Project:

Real World Evidence

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.

CTTI is creating recommendations and supporting tools for using RWD to evaluate trial eligibility criteria and recruit potential research participants, as well as example language for informed consent documents in trials using RWD. The work, based on research and collaboration of experts and leaders across the clinical trials enterprise, aims to promote greater awareness and appropriate use of RWD sources in clinical trials planning.

in detail icon In Detail

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–ongoing)

  • 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 Evidence 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

Rolesort descending Name Affiliation
EC Champion Joe Selby Patient-Centered Outcomes Research Institute
EC Champion (emeritus) Rich Platt Harvard University
Project Manager Zachary Hallinan Clinical Trials Transformation Initiative
Project Manager Lindsay Kehoe Clinical Trials Transformation Initiative
Social Scientist Brian Perry Clinical Trials Transformation Initiative
Team Leader Scott Evans Society for Clinical Trials
Team Leader Jane Perlmutter Individual Patient/Caregiver
Team Leader Jack Sheehan Janssen
Team Leader Dianne Paraoan Food and Drug Administration
Team Leader Sudha Raman Duke University
Team Member Ryan Ferguson Department of Veterans Affairs
Team Member Barbara Bierer Harvard University
Team Member Farhan (CJ) Hameed Pfizer Inc.
Team Member Laura Chu* Genentech - a member of the Roche Group
Team Member Guneet Walia Genentech - a member of the Roche Group
Team Member Lesley Curtis* Duke University
Team Member Naomi Aronson Blue Cross Blue Shield
Team Member Ani John* Genentech - a member of the Roche Group
Team Member Ken Carson Flatiron
Team Member Cathy Critchlow Amgen
Team Member Ruthie Davi Medidata
Team Member Sarah Leatherman Department of Veterans Affairs
Team Member Jerry Heatley Abbott
Team Member Jessie Juusola Evidation Health
Team Member David Kronfeld Medidata
Team Member John Laschinger Food and Drug Administration
Team Member Eric Peterson Duke University
Team Member David Thompson Syneos Health
Team Member M. Khair ElZarrad FDA/CDER