Principal Investigators Take the Lead FDA-Regulated Studies
Tufts CSDD
The total number of active principal investigators (PIs) participating in FDA-regulated studies worldwide has reached a record high of 27,924 due to rising clinical trial volume and more individual sites conducting fewer trials each year. More than half (53%) of all FDA-regulated clinical trials are now conducted by independent, community based PIs—the first time this segment has taken the leading proportion globally. University, hospital, and government clinics have been gradually losing their market share—falling from about two-thirds of all global FDA-regulated investigators in 2006 to less than half (47%) of the total in 2012.
Figure 1. The percentage of community-based investigators is growing worldwide.
—Tufts Center for the Study of Drug Development, https://csdd.tufts.edu.
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.
