This is your one stop shop for updates on CTTI projects, developments in the clinical trials enterprise and other relevant news. To read the full-length entry, or to share a specific blog post, click on the title of the article of interest.
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CTTI will host a public webinar on Thurs., Feb. 21, to announce new recommendations and resources for incorporating patient and site perspectives when planning and conducting mobile clinical trials.
“Acceptance and adoption by key stakeholders is critical to the widespread use of mobile technologies in clinical trials,” said CTTI Executive Director Pamela Tenaerts. “However, very little was known about patient and sites’ perspectives until our work shed light on what they see as...
The FDA, in collaboration with CTTI, convened the inaugural meeting of the newly formed Patient Engagement Collaborative (PEC) in August at the FDA’s White Oak Campus in Silver Spring, Md. A summary of the meeting is now available .
The PEC is a joint initiative of the FDA and CTTI. Its 16 members, selected from nearly 200 patients and advocates, are helping expand the FDA’s efforts to achieve meaningful patient engagement in medical...
A CTTI article recently published in JAMA Network Open shows that an early enrollment strategy for research on health care-associated pneumonia is acceptable to patients, investigators, and institutional review boards (IRBs). This strategy has the potential to speed enrollment in trials for critical new antibiotic therapies by allowing patients to be approached and consented before being diagnosed with pneumonia.
Through its ABDD HABP...
The NIH has selected 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.
“For nearly a decade...
The Reagan-Udall Foundation for the FDA presented CTTI with the Innovations in Regulatory Science Award on Tues., Dec. 4, in recognition of its achievements and continued contributions to regulatory science. CTTI was one of three recipients of the annual award.
“This great honor caps off a momentous year for CTTI,” said Pamela Tenaerts, CTTI executive director. “We celebrated our 10-year anniversary at the beginning of...
