Identification of assessment criteria used at decision points throughout the medical product lifecycle

The pharmaceutical industry, regulatory authorities, and health technology assessment (HTA) bodies in general agree that the use of patient preference information might benefit decision-making throughout the medical product lifecycle (MPLC). However, to date there is no clear overview which integrates the critical decision points along the MPLC for the different stakeholders involved. It is also unclear how and based on what information and criteria, these stakeholders make their decisions. If the role of patient preference information (PPI) in decision-making should increase, a clear overview of where such information is most useful is crucial. This task aims to characterize (1) the decision points throughout the MPLC, (2) the activities that are carried out during these decision points, (3) the types of assessments made at these points, (4) the assessment criteria used to make decisions at these points separately for the pharmaceutical industry, regulatory authorities and HTA bodies and (5) at which decision points there is a potential role to include PPI.