Questions Optimizing Calculator
This free tool enables you to calculate risk-adjusted project values, prioritize scientific questions, and identify the best path for product development. It is a component of the online course Clinical Product Development, where you will also learn to determine a safe and informative starting dose for First-in-Human trials using the NOAEL and MABEL methods. The course includes assignments based on real-world case studies, ensuring an engaging and practical learning experience.
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Why did we develop this tool?
Traditionally, the valuation of R&D projects in the life sciences sector is determined by calculating the Net Present Value (NPV) or the risk-adjusted Net Present Value (rNPV). These calculations primarily rely on assumptions about development timelines, costs, risks, and projections of future revenue.
However, NPV calculations often overlook scientific factors specific to the medical intervention and disease indication. In the online course Clinical Product Development, you will not only master the NPV and rNPV methods but also learn to evaluate project value using Real Option Analysis, guided by a set of critical questions.
Although these questions may seem straightforward, the projected risks and costs associated with each question significantly impact development decisions. Addressing these questions effectively during the development process ensures the highest possible risk-adjusted project value.
The Questions Optimizing Calculator serves as a simplified, practical tool to navigate this decision-making framework. It provides an optimal priority list of key questions, based on the estimated probability of successfully addressing each question and the effort required 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 Product Development
Clinical development is crucial part of R&D for new products. Enhance your skills in selecting safe and informative starting doses using NOAEL and MABEL methods, and gain insight in project valuation calculations through case studies based on real-world R&D projects.