EMA-EORTC workshop emphasises the important role of patient-reported outcomes (PROs) in the assessment of cancer drugs

Patient-reported outcomes (PROs) such as symptoms or health-related quality of life are important criteria for the assessment of cancer drugs. To be used meaningfully, PROs must be planned, recorded, analysed and reported in an adequate manner, just like all other outcomes. “From an HTA perspective, the instruments used for the recording of PROs must permit a fair comparison between a new drug and the standard of care,“ says Beate Wieseler, Head of IQWiG's Drug Assessment Department. This also applies across different studies and over a longer period of time so that indirect comparisons between different treatment options are possible. It is also important for Health Technology Assessments (HTAs) that PROs are recorded long enough (and also beyond disease progression, for example) to allow an adequate assessment of a treatment option’s benefit. There are a number of initiatives to improve the methodological principles for the use of PROs, in particular SISAQoL (Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data), in which IQWiG is intensively involved.

From IQWiG's point of view, these are the key results of a joint workshop of the European Medicines Agency (EMA) and the European Organisation for Research and Treatment of Cancer (EORTC), in which specialist groups, patients, regulatory authorities, HTA organizations (including IQWiG) and industry took part. The results of the workshop have just been published in an article in The Lancet Oncology.