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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Engaging patients at every stage of clinical research is no longer a “should,” it is a “must”. And, from quick online tools to in-depth financial reports, there are resources that can help you embed patient engagement in your research.
The Clinical Trials Transformation Initiative (CTTI) will host a webinar on Thurs., Feb. 27, at noon ET focusing on actionable resources for identifying patient engagement activities that bring high value – financial and...
CTTI has released a new preprint paper detailing its findings from a project designed to assess challenges and burdens associated with Good Clinical Practice (GCP) training.
The paper, “ More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant ,” outlines feedback on GCP training gleaned from interviews CTTI conducted with clinical investigators and research sponsors. While interview respondents recognized that GCP training addresses critical tasks necessary for the...
A recording is now available of a CTTI webinar held on Thurs., Jan. 16, which provided a recap of resources available to help implement a sIRB model, as well as an overview of a recent project CTTI undertook to develop a framework that could help in evaluation of the NIH’s single IRB (sIRB) policy. The webinar was led by Cynthia Hahn (Integrated Research Strategy), Stephen Rosenfeld (Secretary’s Advisory Committee on Human Research Protections), and Heather Pierce (Association of American Medical Colleges)....
Despite a growing enthusiasm for the use of master protocol studies, expertise is critically limited and few resources exist to guide planning and implementation. Working to fill this gap, CTTI held its first Master Protocol Studies expert meeting on Oct. 22-23 to identify strategies, tools, and resources that will help drive appropriate and efficient use of master protocols.
Attendees discussed challenges and...
A peer-reviewed article highlighting CTTI recommendations for improving investigator qualification was published this month in Contemporary Clinical Trials . This article details how to implement a more efficient and effective way to identify and prepare investigators and their delegates for the conduct of quality clinical trials, and how to determine whether a site team is a good fit for a particular protocol.
The paper urges...