Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man

The use of patient-reported outcome (PRO) measures in oncology studies

We have adopted this International Scientific Guideline - EMA/CHMP/292464/2014.

Last updated

3 June 2024

About this guideline

Adopted by the TGA: 11 November 2022

Overseas effective date: 1 November 2016

Categories: Clinical efficacy and safety | Antineoplastic and immunomodulating agents

TGA annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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