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.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.