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.
Quick Links to Top Deliverables
Real-World Data and Evidence in the Evaluation of Medical Products
Expert Meeting SummaryExpert Meeting Materials
June 12-13, 2018 Materials, including the summary and presentations from the expert meetingResource
Establishing Use of RWD as a Standard Process in Study Planning and RecruitmentResource
Evaluating Whether RWD Is Suitable for Planning Eligibility Criteria and Supporting RecruitmentResource
Effective RWD-Supported Discussions of Eligibility CriteriaResource
Evaluating Feasibility of RWD-Supported RecruitmentIn 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”) (2017–2019)
- 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 |
Name |
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 |