Press Releases

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.

PDF icon Download Press Release (73.95 KB)

CTTI Releases Recommendations for Engaging Patients and Sites in Mobile Clinical Trials

[yoast-breadcrumb]

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.

PDF icon Download Press Release (486.5 KB)

CTTI and FDA Convene Workshop on Including Patient Perspectives in Clinical Trials

[yoast-breadcrumb]

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.

PDF icon Download Press Release (262.53 KB)

CTTI to Support NIH Workgroup in Developing Evaluation Plan for Single IRB Policy

[yoast-breadcrumb]

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.

PDF icon Download Press Release (128.03 KB)

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

[yoast-breadcrumb]

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.

PDF icon Download Press Release (134.56 KB)

CTTI and the FDA Select Representatives for Patient Engagement Collaborative

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.

PDF icon Download Press Release (280.48 KB)