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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As another successful year comes to a close, CTTI would like to wish you good health and happiness this holiday season and prosperity in the New Year.
We achieved many accomplishments in 2019 thanks to the invaluable input and dedication of members, partners, supporters, and staff, including:
Building on a previous study on the reasons why principal investigators conduct only one FDA-regulated drug trial (“one-and-done” investigators), a new CTTI article published in Contemporary Clinical Trials Communications explores the converse: barriers and critical factors that contribute to “active” investigators’ success while conducting multiple trials.
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A peer-reviewed article highlighting CTTI recommendations for Decentralized Clinical Trials (DCTs) was published this month in Therapeutic Innovation and Regulatory Scienc e. The article describes the process of identifying and addressing the legal, regulatory, and practical hurdles for planning and conducting DCTs.
DCTs, which are run through telemedicine and mobile health care providers, offer several potential advantages, such as faster recruitment...
The FDA’s large portfolio of activities to integrate patient engagement throughout the agency was highlighted during a recent CTTI-hosted webinar, now available to watch online . “Patient Engagement in Action: Insights from Patients & the FDA” was held Thurs., Nov. 21, and featured:
“Patients are at the heart of all FDA...
CTTI has released a new preprint paper describing its recommended approach for identifying and preparing investigators and their delegates to perform clinical research. The paper suggests that by moving beyond Good Clinical Practice (GCP) training as a one-size-fits-all solution, sponsors, CROs, investigators, and other research professionals may be able to more efficiently find and train investigators for quality research.
Specifically, CTTI recommends complementing previous GCP training with a fit-for-...
