1976
Tufts CSDD identifies “drug lag” - delayed drug availability in the US compared to the U.K.
1979
Tufts CSDD conducts the first comprehensive study of the cost to develop a new drug: $54 million.
1981
Research demonstrates dramatic decline in effective patent life for new therapeutic compounds.
1982
Tufts CSDD completes the first analysis of availability of drugs for limited populations, paving the way for the Orphan Drug Act of 1983.
1984
Tufts CSDD deelops the first comparison of the rate of drug safety withdrawals in the U.S. and abroad.
1987
Tufts CSDD publishes the first comprehensive analysis of the FDA’s practice of requiring post-approval research as a condition of approval.
1991
Tufts CSDD updates its seminal drug cost study: it now costs $231 million to develop a new drug.
1993
Tufts CSDD develops the first international comparison of biotechnology product discovery, development & marketing rates in the U.S., Europe, and Japan.
1995
Tufts CSDD publishes the first comprehensive analysis of biotechnology success rates.
1996-97
Tufts CSDD provides data and public testimony at Congressional hearings that led to the passage of the FDA Modernization Act of 1997 (FDAMA).
1997
Tufts CSDD completes comprehensive analysis of FDA/sponsor meetings, showing that meetings reduce the time of new drug development.
1998
Tufts CSDD publishes analysis showing impact of the Prescription Drug User Fee Act of 1992 (PDUFA) on drug development times.
1999
Tufts CSDD provides first comprehensive analysis and review of FDAMA’s pediatric research incentive program.
2000
Tufts CSDD publishes comparative analysis of new drug and biopharmaceutical approval times under the Centralized Procedure of the European Medicines Evaluation Agency (EMEA) and the U.S. FDA.
2003
Tufts CSDD updates its ongoing analysis of average cost of pharmaceutical R&D. It now costs $802 million to develop a new drug and bring it to Market.
Tufts CSDD provides first assessment of the impact of the FDA’s new fast track program on total development times.
2004
Tufts CSDD completes analysis on the economics of follow-on drug development and incremental innovation.
2005
Tufts CSDD provides quantitative evidence demonstrating the lack of correlation between drug safety withdrawals and speed of regulatory approval.
2006
Tufts CSDD publishes the first comprehensive estimate of the average cost of developing a new biotechnology product at $1.2 billion.
Tufts CSDD publishes results of a new study documenting dramatic increase in outsourcing practice and characterizing use of individual outsourcing models.
2007
Tufts CSDD publishes extensive analyses on oncology drug R&D noting that the overall approval success rate is 8% & provides the first analysis documenting high turnover, volatility, and inexperience in the global investigative site landscape.
2008
Tufts CSDD publishes quantitative analysis demonstrating that U.S. drug plans, in covering 88% of drugs in six therapeutics areas are non- compliant with Medicare regulations.
2009
Tufts CSDD updates its ongoing analysis of new drug clinical success rates. Overall clinical success rates have fallen to 16%.
2010
Tufts CSDD documents integration of orphan drug development into company portfolios, representing 25% of all new approvals, and a doubling of designations in the past decade.
2011
Tufts CSDD provides first analysis documenting lack of clinically useful diagnostics and how it is hindering growth in personalized medicines;
Publishes first study on the incidence, cause, and impact of protocol amendments on clinical trial performance.
2012
Tufts CSDD provides the first analysis documenting the dramatic rise in protocol complexity.
2015
Tufts CSDD publishes the first comprehensive analysis of vaccine development trends.
2016
Tufts CSDD is the first to document the rapid growth of pharmaceutical benefit managers Exclusion Lists, and the challenges these pose to drug developers.
2017
Tufts CSDD is the first to demonstrate that drugs utilizing FDA’s 505(b)(2) regulatory pathway, which is supposed to speed up the review process, take five months longer to approve than new molecular entity approvals.
Tufts CSDD publishes the first study measuring the scope and impact of data volume and data diversity supporting clinical trials.
Tufts CSDD provides the first analysis of the expected net present value of patient engagement practices supporting oncology development programs.
2018
Tufts CSDD publishes studies documenting the adoption of, and challenges associated with, real world evidence, real world data, and artificial intelligence.
2019
Tufts CSDD provides the first analysis of the volume and cost of vendor qualifications and re-qualification assessments.
2020
Tufts CSDD publishes the first study quantifying participant demographic diversity in pivotal trials of FDA approved drugs and biologics.
2021
Tufts CSDD conducts the first empirical study on the diversity of global site personnel and finds a strong positive correlation between the race and ethnicity of study staff and patients enrolled.
Tufts CSDD derives cycle time benchmarks on the stages of adopting innovations supporting clinical operations.
2022
The Center applies expected net present value (ENPV) modeling to quantify the net financial impact of using decentralized clinical trial solutions (DCTs) to support clinical trial execution.
2024
CSDD quantifies the net financial impact of deploying digital endpoints in clinical trials.
The Center provides new evidence demonstrating the declining value of a day of delay in prescription drug and biologic sales.
2025