This is your one stop shop for updates on CTTI projects, developments in the clinical trials enterprise and other relevant news. To read the full-length entry, or to share a specific blog post, click on the title of the article of interest.
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CTTI will host a public webinar , Accelerating Evidence Generation: New CTTI Resources for Implementing a QbD Approach to Clinical Trials , on Thurs., Nov. 12.
“We have worked with leaders and all stakeholders across the clinical trials ecosystem to develop new resources that can help research organizations appropriately plan and design clinical trial protocols by implementing , and thus demonstrating the...
A recording is now available of the public webinar held on Tues., Oct. 13, to launch CTTI’s new set of resources that can be used to collaborate, communicate, and design master protocol studies. The webinar was led by Abby Bronson, Edgewise Therapeutics; Marianne Chase, Massachusetts General Hospital; Daniel Millar, Janssen R&D; and Nick Richardson, FDA, CDER.
While the interest in master protocol studies is growing, many organizations—particularly non-traditional drug developers...
Effective engagement between patient groups and research sponsors can enhance the quality and efficiency of clinical trials, improve patient recruitment and retention, reduce costs, and speed the pathway toward new medical treatments. One opportunity for sponsors is to identify and prioritize new effective engagement activities. A new manuscript in Therapeutic Innovation & Regulatory Science details CTTI’s evidence-based prioritization tool to help sponsors and patient groups pinpoint mutually beneficial engagement activities....
The summary report of the web conference on “Stakeholder Engagement on ICH E6 Guidance for Good Clinical Practice,” organized by the U.S. Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI), is now available. The two-day Pan-American web conference was held June 4-5 with more than 1300 attendees worldwide.
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CTTI will host a public webinar on Tues., Oct. 13 to announce new resources that provide a roadmap for designing and running master protocols.
A master protocol approach allows researchers to answer multiple scientific questions within a single clinical trial infrastructure. With a flexible design and highly centralized operational features, the master protocol platform can eliminate several challenges, resources, and expenses associated with developing and running individual...