WP2 Use of surrogate outcomes for medical devices: advanced methodological issues

WP2 is led by the University of Exeter Medical School, and its overall aim is to improve the decision-making process concerning new or existing technologies, specifically medical devices, whose evidence base is mainly supported by surrogate outcomes.



Objectives:
  • To review and map current use of surrogate outcomes evidence in economic evaluations in HTA reports and recommendations in HTA methods guidelines;
  • To provide recommendations on the use of various sources of evidence (including randomised controlled trials (RCTs), observational studies, registries, surveys or routine administrative databases) and types of evidence (e.g. study vs individual participant level data) needed to validate putative surrogate outcomes;
  • To develop a framework for health care policy makers on surrogate outcomes-based value determinations for medical devices (and other technologies) and to identify potential levers and barriers to its implementation.


Outcomes:
  • A report will be produced to review and map current use of surrogate outcomes evidence in economic evaluations in HTA reports and recommendations in HTA methods guidelines
  • Case studies will be used to illustrate the range of surrogate validation processes and methods used within HTA economic evaluations. Different surrogate validation techniques will be tested and assessed with respect to their potential to inform the HTA decision-making process concerning health technologies.
  • Development of a methodological framework and policy tool for the evaluation of medical devices and other health technologies that depends on surrogate outcomes evidence.