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.
The European Organisation for Research and Treatment of Cancer (EORTC) is a non-governmental, non-profit organisation, which unites clinical cancer research experts, throughout Europe, to define better treatments for cancer patients to prolong survival and improve quality of life. Spanning from translational to large, prospective, multi-centre, phase III clinical trials that evaluate new therapies and treatment strategies as well as patient quality of life, its activities are coordinated from EORTC Headquarters, a unique international clinical research infrastructure, based in Brussels, Belgium.
For further information, please visit the EORTC website: eortc.org
About the Quality of Life Group
The Quality of Life Group (QLG) strives to improve health-related quality of life (HRQoL) of cancer patients, through dedicated research and the use of HRQoL measures within cancer clinical trials and clinical practice. HRQoL constitutes an important aspect of cancer research and care: it gives a voice to patients, putting their experience at the forefront. The QLG is part of the European Organisation for Research and Treatment of Cancer (EORTC).
For further information, please visit the QLG website: qol.eortc.org
Clinical Data Interchange Standards Consortium (CDISC) is a global non-profit organization that develops and advances data standards of the highest quality to transform incompatible formats, inconsistent methodologies, and diverse perspectives into a robust framework for generating accessible clinical research data. Driven by the belief that the true measure of data is its impact, CDISC convenes a global community of research experts representing a range of experiences and backgrounds to harness the collective power to drive more meaningful clinical research.
Caroline Hance (EORTC QLG)