Patient-reported outcomes in ovarian cancer clinical trials.

There is general acceptance of the importance of incorporating patient-reported outcome (PRO) measures including health-related quality of life (HRQOL) into clinical trials, and there are now a number of guidance documents available on how to use PRO's for regulatory authorities and in comparative effectiveness research. The methods used to collect, analyse and report PRO data in clinical trials have received considerable scrutiny, revealing many shortcomings in the standard of reporting of HRQOL in clinical trials as well as in how PRO's have been selected and analysed in clinical trials. This has led to the recent Consolidated Standards of Reporting Clinical Trials-PRO extension statement which lays down a framework for selection and reporting analysis of PROs, either as primary or secondary trial end points, thus ensuring scientific rigour. Adherence to these guidelines can only improve the conduct of clinical trials and interpretation of their results, which may help avoid missing out on opportunities as in the past. We review pertinent literature on PRO measures and discuss how various recent PRO guidance documents should be applied to ovarian cancer clinical trials.