White paper on current barriers to the acceptability of pragmatic trial data in decision making

Task 1.2.2 Identification of barriers to the use of PCT data in decision making and prioritisation of efforts (M2-M8) (UMCU, Lilly, Bayer, LA-SER, GSK, AZ, UCB) The acceptability of pragmatic trial data in decision making will be assessed, critical barriers will be identified and an action plan will be defined to address those barriers identified as priority. It is envisaged that the Task Force will identify a number of pragmatic trials that have concluded recently and have been discussed directly with regulators and payers. In collaboration with the Think tank insights will also be gained through direct interaction with EUnetHTA, HTAs and regulatory bodies, using PragMagic as a tool to facilitate discussion and understanding about these barriers and possibilities to overcome them. The outcomes of the assessment and the possible guidance received by decision-makers will be captured in a white paper (D1.7) and fed into the development of the PragMagic Tool (Tasks 1.2.3-1.2.6) and the statistical approaches (Tasks 1.2.7-1.2.8).