1. Reflection Paper on the use of patient reported outcome (PRO) measures in oncology studies. EMA/CHMP/292464/2014.
2. 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. EMA/CHMP/292464/2014.
3. Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. FDA, December 2009.
4. Friends of Cancer Research. Broadening the definition of tolerability in cancer clinical trials to better measure the patient experience. Available at: https://friendsofcancerresearch.org/wp-content/uploads/Comparative-Tolerability-Whitepaper_FINAL.pdf.
5. De Muro C, Clark M, Doward L, Evans E, Mordin M, Gnanasakthy A. Assessment of PRO label claims granted by the FDA as compared to the EMA (2006–2010). Value Health. 2013;16(8):1150–5.