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 ecosystem.

Use of Real-World Data to Plan Eligibility Criteria and Enhance Recruitment (“Real-World Data”) (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)

Organization affiliations are listed as active affiliations during the project.

*Indicates former project manager, team leader, or team member.