Real-World Data

overview icon Overview

Real-World Data and Evidence in the Evaluation of Medical Products

Real-world data (RWD) and real-world evidence (RWE), collected through the routine delivery of health care, are potentially powerful tools for enhancing the quality and efficiency of clinical trials.

Based on research and collaboration of experts and key stakeholders across the clinical trials ecosystem, CTTI created recommendations, resources, and case studies for using RWD to evaluate trial eligibility criteria and recruit potential research participants. The work promotes greater awareness and appropriate use of RWD sources in clinical trials planning – an approach that, for many, can be a low-risk, high-reward way to bring increased efficiency, shorter timelines, and better patient access to research efforts.

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Clarifying the best approaches for incorporating RWD into clinical trials has the potential to accelerate the appropriate and effective use of these resources and benefit all stakeholders in the clinical trials enterprise.

Real-World Data and Evidence in the Evaluation of Medical Products (“Real-World Evidence”) (2017–2019)

  • Describe how data from electronic health records (EHRs) and payment claims can be utilized to facilitate the planning and execution of clinical trials
  • Describe practical models and operational guidance for the use of RWD to evaluate potential sets of trial eligibility criteria and to recruit potential trial participants directly or via appropriate site selection, as well as provide practical considerations and example language for informed consent documents in trials using RWD or generating RWE

CTTI’s Real-World Data Project will foster greater awareness and appropriate use of RWD to enhance the quality and efficiency of regulatory submission trials.

  • Qualitative interviews with sponsors, academics, healthcare providers, and payers
  • Expert meeting with diverse stakeholders (industry sponsors, academics, patients, healthcare providers and payers, IRBs, EHR providers, technology firms, and federal agencies)

Project Team Members

Role Namesort descending Affiliation
Recommendations Advisory Committee Andrew Bier Genentech - a member of the Roche Group
Recommendations Advisory Committee Angela Dobes Crohn's & Colitis Foundation
Team Member Barbara Bierer Harvard University
Social Scientist Brian Perry Clinical Trials Transformation Initiative
Team Member Cathy Critchlow Amgen
Team Member Claire Meunier Evidation
Team Member David Kronfeld Medidata
Team Member David Thompson Syneos Health
Team Leader Dianne Paraoan Food and Drug Administration
Team Member Eric Peterson Duke University
Team Member Estevan Santana PhRMA
Team Member Farhan (CJ) Hameed Pfizer Inc.
Team Member Guneet Walia Genentech - a member of the Roche Group
Team Leader Jack Sheehan Janssen
Recommendations Advisory Committee Jan Horsky Northwell Health
Team Leader Jane Perlmutter Individual Patient/Caregiver
Team Member Jerry Heatley Abbott
Team Member Jessie Juusola Evidation Health
EC Champion Joe Selby Patient-Centered Outcomes Research Institute
Team Member John Laschinger* Food and Drug Administration
Team Member Ken Carson Flatiron
Team Member Kristin Dolinski PhRMA
Recommendations Advisory Committee Kristin VanGoor Biogen
Recommendations Advisory Committee Lauren Ariniello Scripps Translational Science Institute
Team Member Lesley Curtis Duke University
Project Manager Lindsay Kehoe Clinical Trials Transformation Initiative
Team Member M. Khair ElZarrad FDA/CDER
Recommendations Advisory Committee Marcia Jones Eli Lilly and Company
Recommendations Advisory Committee Maria Ali The George Institute for Global Health
Team Member Naomi Aronson Blue Cross Blue Shield
EC Champion (emeritus) Rich Platt Harvard University
Recommendations Advisory Committee Robert DiCicco IBM Watson Health
Team Member Ruthie Davi Medidata
Team Member Ryan Ferguson Department of Veterans Affairs
Recommendations Advisory Committee Sarah Beeby Clinithink
Team Member Sarah Leatherman Department of Veterans Affairs
Team Leader Scott Evans Society for Clinical Trials
Recommendations Advisory Committee Steven Draikiwicz Sanofi US
Recommendations Advisory Committee Steven Draikiwicz Sanofi-Aventis
Team Leader Sudha Raman Duke University
Recommendations Advisory Committee Ying Wan Becton, Dickinson and Company
Project Manager Zachary Hallinan Clinical Trials Transformation Initiative