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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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...
During a public webinar on Thurs., Nov. 15, CTTI released new recommendations that propose a fresh approach for investigator qualification. The webinar, now available online , explored how these new recommendations can move qualification activities beyond repetitive one-size-fits-all training to include individual experience and protocol-specific preparation.
While current FDA regulations state that sponsors and their delegates are responsible for selecting qualified investigators, no guidelines exist for how...
