Joint European Medicines Agency (EMA) / European Organisation for Research and Treatment of Cancer (EORTC) workshop on novel patient-reported outcomes (PRO) and quality of life (QoL) approaches in cancer clinical research
Update: Due to a number of cancellations of participants, this workshop is postponed to later in 2020. EMA will contact registered participants as soon as the new date is available.
The objectives of this joint workshop are to discuss novel approaches to define and use instruments and tools for patient-reported outcomes (PRO) and quality of life (QoL) information that can be used in cancer clinical research, cancer medicine development and clinical cancer care.
The European Organisation for Research and Treatment of Cancer (EORTC) has developed an item library from which researchers and clinicians can select parts of existing, validated instruments that best fit a trial’s research questions and can add provisions to capture symptoms and adverse events not covered by existing instruments. Furthermore, international consortia have published recommendations concerning patient-reported outcomes, covering selection of measures, writing protocols, presenting and interpreting results.
During the workshop, academia, regulatory agencies, health technology assessment bodies and patient organisations will present experience and views. The focus of the discussions will be how PRO and QoL instruments can become an integral part of a more patient-centred drug development of treatments for cancer patients.