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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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...
Today, at the ESC Congress 2020 – The Digital Experience , a group of U.S. investigators from several organizations including CTTI announced their collaborative findings from the Implementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib) trial.
CTTI worked with Aetna, Duke Clinical Research Institute, the Harvard Pilgrim Health Care Institute's Department of Population Medicine, Harvard Pilgrim...
Digital health technologies offer the potential to improve the conduct of clinical trials. If harnessed correctly, they can reduce patient burden, streamline operations, and optimize data collection. The key to unlocking these benefits is to ensure that patient and site perspectives are considered during the planning process. CTTI has released a new manuscript in Contemporary Clinical Trials Communications that features the first evidence-based set of recommendations for incorporating patient and site perspectives in digital health trials....
A new CTTI paper, detailing its findings from a project designed to assess challenges and burdens associated with Good Clinical Practice (GCP) training, has published in Contemporary Clinical Trials Communications.
The paper, " More than a Box to Check: Research Sponsor and Investigator Perspectives on Making GCP Training Relevant ," outlines feedback on GCP training gleaned from interviews CTTI conducted with clinical...