Speakers
Sudha Raman, PhD, MA
Assistant Professor
Department of Population Health Sciences
Duke University
John Sheehan, PhD, MBA, RPh
Senior Director, Value and Evidence (HEOR) Neuroscience
Janssen Scientific Affairs, LLC
Topic
Using Real-World Data to Plan Eligibility Criteria and Enhance Recruitment: Actionable Recommendations and Resources from the Clinical Trials Transformation Initiative
Keywords
Clinical Trials Transformation Initiative (CTTI); Real-world data (RWD); Recruitment planning; EHR; Eligibility criteria; Fit-for-purpose data
Key Points
- Real-world data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected by a variety of sources.
- CTTI provides recent recommendations, resources, and case studies that highlight actionable tools and best practices for evaluating and using real-world data (RWD) in clinical trial recruitment activities:
- General principles for using RWD
- Using RWD to plan eligibility criteria
- Using RWD to support recruitment
- Enhancing RWD capabilities for the research enterprise
- Using RWD from data sources such as electronic health records and claims data brings challenges for completeness, accuracy, and generalizability of the data.
- RWD holds the potential to increase patient eligibility and enrollment as well as reduce recruitment timelines.
Discussion Themes
Insights from RWD should be sought early in the product lifecycle and include context from patients and sites.
One challenge of RWD data sources is finding appropriate databases for the disease area of interest, especially for trials of rare diseases.
Are there lessons learned about when using RWD becomes prohibitive or too expensive?
Read and download CTTI’s recommendations for using RWD. Learn more about FDA’s guidance for real-world data and real-world evidence. A publication is available about the health plan recruitment method used in the ADAPTABLE aspirin study.
Tags
#pctGR, @Collaboratory1