First-in-Class vs. Later Entrants Approval Analysis
Nearly all later entrants to drug classes had begun clinical testing or were in regulatory review in the United States before the first drug within a pharmacologic class was approved, a newly completed analysis from the Tufts Center for the Study of Drug Development suggests.
The analysis looked at 40 pharmacologic classes and included drugs and biologics between the 2005 - 2011 period, where 90% of all later-in-class drugs had at least initiated Phase I clinical testing anywhere in the world or had filed an investigational new drug application with the U.S. Food and Drug Administration (FDA) before FDA approval for the first-in-class drug, according to Tufts CSDD.
Key findings from the studies, reported in the November/December Tufts CSDD Impact Report, included the following:
- 83% of all later-in-class drugs had at least initiated Phase II clinical testing abroad or in the U.S. prior to U.S. marketing approval for the first-in-class drug.
- All later-in-class drugs had a patent filed somewhere in the world before the first-in-class drug was approved in the United States; 96% had a U.S. patent filed before first-in-class approval.
- More than half of all later-in-class drugs received a 'priority rating' from the FDA.
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.
