Organizations often engage Tufts CSDD to perform recurrent research assessments including:
Evaluating organizational practices and performance relative to comparable drug development benchmarks
Quantifying return on investment (ROI) and expected net present value (ENPV) of new practices and solutions
Listening sessions among clinical research professionals
Evaluating Practices and Performance Relative to Drug Development Benchmarks
Tufts CSDD has a rich history conducting benchmark assessments for drug development organizations in the public and private sector. Our studies are based on proprietary data capturing organizational practices, performance, economics, and other critical outcome variables. Tufts CSDD regularly updates its proprietary datasets and is always adding new baselines and benchmarks based on de-identified data from recently completed grant-funded research studies. Comparison groups in Tufts CSDD benchmark assessments are customized for each study. The results of our benchmark studies are used to diagnose performance, cost, and quality issues and inform strategy, productivity, efficiency, and scientific and operational optimization.
Tufts CSDD faculty also provides subject matter expertise and prepares expert reports based on benchmark data to inform the resolution of disputes.
Examples of recent benchmark studies include:
Evaluating protocol design practices in specific disease conditions
Comparing portfolio program cycle times, costs, and success rates
Assessing data management startup through close-out cycle times
Benchmarking patient recruitment and retention rates in select therapeutic areas
Comparing NIH clinical trial cycle times and costs to those in the private sector
Tufts CSDD has extensive experience conducting return on investment (ROI) assessments based on proprietary performance, economic, and quality benchmark data as well as primary and secondary data sources.
During the past decade, Tufts CSDD has also been modeling and quantifying the net financial impact of new practices and solutions applied to an investigational drug in comparison to a conventional drug. For these expected net present value (ENPV) studies, Tufts CSDD populates and tests each model using proprietary data on development timelines, costs, and risks. Data from primary and secondary sources are also gathered to populate the model. Tufts CSDD prepares the value drivers — including the investigational drug’s revenue potential; direct and indirect development costs; development and regulatory phase durations; scientific risk; regulatory risks; and operating risks — for a baseline drug in a major disease condition (e.g., oncology, CNS or infectious diseases). Next, Tufts CSDD will use qualitative and empirical data to derive adjustment factors and investment estimates.
ENPV modeling is widely used and accepted by the pharmaceutical industry. Tufts CSDD utilizes a framework where net present value is defined as the after-tax, inflation-adjusted present value of the future net cash flow for a drug that is granted regulatory marketing approval and is launched for sale in the marketplace. Once the model has been populated with data, adjustment factors, and investment estimates, Tufts CSDD will assess multiple drug development outcomes with the revenue and costs multiplied by the likelihood of each outcome occurring. Tufts CSDD will analyze the data on an expected net present value basis reflecting the sum total of risk for each of the various outcomes and their associated impact on revenue and development cost.
As an independent academic research group, with deep and broad drug development knowledge, Tufts CSDD is uniquely positioned to assist organizations in planning and facilitating Listening Sessions and Professional Advisories. Our extensive connections with regulatory agencies, health and research professional communities, societies, associations, and industry executives ensure the best composition of listening session participants.
Tufts CSDD conducts Listening Sessions and Professional Advisories both virtually and on-site. The virtual format, in particular, is highly cost-effective, convenient, and ensures international representation. Listening Sessions and Professional Advisories typically solicit feedback on:
Prioritizing research objectives and endpoints
Protocol design feasibility
Expected study volunteer recruitment and retention challenges
Clinical trial technology solutions
Medical and scientific communications