The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership to identify practices that will increase the quality and efficiency of clinical trials founded by the FDA and Duke University. Recently, at the 48th Annual DIA Meeting, serveral CTTI projects were presented. These included Cynthia Hahn, Research Compliance Officer, Feinstein Institute for Medical Research, presentation, “Use of Central IRBs for Multicenter Clinical Trials” and addressed solicitation of current perceptions of barriers, development of a strategy to address identified barriers, and assessment reactions to proposed solutions to remove barriers.
The “Site Metrics for Study Start Up” project was delivered by Adam Chasse, MHA, Vice President, RxTrials, who explained the data collection, collaboration, and processes of the project.
CTTI posted slideshows and a video on the IRB project.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.