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Results from a study assessing how clinical trial quality is monitored in the U.S. reveal a variety of monitoring approaches, the choice of which appears to relate to the type of organizational sponsor for the trial.
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CTTI Project: Registry Trials
Newly released recommendations from the Clinical Trials Transformation Initiative (CTTI) have the potential to streamline clinical trials by using registry information. Registries are data collection tools typically used to better understand long-term trends in a specific population, such as patients with a particular disease or patients exposed to a certain treatment.
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The largest comprehensive analysis of ClinicalTrials.gov finds that clinical trials are falling short of producing high-quality evidence needed to guide medical decision-making.
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The Clinical Trials Transformation Initiative (CTTI) has named a 14-member Executive Committee, resetting CTTI’s strategic direction, and ensuring that the organization informs and facilitates meaningful improvements to clinical trial design and conduct.
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CTTI Project: Electronic Healthcare Data
Today, at the ESC Congress 2020 – The Digital Experience, a group of U.S. investigators from several organizations 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), the first trial to use the U.S. Food and Drug Administration’s (FDA) FDA-Catalyst System network of electronic health data from a diverse group of national health plan data partners.
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CTTI Project: Quality by Design
CTTI has issued recommendations and an associated toolkit to improve the quality and efficiency of clinical trials by helping sponsors to focus on study activities that are essential to the safety of trial participants and the reliability of study results, and to reduce or eliminate those activities that are not.
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CTTI Project: Investigator Community
The Clinical Trials Transformation Initiative (CTTI) has announced recommendations to streamline Good Clinical Practice (GCP) training of investigators who participate in clinical trials.
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CTTI Project: State of Clinical Trials
Research for diabetes is far more focused on drug therapies than preventive measures, and tends to exclude children and older people who have much to gain from better disease management, according to a Duke Medicine study.
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The U.S. Food and Drug Administration and Duke University Medical Center have begun a collaboration aimed at modernizing the way clinical trials are conducted.
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