Applied Clinical Trials
A recent study conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) found that more than half of all protocols require one or more amendments.
A recent study conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) found that more than half of all protocols require one or more amendments. Based on data from 3,410 protocols provided by 17 large and midsize pharmaceutical and biotechnology companies, Tufts CSDD found that completed protocols across all phases had an average of 2.5 amendments requiring 6.9 changes to the protocol per amendment. Later-stage Phase II and III protocols had a higher average number of amendments, 2.7 and 3.5 respectively. The most commonly cited causes of amendments included the availability of new safety information, requests from regulatory agencies to amend the study, and changes in the study strategy. Protocol design flaws and difficulties recruiting study volunteers were also cited as top causes. The study found that the incidence of amendments is associated with protocol complexity and duration. The mean number of amendments per protocol, for example, was positively and significantly correlated (p<.001) with the number of procedures per protocol, study length, and the number of investigative sites conducting that protocol.
—Tufts Center for the Study of Drug Development, http://csdd.tufts.edu.
Mean number of amendments per protocol. (Source: Tufts Center for the Study of Drug Development)
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
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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.