The Cost to Develop an Approved New Drug Now Exceeds $2.5B
Based on a recently completed analysis, the Tufts Center for the Study of Drug Development (Tufts CSDD) estimates that the cost to develop a new prescription medicine that gains marketing approval is now $2.6 billion. This figure includes $1.4 billion in direct out-of-pocket costs to develop the new prescription drug, plus the high cost of drug failures and the capitalized costs spent over a lengthy drug development cycle time.
The estimated cost to develop an approved drug in 2003 is $1.04 billion (expressed in 2013 dollars). The updated $2.6 billion cost estimate represents an 8.5% compound annual growth rate over the 2003 level. Factors that have likely contributed to this high and rising cost to develop an approved drug include larger and more complex clinical trials and declining drug development success rates.
The Price of Innovation
- Tufts CSDD
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.
