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The FDA’s large portfolio of activities to integrate patient engagement throughout the agency was highlighted during a recent CTTI-hosted webinar, now available to watch online . “Patient Engagement in Action: Insights from Patients & the FDA” was held Thurs., Nov. 21, and featured:
“Patients are at the heart of all FDA...
CTTI has released a new preprint paper describing its recommended approach for identifying and preparing investigators and their delegates to perform clinical research. The paper suggests that by moving beyond Good Clinical Practice (GCP) training as a one-size-fits-all solution, sponsors, CROs, investigators, and other research professionals may be able to more efficiently find and train investigators for quality research.
Specifically, CTTI recommends complementing previous GCP training with a fit-for-...
The open access journal Digital Biomarkers published a new article this week featuring CTTI recommendations for the use of Mobile Technologies for Data Capture and Improved Clinical Trials . The article articulates the vision of using mobile technologies in clinical trials and highlights CTTI’s evidence-based solutions for using mobile technologies for more efficient assessment of new therapies for patients.
Mobile technologies such...
IMPACT-AFib (IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation) is a nationwide pragmatic clinical trial launched in 2017 by collaborators including CTTI. IMPACT-AFib is the first trial conducted under FDA-Catalyst, which incorporates the infrastructure of the FDA’s Sentinel System and enables direct contact with health plan members and providers. To help facilitate large-scale interventional research more efficiently, the collaborators followed CTTI’s...
A summary of the most recent meeting of the Patient Engagement Collaborative (PEC) is now available. The PEC, which is convened jointly by the FDA and CTTI to discuss how the FDA can bolster patient engagement in its activities, met in September in Rockville, Md.
The primary objective of the PEC’s meeting was to discuss an FDA Ambassador program, which emerged from the group’s March 2019 meeting as a potential avenue to help the patient community engage with the FDA. The PEC discussed potential audiences for the program, as well...