The number of countries used in commercially sponsored Phase III clinical trials has not changed in recent years.
Are pharmaceutical company Phase III clinical trials becoming more complex? The most broadly based database available, ClinicalTrials.gov, does not support the assertion that clinical trials have become more complex in study/protocol design or execution. Illustrative is the number of countries used in pharmaceutical company sponsored Phase III clinical trials.
The number of countries used in commercially sponsored Phase III clinical trials has not changed in recent years. It is essential to stratify the results or otherwise the data appear to show that the number of countries per study has actually declined, so we stratified the studies by planned study duration: less than one year, 1 to 2 years and 3 or more years. This is important because the longer the planned study, the more likely the study may be opening sites in additional countries. When stratified this way, the data show practically no change over the years covered.
Average Number of Countries per Study by Designed Study Duration by Year
Source: Department of Health Policy and Public Policy, University of the Sciences, Philadelphia, PA, using ClinicalTrials.gov data.
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.