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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: 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: Patient Group Engagement
Potential participants in clinical trials may not have a clear understanding of the methods used by researchers to ensure the safety of investigational drugs they are given.
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CTTI Project: Supporting Decentralized Trial Approaches
The Clinical Trials Transformation Initiative (CTTI) will unveil new recommendations to speed the use of decentralized clinical trials (DCTs)—trials run through telemedicine and mobile health care providers—today at the DPharm: Disruptive Innovations to Advance Clinical Trials conference in Boston, Mass.
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CTTI Project: Digital Health Trials
In a special event at the U.S. Food and Drug Administration (FDA) today, the Clinical Trials Transformation Initiative (CTTI) will unveil recommendations for the use of mobile technologies in clinical research. The evidence-based recommendations and resources address an unmet need by outlining best practices for the use of mobile devices and applications to capture objective data—an approach that has the potential to increase the quality and efficiency of clinical trials.
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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 Engagement Collaborative
The Clinical Trials Transformation Initiative (CTTI) and the U.S. Food and Drug Administration (FDA) announced newly selected representatives for the Patient Engagement Collaborative (PEC) today. The group of 16 patients, caregivers, and patient group representatives will meet with the FDA several times a year to discuss topics such as communication, transparency, and the best ways for patients to participate in the FDA’s regulatory discussions about medical products.
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In a public Celebration Symposium on Feb. 6, leaders from across the clinical trials enterprise will gather to celebrate CTTI's 10-year anniversary. The exciting lineup of speakers will share case studies illustrating the benefits of applying CTTI’s clinical trial recommendations and moderate a vibrant exchange of ideas on the future of the clinical trials enterprise.
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CTTI Project: Patient Engagement Collaborative
CTTI has been engaged by the U.S. Food and Drug Administration (FDA) to support its Patient Engagement Collaborative (PEC), an effort created in partnership with CTTI to bring together members of the patient community to discuss the best ways for patients to participate in the FDA’s regulatory discussions about medical products.
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