July 31, 2020 Using RWD to Plan Eligibility Criteria & Enhance Recruitment Sudha Raman, Duke Department of Population Health Sciences Jack Sheehan, Janssen Scientific Affairs
Disclaimer The views and opinions expressed in this presentation are those of the individual presenter and do not necessarily reflect the views of the Clinical Trials Transformation Initiative, Duke University, or Janssen Scientific Affairs.
Public-Private Partnership Co-founded by Duke University & FDA Involves all stakeholders - Approx. 80+ members - Participation of 400+ more orgs MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials
Meeting Recruitment Challenges Discovery's 'First In Human' Calls Much-Needed Attention To Clinical Trials
CTTI Real-World Data (RWD) Project Team Executive Committee Champions: Team Members: Richard Platt, Harvard Naomi Aronson, Blue Cross Blue Shield Barbara Bierer, Harvard Joe Selby, PCORI William Capra, Genentech* Ken Carson, Flatiron Team Leaders: Laura Chu, Genentech* Lesley Curtis, Duke* Cathy Critchlow, Amgen Scott Evans, Society for Clinical Trials Ruthie Davi, Medidata Dianne Paraoan, FDA/CDER Kristin Dolinski, PhRMA Jane Perlmutter, Patient/Caregiver M. Khair ElZarrad, FDA/CDER Sudha Raman, Duke Ryan Ferguson, Dept of Veterans Affairs Melissa Robb, FDA/CDER* Farhan (CJ) Hameed, Pfizer Jack Sheehan, Janssen Jerry Heatley, Abbott Ani John, Genentech* Jessie Juusola, Evidation Health CTTI Staff: David Kronfeld, Medidata* Zachary Hallinan (Project Management) John Laschinger, FDA/CDRH* Gerrit Hamre (Project Management)* Sarah Leatherman, Dept of Veterans Affairs Lindsay Kehoe (Project Management) Claire Meunier, Evidation Health* Brian Perry (Social Science) Eric Peterson, Duke Laura Shannon (Communications) Estevan Santana, PhRMA David Thompson, Syneos Health Juli Tomaino, FDA/CDER* * Indicates former Guneet Walia, Genentech
Evolution of Gauging Public Opinion Straw Poll Telephone Poll
Real World Data (RWD) Recommendations GENERAL RECS FOR RECS FOR RECS FOR PRINCIPLES USING RWD TO USING RWD ENHANCING RWD FOR USING PLAN FEASIBLE TO SUPPORT CAPABILITIES FOR RWD ELIGIBILITY RECRUITMENT THE RESEARCH CRITERIA ENTERPRISE
Data Sources EHR Claims Data richness / depth Fully structured Clinical info Widespread availability Faster availability Continuum of data Integration with routine capture health care COMMON CHALLENGES Data completeness, data accuracy, & generalizability
GENERAL RECS FOR RECS FOR RECS FOR PRINCIPLES USING RWD TO USING RWD ENHANCING RWD FOR USING PLAN FEASIBLE TO SUPPORT CAPABILITIES FOR RWD ELIGIBILITY RECRUITMENT THE RESEARCH CRITERIA ENTERPRISE Start early in product lifecycle Engage patients & sites Data alone never tell whole story Build cross-functional teams
Resource: Establishing Use of RWD as Standard Process in Study Planning & Recruitment • Engage study teams as early as possible • Demonstrate value (e.g., case studies) Early • Pilot with early phase / feasibility trials Stages • Leadership understanding & support • Identify and maintain data sources (consider budgets, priorities, & responsibilities) Standard • Support cross-functional teams Process
GENERAL RECS FOR RECS FOR RECS FOR PRINCIPLES USING RWD TO USING RWD ENHANCING RWD FOR USING PLAN FEASIBLE TO SUPPORT CAPABILITIES FOR RWD ELIGIBILITY RECRUITMENT THE RESEARCH CRITERIA ENTERPRISE Evaluate RWD against particular needs of study Use RWD to test important assumptions Plan iterative team discussions Starting early in study design
Tool: Is the Data Fit-for-Purpose? Important eligibility criteria identifiable? • Directly or via proxy measures • Structured and unstructured data Data of sufficient relevance & quality? • Acceptability of errors in data • Recency relative to study needs • Generalizability Analysis cost-effective? • Number of databases • Challenges in pooling data
Tool: Effective RWD-Supported Discussions Engage Adjust Study Define Cross- Design & Fundamental Functional Mitigate Parameters Team Risks Including… Identify and plan for… For example… • Study objectives • Risks associated with non- • Clinical • • Key endpoints negotiable eligibility criteria Operations • Impact of changing other • • High-level eligibility Informatics proposed eligibility criteria • criteria Epidemiology • Outside factors impacting • • Likely operational Patients feasibility • challenges Investigators
Case Study: Using RWD to Expand Eligibility Criteria for Phase III Endocrinology Study As part of a broader strategic initiative, the sponsor saw: 33% 71% 2.1 month Increase in Increase in Reduction in PATIENT ENROLLMENT RECRUITMENT ELIGIBILITY RATES TIMELINES Additional case studies available at https://www.ctti-clinicaltrials.org/projects/real-world-data
GENERAL RECS FOR RECS FOR RECS FOR PRINCIPLES USING RWD TO USING RWD ENHANCING RWD FOR USING PLAN FEASIBLE TO SUPPORT CAPABILITIES FOR RWD ELIGIBILITY RECRUITMENT THE RESEARCH CRITERIA ENTERPRISE Start with realistic eligibility criteria Incorporate RWD-supported recruitment whenever feasible Understand needs of patients & sites
Tool: Evaluating RWD for Recruitment Granularity Pathways for contacting patients Adequate matching Sufficient recency Local context Manual screening
Tool : Planning RWD-Support Recruitment Identify Communication Channels E.g., email or letter from E.g., conversation with insurance company or physician prompted by research hospital EHR pop-up Casts widest possible net Complex eligibility criteria Main challenge is finding Highly sensitive enough participants discussions (e.g., mortality) Appropriate intermediary Narrow window of eligibility not available Patients have strong connection to care provider
Evolution of Gauging Public Opinion Straw Poll Telephone Poll Robocalls
GENERAL RECS FOR RECS FOR RECS FOR PRINCIPLES USING RWD TO USING RWD ENHANCING RWD FOR USING PLAN FEASIBLE TO SUPPORT CAPABILITIES FOR RWD ELIGIBILITY RECRUITMENT THE RESEARCH CRITERIA ENTERPRISE Data linkage Transparency & data usage Global data sets Communication Technology channels development Participant diversity Best practices
Now Available Full Recommendations 5 Actionable Tools Establishing Use of RWD as a Standard Process in Study Planning and Recruitment Evaluating Whether RWD Is Suitable for Planning Eligibility Criteria and Supporting Recruitment Effective RWD-Supported Discussions of Eligibility Criteria Evaluating Feasibility of RWD- Supported Recruitment Planning RWD-Supported Recruitment Strategies 3 Case Studies Download at www.ctti-clinicaltrials.org/projects/real-world-data
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