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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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CTTI Holds Special Event at the FDA to Launch Mobile Technologies Recommendations

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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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