CTTI Project: Developing Novel Endpoints, Planning Decentralized Trials
Today the Clinical Trials Transformation Initiative (CTTI) announced a new online Digital Health Trials Hub featuring enhanced recommendations and additional resources.
Press Releases
Coalition to Transform Clinical Trials Names Executive Board
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The Clinical Trials Transformation Initiative (CTTI) has named a 12-member Executive Board that will oversee its activities.
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CTTI Addresses Pregnancy Testing Challenges in Clinical Trials with New Recommendations and Online Tool
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CTTI Project: Pregnancy Testing
The Clinical Trials Transformation Initiative (CTTI) today released new recommendations and an online tool to help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans, in an effort to conduct safer, more efficient clinical trials.
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CTTI Seeks to Speed Use of Mobile Technology in Clinical Trials through Novel Endpoint Recommendations
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CTTI Project: Developing Novel Endpoints
Mobile technologies hold enormous promise for clinical research, but uncertainty about how to use the data captured by these devices has slowed progress. CTTI's newly released recommendations and tools aim to change this by providing a pathway for using information gathered from mobile technologies to accelerate the development and evaluation of urgently needed therapies.
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Clinical Trials Transformation Initiative Releases New Recommendations to Improve Studies of Antibacterial Drugs for Children
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CTTI Project: ABDD Peds Trial
Challenges in conducting antibacterial drug trials for pediatric patients can delay the safe and effective use of treatments for this vulnerable group. CTTI’s new recommendations for making pediatric antibacterial trials more successful. These practical, evidence-based strategies can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric antibacterial trials or pediatric trials in other therapeutic areas.
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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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CTTI to Support NIH Workgroup in Developing Evaluation Plan for Single IRB Policy
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CTTI Project: Single IRB
The National Institutes of Health (NIH) has selected the Clinical Trials Transformation Initiative (CTTI) to support a workgroup that will develop a comprehensive plan for assessing the NIH’s new single institutional review board (sIRB) policy. The policy, which became effective in January, requires U.S. sites participating in nonexempt multicenter human subjects research funded by the NIH to use a sIRB for ethical review, with the goal of improving the quality and efficiency of clinical research.
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