Celebrating 50 Years of Impact

Since 1976, the Tufts Center for the Study of Drug Development (Tufts CSDD) at the Tufts University School of Medicine has been a leading voice and an essential independent, scholarly source for timely, relevant, objective and impactful data, benchmarks and insights.  Now celebrating its 50^th anniversary, Tufts CSDD research informs and influences professional and public understanding of the global drug development enterprise.

Each year Tufts CSDD conducts 12-15 empirical research studies; publishes its findings in peer-review and trade journals; convenes global roundtable meetings and facilitates industry consortia; presents research highlights at conferences and corporate gatherings; produces annual and custom professional development programs; and participates in general and special sessions with regulatory and government officials.

Our research focus over five decades has expanded to meet the evolving needs of drug development stakeholders. In the late 1970s, we focused on US regulation and its impact on therapeutic innovation. In the 1980s we were the first to begin assessing the economics and success rates of new drugs and biologics. The 1990s and early 2000s introduced hard-hitting analyses of global clinical and review durations and the impact of macro-level pre- and post-approval trends.  Between the late 2000s and the mid-2020s,  Tufts CSDD began evaluating and benchmarking the impact of protocol design practices, operating practices and technology solutions, collaborative relationship management and organizational behaviors, mechanisms and structures. 

In addition to developing and running custom global educational programs, during the past 50 years Tufts CSDD has organized and produced the Post Graduate Course on Clinical Pharmacology, Drug Development and Regulation.   Thousands of global professionals from government agencies, industry, foundations, non-profit agencies, service providers have taken this widely-recognized course and received their certificate of completion.  

It has been our sincere privilege to serve the drug development enterprise and we are proud of our 50 years of impact. 

Anniversary Wishes and Reflections

2026 Schedule of Events 

Tufts CSDD research over the past five decades has been timely, relevant and instrumental in informing global drug development strategies, policies and practices. Examples of our seminal research studies include:

• A 1976 study identified delays in the availability of drugs approved for US patients
• A 1984 study looked at drug safety withdrawals the availability of drugs approved for rare diseases influencing the Orphan Drug Act
• A 1991 study — now updated periodically —was the first to quantify the capitalized cost to develop a single successful drug
• A 1997 presentation of Tufts CSDD research at congressional hearings influenced the passage of the FDA Modernization Act
• A 2000 study compared global regulatory review and approval durations
• A 2008 seminal study —now updated every five years — benchmarked the complexity of protocol designs and their impact on clinical trial performance
• A 2011 study – now updated every five years — assessed the incidence, causes, impact and cost of protocol amendments
• A 2017 roundtable among global industry and regulatory professionals — the first of many produced and facilitated by Tufts CSDD every three years —have informed ICH E6 R2 and R3 final guidelines
• A 2020 study established robust baseline measures quantifying disparities in the demographic representation of participants — based on disease prevalence — in pivotal trials of approved drugs and biologics
• A 2025 study detailed use cases and the impact of machine learning and artificial intelligence/generative and agenetic AI applications on drug development performance

The New Yorker Magazine, 1979