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Clinical Trials Transformation Initiative (CTTI)

 

The Clinical Trials Transformation Initiative (CTTI) is a public private partnership with Duke University and FDA with a mission to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. Target Health has been a member of the Steering Committee since 2008, and Dr. Mitchel had the honor, between 2014-2015, to sit on the Executive Committee, representing the Steering Committee.

 

This past week, the Steering Committee met in D.C. with the theme of how to implement CTTI recommendations. It was a very stimulating meeting that included presentations and breakout sessions. Our take-away of the meeting is that it will take leadership and ownership to make the changes needed to completely modernize the clinical trial enterprise. All agreed that we look forward to examples of how CTTI companies are implementing changes.

 

At Target Health, the impact of CTTI has been in the area of managing clinical trials using principles of Quality by Design, and our approach to risk-based monitoring, based on the publication of the CTTI Monitoring Survey Project: Monitoring the Quality of Conduct of Clinical Trials: A Survey of Current Practices.

 

Target Health was also a key team member in CTTI’s Registry Trials Recommendations that has provided a pathway for registries to be used for the conduct of more efficient clinical trials, bringing new treatments to patients faster. 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 exposure to a certain treatment. However, if designed appropriately, registries can be used as a data source within which clinical trials can be performed. FDA recently signaled a commitment to developing policies regarding the use of registries and other forms of “real-world evidence“ for research, including clinical trials. While registries have long been used to support safety evaluations, their use for efficacy evaluations is a newer practice. CTTI’s recommendations outline best practices for assessing and designing registries so that the data should be able to meet expectations for FDA review of new products. The recommendations can be applied to existing registries or for developing new registries. The goal is to increase the practice of leveraging registries to facilitate high-quality clinical trials at lower costs.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

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