The European Organisation for Research and Treatment of Cancer (EORTC) is pleased to announce a new collaboration with CDISC, a leading provider of data standards in clinical research.
With its Quality of Life measures, EORTC provides the wide research community with questionnaires through which health-related quality of life of cancer patients and survivors can be assessed and their experience put at the forefront.
CDISC develops and advances data standards enabling interoperability and reusability of data. CDISC standards are required for submissions to regulatory agencies including the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
Through this partnership, the EORTC Quality of Life measures will be migrated into CDISC standards, facilitating their use in future clinical trials and in the context of data submission to regulatory authorities. The development of CDISC packages for the EORTC Quality of Life questionnaires has already started with the EORTC QLQ-C30, with the Controlled Terminology and annotated Case Report Forms being available, and will be progressively developed for further, most commonly used EORTC Quality of Life measures.
In a world of high regulatory requirements, enabling the integration of the EORTC Quality of Life measures into the internationally-recognised CDISC standards means more standardisation of data collection. It will allow users of the EORTC questionnaires to gather and analyse their data more reliably and consistently, as well as facilitate regulatory submissions.