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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A recent CTTI webinar brought together stakeholders from across the clinical trials enterprise for an overview of Quality by Design (QbD), existing CTTI resources, and how QbD is being implemented in the real world.
QbD is defined as the absence of “errors that matter”—or, those errors that could jeopardize the ability to 1) protect patients during the trial, and 2) obtain reliable results and meaningful information from the trial. CTTI started working on QbD in 2011, with a focus on addressing ineffective clinical trial...
The FDA, in collaboration with CTTI, convened the second in-person meeting of the Patient Engagement Collaborative (PEC) in March at the FDA’s White Oak Campus in Silver Spring, Md. A summary of the meeting is now available .
The primary objective of the PEC’s most recent meeting was to discuss a “how-to guide” to help patients and patient groups navigate engaging with the FDA. Ideas for new resources included a patient ambassador training program and informational marketing campaigns to meet patients where they live and work...
A video recording , presentations, and other materials from the March 18 workshop, “Enhancing the Incorporation of Patient Perspectives in Clinical Trials,” are now available. This workshop, offered in collaboration with the FDA, gathered input from patients, caregivers, industry, academic researchers, and expert practitioners on the challenges and barriers to patient participation in clinical trials.
Session-by-session videos are also available:
A new article in Clinical Trials, co-authored by CTTI, outlines lessons learned from the planning phase of the implementation of a randomized controlled trial to improve treatment with oral anticoagulants in patients with Atrial Fibrillation (IMPACT-AFib) trial, the first large pragmatic clinical trial that used the Sentinel infrastructure. This work is part of CTTI’s larger effort to advance trials that use real world data sources.
The FDA’s Sentinel System uses electronic...
A recording is now available of the public webinar on Thurs., Feb. 21, to launch CTTI’s new recommendations for incorporating patient and site perspectives in mobile clinical trials. The webinar was led by patient advocate Cindy Geoghegan and Virginia Nido of Genentech, a member of the Roche Group.
CTTI conducted qualitative and quantitative research to better understand the perceptions of patients and site personnel, and convened experts and leaders across the clinical trials...