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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Using a single institutional review board (sIRB) for multisite trials can improve the quality and efficiency of multicenter clinical trials—and beginning Jan. 25, 2018, the National Institutes of Health (NIH) is requiring use of an sIRB for NIH-funded multicenter clinical research.
To help drive adoption of sIRB review, CTTI has developed several recommendations, resources, and tools for use by the research community, and recently convened an expert meeting to discuss further actions that CTTI, the U.S. Food and Drug Administration (FDA), Office for Human Research Protections (OHRP...
Ken Getz, director of sponsored research programs and research associate professor, Tufts Center for the Study of Drug Development, Tufts University, offered his insights on patient engagement at CTTI’s 10-year Anniversary Symposium on Tues., Feb. 6. He shares those thoughts here in a special guest blog.
As a veteran observer and analyst of the clinical research enterprise, I am very proud of and amazed by the extent to which the patient engagement movement has touched the entire continuum of new medical interventions development.
New services have been created...
Clinical Trials featured a supplement in its March 2018 issue (available online now) celebrating a decade of CTTI’s impact on clinical trials. The supplement includes articles on CTTI’s accomplishments and lessons learned over the last 10 years, its unique methodology, its work to promote patient engagement and clinical trial quality, and the role it can play in addressing ongoing and future challenges. All supplement articles are freely accessible.
Since its inception in 2007, CTTI has conducted more than 25 projects and issued recommendations for strategies to enhance...
In a symposium held Feb. 6, more than 150 attendees, including leaders from across the clinical trials enterprise, gathered to celebrate CTTI’s 10-year anniversary and discuss how CTTI’s work has led to improvements in clinical trials. Highlights from the day included a keynote address by Robert Califf, former FDA commissioner, and engaging panels with stakeholders from across the enterprise on topics including quality by design (QbD), patient engagement, use of a single IRB of record, and the future of clinical trials.
Clinical Trials Reflections & Predictions ...
In an article recently published in the Journal of the Pediatric Infectious Disease Society (JPIDS), CTTI researchers lay out a roadmap for addressing an urgent public health issue: pediatric antibacterial drug development.
Antibacterial drugs are critically important for treating infectious diseases, but growing rates of antimicrobial resistance have made the development of new antibacterial therapies a priority for researchers and physicians. The problem is especially acute in pediatrics, because even when new drugs are developed for adults, it may be up to 10 years...