In Part 1 of this series, we discussed Integrated Evidence Plans (IEPs) whose purpose is to identify and prioritize evidence gaps aligned with commercial goals to obtain regulatory approval in markets of interest, optimize access, and achieve a price that reflects the holistic value of a given asset. We noted that the creation of a formal IEP was essential to new product development and that it requires keen attention to planning and coordination across many internal functions to ensure efficiency and success. However, to deliver and execute IEPs that allow companies to realize the full holistic value of their products, several historical flaws or pitfalls of IEPs need to be addressed. The first of these pitfalls that we discussed focused on the timing of evidence development, the inclusion of all appropriate stakeholders, and the appropriate application of lower hierarchical study designs such as RWD, PRO and QoL, and need for budget and evidence prioritization.

Other potential IEP pitfalls that need to be addressed include: