTS CONSIDER TRAINING A NECESSARY PART OF CLINICAL TRIALS, PREFERRING READILY-ACCESSIBLE INTERACTIVE ELECTRONIC TRAINING

As patient-reported outcomes (PROs) are often primary or secondary endpoints in clinical trials, regulatory PRO guidance recommends patient training to improve data quality and reduce variability. This study explored patients’ views on the importance of training and their preferred mode for training.

Sponsors rely on training for standardized endpoints
When patients’ understanding differs, their data are inconsistent

ERRORS IN PATIENT REPORTED OUTCOMES (PROs): PATIENTS’ UNDERSTANDING OF HOW TO RECORD A HEADACHE DAY

PROs collected as endpoints in clinical trials often require patients to report symptom severity, frequency, or the impact of symptoms on quality of life. It is generally accepted that variability in PROs should be reduced to ensure data quality, however, assessment variability due to the patient’s interpretation of measurement parameters may be overlooked. This study reveals the discrepancies in how patients report a headache.

PATIENT REPORTED OUTCOMES (PROs) ARE SUBJECT TO INTERPRETATION ERRORS: PATIENTS’ UNDERSTANDING OF HOW TO REPORT PAIN SEVERITY
OVER A PERIOD OF TIME

PROs are often primary endpoints in clinical trials, serving to determine treatment safety and/or efficacy. In clinical trials for pain treatments, it is important to accurately determine pain severity to assess treatment efficacy. Varying patient interpretations will render inconsistent and low-quality data. This study demonstrates data variability of untrained patients.

Variable patient interpretations generate discordant data
Patients’ Understanding of Stool Count Reporting

PATIENTS’ UNDERSTANDING OF REPORTING STOOL FREQUENCY IN CLINICAL TRIALS

Clinical trials for gastrointestinal (GI) tract diseases often involve a patient reported outcome (PRO) item, specifically stool frequency, as a primary outcome measure. The aim of this study was to examine patients’ understanding of how to accurately report stool count.