TL; DR

NOVA's approach allows for the model to be progressively updated with new information collected in response to the current question and help to answer a consecutive one. Thus a sequential process is created, like a virtuous circle, which will guide the development and marketing of future new treatments.

In light of the previously provided contents (see Boxes 3, 4, 5, 6 and Figure 1), it becomes apparent that NOVA’s approach can help provide answers to questions concerning the whole lifecycle of a new therapy, with the absolute benefit (AB) and the number of prevented clinical events (NPE), the events that matter for patients, as outcome measures for the benefit of the individual and that of the population.

There are two advantages of using these measures: 1) successive decisions during development are taken with the same alder; 2) at any time, one or more comparators or future competitors can be introduced into the process, always with the same decision criteria.

Questions the NOVA approach can address with always always aiming to maximize the AB and the NPE are listed in Box 10. And more generally, at each stage, should you go on or not?

Box 10: Questions addressed by the NOVA approach during the R&D and translation to market

• The exploration of new therapeutic approaches
• The search for a target or a combination of targets
• The optimization of the mode of action, i.e. search for parameters of the drug-target interaction
• Prior to starting to shift to human clinical trials, what is the predicted dose-response- response-effect relationship?
• Once the PK is known; what is the refined dose-response relationship?
• What is the mechanism of action (i.e. the systems and systems entities and functions) involved in the efficacy?
• Should the drug be developed as a combination? With which other compound?
• Demonstration of surrogacy
• Responders
• The optimal regimen
• Interactions with the components of the standard of care
• The design of clinical trials such that the cost is minimal for a contribution of new information and with a maximum chance of success
• Virtual control arm(s): placebo, competitor(s)
• Reduction of uncertainties of real-life application
• Pricing
• Time

The model established to answer an initial question will be progressively updated with new information collected in response to the current question and help to answer a consecutive one. Thus a sequential process is created, like a virtuous circle (see Figure 1), which will guide the development and marketing of future new treatments.