Questions Optimizing Calculator
This tool helps to optimize the development of novel medical interventions such as medicinal products, medical devices and medical nutrition. Using risk-adjusted project values to rank key scientific questions, the tool identifies the optimal path for developing a new medical intervention. Watch the tutorial from Dr. Saco de Visser, developer of the tool and course teacher of the course Clinical Development. Create an account to use the tool for free.
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Why did we develop this tool?
This tool lies at the heart of the question-based approach to clinical development. It aims to answer the central question: “What are the key scientific questions and what is the estimated priority ranking to address them?”
Value calculations of R&D projects oftentimes depend on assumptions about development time, cost and future revenues. Scientific considerations specific to the medical intervention and the disease indication are rarely taken into account. The Question Based Clinical Development (QBCD) approach redefines the developmental pathway of new medical interventions based on a number of key questions. These questions may seem obvious, however, the projected risks and costs of each question influence the choices made during development. Optimally addressing these questions in the developmental process gives the highest risk-adjusted project value.
The Questions Optimizing Calculator is designed as a simplified and practical tool to guide you through this decision tree. The outcome is an optimal priority list of the key questions based on the estimated probability of successfully answering each question and the efforts needed to do so.
Why is this tool special?
The number of key questions this tool can analyze ranges from 1 to 6. Each key question has a probability of success (or success rate) and associated cost or efforts needed to answer the questions in clinical studies. Estimating success rates is not an exact science but is the result of group discussions, historical data or just an educated guess when such data is lacking.
The tool helps to prioritize the defined scientific questions based on how you allocate development risks. It will not alter the risks of developing a particular intervention but allows you to optimally deal with the intrinsic risk. One question can be addressed in several clinical studies, and one clinical study can provide a partial answer to several questions.
As a starting point, a generic list of key questions can be:
Does the intervention reach the site of action?
Does the intervention cause its intended functional effect?
Does the intervention have beneficial effects on the disease or its clinical pathophysiology?
What is the therapeutic window of the new intervention?
How does the variability in the target population’s response affect the development?
We encourage you to define your own key question that specifically apply to your intervention.
Part of the course Clinical Development
Project valuation in life sciences R&D is essential for assessing the financial viability and strategic value of developing new products. Learn the principles of various value calculation methods and how to apply it to real R&D projects.
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Your teacher
Marcel Kenter