Strategic Evidence Generation Planning: Objectives, Requirements, and Processes
Drugs, medical devices, and other healthcare products and services are, for good reasons, different in nature if compared with “regular” consumer products. The main reason for this is that they might be associated not only with benefits but also with substantial health risks for patients using/taking them.
That is why the whole healthcare market – including different stakeholders such as regulatory bodies, patients, physicians, other healthcare professionals, hospitals, payors, Health Technology Assessment (HTA) Agencies, and others – works in a way that all main arguments in favor of a healthcare product/service and, specifically, all formal decisions regarding these products need to be supported by scientific evidence.
Scientific evidence needs might differ substantially between the different stakeholders, but they also vary between countries due to different philosophies in the assessment of healthcare interventions. This requires early Global Evidence Generation planning.
The results of that planning – down to the level of study planning – is the Evidence Generation Plan (EGP). This paper deals with the process of developing an EGP. Please note that market research, scientific communication, and general stakeholder management will not be included in this paper as they are typically not included in an EGP focusing on scientific evidence needs. Without any question, these activities are essential, but they are typically not part of an EGP.