Bridging the Gap Between RCTs and RWE Through Endpoint Selection

Ther Innov Regul Sci. 2021 Jan;55(1):90-96. doi: 10.1007/s43441-020-00193-5. Epub 2020 Jul 6.

Abstract

This commentary is authored by several industry real-world evidence (RWE) experts, with support from IQVIA, as part of the 'RWE Leadership Forum': a group of Industry Leaders who have come together as non-competitive partners to understand and respond to RWD/E challenges and opportunities with a single expert voice. Here, the forum discusses the value in bridging the industry disconnect between RTCs and RWE, with a view to promoting the use of RWE in the RCT environment. RCT endpoints are explored along several axes including their clinical relevance and their measure of direct patient benefit, and then compared with their real-world counterparts to identify suitable paths, or gaps, for assimilating RWE endpoints into the RCT environment.

MeSH terms

  • Humans
  • Randomized Controlled Trials as Topic*