July 21, 2017: CTTI Registry Trials Project: Evaluation and Design of Registries for Conducting Clinical Trials


John Laschinger, MD, FDA and Jules Mitchel, MBA, PhD, Target Health


CTTI Registry Trials Project: Evaluation and Design of Registries for Conducting Clinical Trials


Pragmatic clinical trial; Clinical research; Clinical trial registries, CTTI

Key Points

  • Stakeholder collaboration to leverage patient registries for quality trials will result in maximum impact in clinical research
  • Patient protections, interoperability, and data quality are key considerations for designing registry-embedded clinical trials
  • CTTI recommendations for existing registries include evaluation of historical evidence for quality and privacy/security elements on a suitable platform.
  • Recommendations also include following industry and regulatory guidelines and creating methods for compliance in real-world use
  • Relevancy, reliability, and robustness are key factors in suitability of registry for regulatory purposes and reuse across clinical trials

Discussion Themes

The beauty of a registry is that the majority of the data needed is already there, and it does not have to be recreated from scratch.

Patient-reported outcomes and patient-centered outcomes that are in the older registries were likely not designed in partnership with patients so there should be some mechanisms for assessing that.

Facilitating bidirectional engagement by moving registries to platforms is necessary for optimizing patient engagement in research.

Overcoming barriers to using existing registry data use starts with changing the approach to adoption through demonstration projects and unified commitment among stakeholders.

Cost and sustainability are major considerations when building registries because of user management and maintenance, but if created thoughtfully, these registries can be used efficiently.

For More Information

To learn more about the CTTI Registry Trials Project, visit https://www.ctti-clinicaltrials.org/projects/registry-trials

@DCRI, @CTTI_Trials, @Collaboratory1, @US_FDA, @TargetHealthInc, #clinicaltrials, #pctGR

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