OHE Research Paper 18/02: Real World Evidence (RWE) – This paper provides a framework and specific steps to help both manufacturers and payers meet the challenge of developing observational RWE through a transparent process that can be considered credible by all stakeholders.

OHE Research Paper 18/02: Real World Evidence (RWE) – This paper provides a framework and specific steps to help both manufacturers and payers meet the challenge of developing observational RWE through a transparent process that can be considered credible by all stakeholders.
 
It presents a new conceptual framework to address three elements largely missing from these earlier efforts focused on defining “best practices” or “standards” for RWE. These are: 1) how to understand the role that contextual factors play in determining how high the evidentiary standard, or “bar” will be in each situation; 2) how to tailor key process and methodological approaches the height of that evidentiary bar; and 3) how to ensure that broader process principles that support transparency are integrated successfully throughout the course of any RWE initiative. 
 
This paper is a companion piece to a detailed background paper on the use of RWE in coverage decisions developed for the Institute for Clinical and Economic Review (ICER) Policy Summit held in December 2017.