A Different Look at Protocol Procedure Complexity
A substantial increase in procedure complexity should be reflected in increasing per patient costs of Phase III clinical trials,which is not true from this data.
Procedure complexity is frequently defined as the number of unique procedures and/or the amount of activity associated with a given procedure. But a substantial increase in procedure complexity should be reflected in increasing per patient costs of Phase III clinical trials, unless sites around the world have decided to perform a rapidly growing number of medical procedures at no additional cost to the commercial companies sponsoring the studies. This is probably not a widespread practice.
According to this article, clinical grant costs are not increasing. But neither has the total average cost-per-patient. We should expect some variation from year to year simply because new studies will reflect a different distribution of therapeutic areas.
From two clinical grant benchmarking systems in use by sponsor companies and CROs, which use these databases to develop clinical grant cost figures in the United States. Organizations conducting nearly 80% of all Phase III clinical trials submit their clinical grant data to the IMS Health clinical grant database, GrantPlan, from which this data was gathered.
Source: University of the Sciences, Mayes College, using IMS Health 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.
