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New Executive Committee Members Named to Clinical Trials Transformation Initiative (CTTI)
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The Clinical Trials Transformation Initiative (CTTI) has named new members to its Executive Committee, expanding the breadth of expertise for leaders advising CTTI on its strategy for transforming clinical research.
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Results and Recommendations: New Recommendations from Public-Private Partnership Aim to Improve Clinical Trial Quality and Safety
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A public-private partnership comprising over 60 organizations has announced recommendations to improve clinical trials by ensuring quality with effective and efficient monitoring and improving safety through better methods of reporting unexpected serious adverse events to investigators.
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First Report from Public-Private Partnership Shows Variability in How Clinical Trials Are Monitored
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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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New CTTI Recommendations Provide Path for More Efficient Clinical Trials Using Clinical Registries
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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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Study Shows Clinical Trials Fall Short of High-Quality Evidence Needed To Guide Medical Decision-Making
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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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Clinical Trials Transformation Initiative Releases Recommendations to Enhance the Feasibility of Developing New Antibacterial Drugs
CTTI Project: ABDD Streamlining HABP/VABP
CTTI’s two new sets recommendations outline innovative approaches to designing clinical trials for HABP/VABP, including early enrollment strategies and the streamlined collection of safety data. CTTI convened multi-stakeholder teams to analyze the challenges associated with HABP/VABP trials and develop the proposed solutions. The feasibility of these new approaches will be tested in an upcoming pilot study, the findings of which are expected to help drive adoption of streamlined practices for antibacterial drug development across the clinical trial enterprise.
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CTTI Releases New Recommendations and Resources for Using Real-World Data to Plan Trial Eligibility Criteria and Recruit Participants
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CTTI Project: Real World Data
During a public webinar today, the Clinical Trials Transformation Initiative (CTTI) will release new recommendations and resources on how to use real-world data (RWD) to evaluate trial eligibility criteria and recruit potential research participants.
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CTTI Releases Recommendations for Engaging Patients and Sites in Mobile Clinical Trials
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CTTI Project: Preparing a Site
During a public webinar today, the Clinical Trials Transformation Initiative (CTTI) will release new recommendations and resources for engaging patients and research sites when planning and conducting mobile clinical trials. By doing so, sponsors, contract research organizations, and other stakeholders can maximize the opportunities of mobile technologies to advance the development of new medical products.
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CTTI and FDA Convene Workshop on Including Patient Perspectives in Clinical Trials
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CTTI Project: Patient Group Engagement
The Clinical Trials Transformation Initiative (CTTI) will convene a public workshop, “Enhancing the Incorporation of Patient Perspectives in Clinical Trials," in collaboration with the U.S. Food and Drug Administration (FDA) on Mon., March 18, from 9:00 a.m. to 5:00 p.m. at the Tommy Douglas Conference Center in Silver Spring, Md.
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