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

The patient-reported outcome content of international ovarian cancer randomised controlled trial protocols

“…Ultimately, PRO design decisions impact what treatments are approved for use and offered to patients, therefore the methodology must be carefully justified in the protocol. Regulatory bodies, such as the Food and Drug Administration (FDA) and European Medical Association (EMA) recognise the value and importance of high-quality PRO assessment in the therapeutic approval process, and accordingly offer PRO assessment guidance [12][13][14]. Likewise, the Cochrane handbook offers clear guidelines for assessing the PRO evidence of intervention research in the context of conducting a systematic review [15].…”

Relationship between subjective and actigraphy-measured sleep in 237 patients with metastatic colorectal cancer

“…Indeed, patient-reported outcomes are being increasingly recognized as valid and reliable measurements, with important clinical relevance. [39; 40] This recognition given to patient-reported outcomes seems particularly appropriate for sleep quality, a common, bothersome, yet overlooked problem in cancer patients. [13] Similarly, circadian function is rarely evaluated in cancer patients, despite its clinical impact.…”

Investigating the impact of open label design on patient‐reported outcome results in prostate cancer randomized controlled trials

“…[8][9][10][11] Both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) highly endorse the use of patient-reported outcomes (PROs) in this context by requiring the integration of the patients' perspective through better reporting of adverse events and HRQoL in randomized controlled trials (RCTs). 12,13 However, several systematic reviews have highlighted that a high proportion of RCTs including PROs poorly report on these measurements, with missing information being very common. [14][15][16] Another important methodological issue with the reporting of PROs in RCTs is the open-label setting.…”

“…The latter is therefore also an important factor when treatment choices have to be made 8‐11 . Both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) highly endorse the use of patient‐reported outcomes (PROs) in this context by requiring the integration of the patients’ perspective through better reporting of adverse events and HRQoL in randomized controlled trials (RCTs) 12,13 …”