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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Integrating trials that are intended for medical product review into clinical health care offers the promise of data that reflect real-world populations and settings, and improve efficiency by avoiding duplication of activities that already occur in clinical care. However, there are currently no guidelines or strategies to help clinical trial stakeholders operationalize this fit-for-purpose integration.
To remedy this issue, CTTI is starting work on a new...
One of many ways that CTTI engages with and integrates patients into our work is by having patient/caregiver representatives on our Steering Committee. Now, through 11:59 p.m. ET, Sun., Nov. 22, we are accepting applications for this position . We are looking for patients or caregivers who are self-starters, have personal experience and familiarity with clinical trials, and can work with stakeholders across the research community.
During their three-year term, CTTI Steering...
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....