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 use of real world evidence (RWE)—derived from sources such as electronic health records (EHR) and claims data—has the potential to provide a more complete picture of patient experiences, reduce costs, and offer unique insights into important scientific questions. At the same time, there are relatively few examples to inform efforts to integrate RWE into clinical trials, as well as a lack of consensus among researchers about valid approaches for leveraging these data sources.
To...
Most clinical trials exclude pregnant women in order to minimize risk to the embryo or fetus. However, there are currently no specific guidelines for how pregnancy testing should be conducted for female trial participants of reproductive potential, nor how risks should be clearly communicated with them.
In a recent article in PLOS ONE, CTTI shares recommendations developed by experts in academia, industry, and regulatory agencies on pregnancy testing in clinical research. They...
CTTI will share its new recommendations for incorporating mobile technology into clinical trials during an upcoming FierceMarkets webinar on Thurs., Oct. 11, at 2:00 p.m. ET. During this webinar, experts will explain how and when to use mobile devices and applications to capture more informative real-world data from patients, reduce barriers to trial participation, lower costs, and speed the timelines associated with conducting clinical trials.
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In an article recently published in Pediatrics , CTTI researchers assess the impact of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) on pediatric antibacterial and antifungal drug trials.
The study, which evaluated pediatric trials conducted between 2007 and 2017, found that nearly two-thirds of pediatric antibacterial and antifungal drug trials were conducted under BPCA or PREA. These trials were more likely to collect...
Experts Unveil New CTTI Recommendations and Resources at FDA’s White Oak Campus
During a daylong launch event at the U.S. Food and Drug Administration’s (FDA) White Oak Campus, more than 100 people—along with hundreds of virtual attendees—learned about CTTI’s newly release recommendations and resources for the use of mobile technologies in clinical trials.
The evidence-based recommendations and resources...