On March 30, 2016, CTTI’s Registry Trials Project held a multi-stakeholder expert meeting to accomplish the following:

• Identify essential elements of registries needed to successfully embed and conduct registry-based clinical trials
• Present findings from the project’s literature review and expert interviews
• Receive feedback on potential benefits of and existing barriers to the use of registries in clinical trials
• Reach consensus on best practices to increase adoption of clinical trials within registries

The meeting included more than 40 participants from academia, government agencies, industry, and patient representatives. A key takeaway was that a role exists for registries in creating a sustainable infrastructure to conduct regulatory trials, including early development, pre-market, and post-approval investigations. Suggestions were generated around considerations including data quality, regulatory issues, governance, and registry design. Input from the meeting, along with evidence gathered through the CTTI project, will be used to develop recommendations and tools to increase the value, acceptance, and success of registry-based clinical trials.

CLICK HERE to access the meeting summary, slides, agenda, and other materials.