Between 2004 and 2012, the Number of Endpoints per Protocol has Nearly Doubled
Applied Clinical Trials
Tufts CSDD
The 10-year increase in the number of unique and total procedures per protocol corresponds to an increase in the number of endpoints supported by these procedures. Research conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) finds that between 2004 and 2012, the number of endpoints per protocol has nearly doubled from an average of eight per protocol in the earlier period to 14 endpoints in the later period. Half of all procedures support supplemental secondary, tertiary, and exploratory endpoints—a proportion that has remained constant during this eight-year period. Sponsor companies have added more procedures for a variety of reasons: clinical scientists seek more contextual data to interpret and validate findings and guide development decisions; statisticians wish to collect more data to explain observations and potential new interactions; and sponsor companies also note that procedures supporting tertiary and exploratory endpoints are added in anticipation of perceived or real regulatory agency and payor inquiry, commercialization, and competitive pressures.
—Tufts Center for the Study of Drug Development, https://csdd.tufts.edu.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
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.
