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CTTI Project: Registry Trials
Newly released recommendations from the Clinical Trials Transformation Initiative (CTTI) have the potential to streamline clinical trials by using registry information. Registries are data collection tools typically used to better understand long-term trends in a specific population, such as patients with a particular disease or patients exposed to a certain treatment.
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CTTI Project: Registry Trials
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CTTI Project: Registry Trials
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This webinar covers CTTI's recommendations on conducting clinical trials using registries. Those interested in evaluating or designing a registry for the purposes of conducting clinical trials can learn more about the project’s tools, intended for the following purposes:
Download the CTTI Registry Trials Recommendations.
*Mentioned during Q&A: Registry of Patient Registries: patientregistry.ahrq.gov/
*CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. If you use any of the slides from this presentation, please let us know, credit CTTI, and make it clear that you are not presenting on behalf of CTTI.
Embedding clinical trials into patient registries can lead to high-quality, efficient prospective research. However, methods for assessing which registries are appropriate to serve as the platform for the conduct of a clinical trial can be problematic for researchers. A new CTTI paper in Therapeutic Innovation & Regulatory Science identifies and describes the essential characteristics, processes, and practices required to embed and conduct registry-based clinical trials to support regulatory decision-making.
Taking an evidence-based, collaborative approach, CTTI completed a comprehensive review of registry-embedded clinical trials and worked with the Research Triangle Institute (RTI) to conduct 25 expert interviews. These efforts were followed by a multistakeholder meeting with 42 members of academia, industry, government, and patient advocacy organizations.
The resulting data indicates that registries can create a sustainable and reusable infrastructure to support embedded clinical trials when certain characteristics are present including relevancy, robustness, reliability, and assurance of patient protections.
What’s more, registry-embedded clinical trials offer opportunities to:
CTTI noted a prevailing need for guidance on how to assess the suitability of existing registries and plan new registries that can support embedded clinical trials. The paper includes CTTI recommendations, suggested practices, and decision trees that help meet this need. These resources are designed to help clinical trial stakeholders effectively leverage patient registries to create high-quality, embedded clinical trials that benefit relevant patient populations.
CTTI’s newly released recommendations have the potential to streamline clinical trials by using registry information. Registries are data collection tools typically used to better understand long-term trends in a specific population, such as patients with a particular disease or patients exposed to a certain treatment.
“High-quality registries are an increasingly important source of evidence for regulatory decisions and surveillance, conveying important information, for example, regarding real-world medical product use and outcomes throughout the total product lifecycle,” said John Laschinger, MD, of the U.S. Food and Drug Administration, who helped lead the CTTI work. “Use of high-quality registries as a vehicle for efficient conduct of randomized clinical trials is a proven concept that can be considered for future pre-market trials,” he added.
If registries are designed appropriately, the “real-world” data within them should often be able to meet the expectations of regulatory agencies, and support decisions about medical products. In this regard, CTTI addresses how to assess data quality, ensure patient protections, and link with other data sources. The recommendations apply to both existing and new registries. Following these best practices can assist in evaluating suitability of registry data for regulatory purposes.
“Conducting randomized clinical trials within registries can increase efficiencies in data collection and decrease site workload, potentially leading to significant cost savings,” said Sunil Rao, MD, principal investigator of the successful randomized registry-based clinical trial, SAFE-PCI for Women.
While the scope of this project was limited to registries, many of the principles and tools in these recommendations have the potential to be applied to using health care systems or other existing data sources, such as those available within claims databases, to facilitate more efficient clinical trials.
More information about these recommendations on conducting clinical trials using registries is available both on the Registry Trials Project page and in a webinar recording.
*To view the press release of this announcement, click here.
You’re headed to Liverpool, take this printable one page schedule of CTTI’s presentations at the meeting. See you there!
CTTI will present its recommendations and latest findings in five sessions at the International Clinical Trials Methodology Conference (ICTMC) and Society for Clinical Trials (SCT) Annual Meeting, May 7-10, 2017. We will lead a hands-on workshop on best practices for Data Monitoring Committees, and share our evidence and strategies on embedding randomized clinical trials within registries, developing novel endpoints generated by mobile technology, and more.
Session Title: Formative Research Findings on the Design of an Early Enrollment Clinical Trial on Hospital Acquired Bacterial Pneumonia (HABP) and Ventilator Associated Bacterial Pneumonia (VABP) (Parallel Session 1.5 – Qualitative Research)
Date & Time: Monday May 8 from 1:30–2:30 p.m.
Speaker: Amy Corneli, Duke University
Related CTTI Project: HABP/VABP Studies
Post/our-work/novel-clinical-trial-designs/antibiotic-drug-development/abdd-habp-vabp-studies/er Abstract: Embedding Randomized Clinical Trials within Registries: How Feasible? (Poster Board #152)
Date & Time: Monday, May 8 from 3:40–4:25 p.m.
Speaker: Ted Lystig, Medtronic
Related CTTI Project: Registry Trials
Poster Abstract: Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials: A Clinical Trials Transformation Initiative (CTTI) Project (Poster Board #153)
Date & Time: Monday, May 8 from 3:40–4:25 p.m.
Speaker: Martin Landray, University of Oxford
Related CTTI Project: MCT Novel Endpoints
Workshop Title: Data Monitoring Committees: Multi-stakeholder Recommendations and Hands-on Experience from CTTI and the MRCT Center (Workshop 3)
Date & Time: Tuesday, May 9 from 8:30–10:00 a.m.
Speaker: Annemarie Forrest, CTTI
Related CTTI Project: DMCs
Panel: Clinical / Outcomes Registry-Based Randomised Controlled Trials – The Future for Clinical Trials? (Invited Session 3.5)
Date & Time: Tuesday, May 9 from 8:30–10:00 a.m.
Speaker: Ted Lystig, Medtronic
Related CTTI Project: Registry Trials
