OBJECTIVES: The US Food and Drug Administration (FDA) published guidance (2006, 2009) on the use of patient-reported outcome measures (PROMs) in labelling claims places an emphasis on areas such as psychometric validation and interpretability of PROMs, in addition to statistical issues. Given that the vast majority of oncology PROMs were developed prior to the guidance it is appropriate to re-evaluate these PROMs to determine whether they comply with the new regulatory advice. METHODS: A comprehensive meta-review was undertaken of systematic reviews of oncology patient-reported outcome measures (PROMs) used in randomised controlled trials (RCTs). The Cochrane Library, PubMed, Ovid, PsychInfo and EMBASE databases were searched. English language articles published between 2000 and 2011 were identified. RESULTS: A final 7 systematic reviews were identified from 435 potential articles involving 443 RCTs in oncology. The reviews covered lung, breast and colorectal and advanced cancers, leukaemia and multiple myeloma. A total of 71,379 patients had completed the PROMs in the RCTs. The most commonly used instruments were the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (38% of RCTs) and the Functional Assessment of Cancer Therapy – General (FACT-G) questionnaire (18% RCTs). A total of 82% RCTs had used psychometrically validated instruments; 70% trials reported culturally valid instruments and virtually all RCTs reported timing of PROMs assessment (97%). However, only 28% RCTS reported clinical significance, 32% reported missing data and 25% provided a priori hypothesis of expected changes in PROMs scores. CONCLUSIONS: Although oncology PROMs currently utilised in RCTs are compliant with certain areas of the FDA guidance, there are critical aspects where these fall short of the requirements, particularly in terms of missing data and clinical interpretation. These methodological limitations will need to be addressed if oncology PROMs are to be used to successfully support labelling claims.