International Society for Quality of Life Research commentary on the draft European Medicines Agency reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies.

Published

Journal Article

In 2014, the European Medicines Agency (EMA) released for comment a draft reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies. A twelve-member International Society for Quality of Life Research (ISOQOL) taskforce was convened to coordinate the ISOQOL response. Twenty-one ISOQOL members provided detailed comments and suggestions on the paper: 81 % from academia and 19 % from industry. Taskforce members consolidated and further refined these comments and shared the recommendations with the wider ISOQOL membership. A final response was submitted to the EMA in November 2014. The impending publication of the EMA reflection paper presents a valuable opportunity for ISOQOL to comment on the current direction of EMA PRO guidance and strategy. The EMA paper, although focused on cancer, could serve as a model for using PROs in other conditions, as it provides a useful update surrounding some of the design issues common to all trial research including PRO endpoints. However, we believe there are a number of additional areas in need of greater consideration. The purpose of this commentary is therefore to highlight the strengths of this timely and potentially useful document, but also to outline areas that may warrant further discussion.

Full Text

Duke Authors

Cited Authors

  • Kyte, D; Reeve, BB; Efficace, F; Haywood, K; Mercieca-Bebber, R; King, MT; Norquist, JM; Lenderking, WR; Snyder, C; Ring, L; Velikova, G; Calvert, M

Published Date

  • February 2016

Published In

Volume / Issue

  • 25 / 2

Start / End Page

  • 359 - 362

PubMed ID

  • 26275979

Pubmed Central ID

  • 26275979

Electronic International Standard Serial Number (EISSN)

  • 1573-2649

Digital Object Identifier (DOI)

  • 10.1007/s11136-015-1099-z

Language

  • eng

Conference Location

  • Netherlands