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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 Project: Supporting Decentralized Trial Approaches
A collaborative research team established by the Clinical Trials Transformation Initiative (CTTI) created a new tool and recommendations to improve the efficiency and quality of multi-center 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 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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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 Project: Safety Reporting
Despite legal and ethical mandates for disclosure, results from most clinical trials of medical products are not reported promptly on a registry specifically created to make results of human studies publically available, according to Duke Medicine researchers.
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CTTI Project: Patient Engagement
As part of an effort to improve the way clinical trials are conducted, the Clinical Trials Transformation Initiative (CTTI) has formed a 16-member council to engage patient advocates in its mission.
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CTTI Project: Recruitment
CTTI has released new recommendations and tools for enhancing the efficiency of clinical trial recruitment that are now available to download. Patient recruitment is a leading challenge in the efficient completion of clinical trials, which can result in wasted resources and delays in bringing new therapies to market. The foundational principle for this new approach is that recruitment planning should be started earlier in the clinical trial development process and continue throughout the implementation.
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CTTI Project: ABDD Peds Trials
The number of clinical trials enrolling children is far lower than for adults, and the scope of research is also narrower, according to an analysis of public-access data conducted by researchers at Duke University.
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CTTI Project: State of Clinical Trials
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