ePRO: Going from Good to Great

Patient-reported outcomes are playing a more prominent role in the clinical research than ever before, thanks to a focus on real-world evidence and the potential of personalized medicine. But have the methods of capturing PRO kept pace with our ambitions for better data? Will paper forms suffice amidst growing concern over data quality? And how can we meet participants’ justified demand for convenience? 

Join us as we explore these and related questions at our SCDM 2017 panel session, taking place at 1:30pm on Monday, September 25th in the Ritz Carlton Ballroom V & VI.

 

Panel

Ben Baumann, BS
Chief Operating Officer
OpenClinica

Sesson chair

Aline Cornelissen, BS, MS
Manager, Data Technologies and Programming
Chiltern

Panelist

Catherine Miller, BS, CCDM
Manager, Clinical Data Management
Sera Prognostics

Panelist

Monika Vance, BS, MBA
Founder and Managing Director
Santium

Panelist

Session Overview

As patient-centric medicine and a focus on effectiveness continue to dominate the healthcare and research landscapes, patient reported outcomes are becoming more essential to the design and conduct of clinical trials. However, traditional methods of ePRO data collection (provisioned devices, existing instruments) are often costly and cumbersome, and fail to deliver the highest possible quality of outcomes data. We must engage patients on their time, through their channels, to maximize the completeness, timeliness, and accuracy of reporting. Join this panel to hear from a representative cross section of seasoned trial leaders on how they pushed their ePRO initiatives from good to great, by implementing “bring your own device” (BYOD) whenever possible, offering better training and support to study subjects when provisioned devices were necessary, and conforming to all regulations in the still new BYOD modality. This session is applicable for all conference attendees, but ideal for data managers, COA leads and regulatory professionals with limited experience in trials incorporating these strategies.

Learning objectives

  1.     Understand the virtues and drawbacks of three modalities in collecting patient-reported outcomes: paper, provisioned device, and BYOD (“bring your own device”)
  2.     Gain knowledge on both long-standing and new regulatory considerations pertaining to electronic clinical outcome assessment (including ePRO)
  3.     Based on study processes and participant profile, evaluate the fitness of a BYOD approach to ePRO for any study incorporating patient-reported outcomes

    CDM Certification Competencies

    1. Electronic Data Collection   
    2. Clinical Trials Processes, Roles, and Responsibilities
    3. Processing External Data

    Let’s keep the conversation going!

    Did you attend the session? Missed it but would like a summary? Send word to our panel with the form below. Together, we can move ePRO from good to great!