Evidence Generation Throughout the Product Life-Cycle (D1.04)

Work package 1 has focused on evidence generation (in a MAPPs context) throughout the product life-cycle. Earlier work has reviewed IMI and non-IMI projects that might further support different stakeholders in developing and/or implementing the MAPPs approach. This review resulted in a distinction of ‘gaps’ as either being horizontal along the pathway or vertical in terms of gaps in the availability, depth of or quality of the tools and methods required to support the MAPPs approach. The initial gap analysis was presented to a multi-stakeholder workshop in January 2017 to identify consensus on the gaps identified and to find consensus on the priority topics that required more detailed research recommendations. These topics were identified as being:

  1. payer requirements
  2. single-arm studies
  3. indirect comparisons and observational data

Topic leads with expertise on these topics were found within the Consortium who developed draft research recommendations. The draft recommendations were subsequently shared with the Consortium partners for review and input. This document reports the final recommendations for further research on these topics that will enable the further development and implementation of the MAPPs approach in the European setting.