SISAQOL-IMI: generating new international standards for the use of patient reported outcome (PRO) data in cancer clinical trials Jayne Galinsky on behalf of Myeloma Patients Europe (MPE) and WECAN (Workgroup of European Cancer Patient Advocacy Networks)
SISAQOL IMI Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints
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n international multidisciplinary consortium, guided by the European Organisation for Research and Treatment of Cancer (EORTC), has been set up to generate recommendations to standardize the use, analysis, and interpretation of PRO data in cancer clinical trials . The consortium project - partly funded by the European Commission and partly funded by industry partners who, together make up the Innovative Medicines Initiative or “IMI” - is called SISAQOL-IMI . SISAQOL is the acronym for “Setting International Standards of Patient Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials” . The International Brain Tumour Alliance (IBTA) has been involved for a number of years in the first phase of the SISAQOL project and continues to be involved during this exciting new phase of SISAQOL-IMI . IBTA Chair Kathy Oliver serves on the SISAQOL-IMI project coordination team . Kathy said: “The SISAQOL-IMI initiative is a ground-breaking project which will set much-needed international standards for PRO analysis in cancer clinical trials, including those for brain and CNS tumours . It’s a very exciting initiative which the cancer patient community should welcome as a significant step forward in improving patient reported outcomes data collection and analysis .”
What are PROs? A PRO (patient reported outcome) is 108
Brain Tumour
Jayne Galinsky
information which is directly reported by the patient without the patient’s response being interpreted by a healthcare professional or anyone else . Generally, a patient reported outcome can reflect a patient’s health and/or functional status and quality of life . PROs are usually reported in response to a treatment regimen to determine how that treatment is affecting a patient, according to that patient’s own personal experience of it . PRO “tools” are questionnaires used within clinical trials to gather PRO data . The data collected from PROs help decision makers, such as those at the
European Medicines Agency (EMA) and US Food and Drug Administration (FDA), understand more about the benefits and risks of new medicines . Clinical trials in cancer are run by universities, pharmaceutical companies, and other organisations . Therefore, different people have different ways of collecting and analysing PRO data . This makes it difficult for decision makers to compare the results of cancer trials easily, consistently and fairly . The SISAQOL-IMI project was established to address these challenges . Researchers working on SISAQOL-IMI will agree on and publish a set of guidelines on how PRO data should be collected from patients, how it should be analysed, and how it should be presented to people who make important clinical and regulatory decisions in healthcare . The SISAQOL-IMI consortium is a group of leading researchers and statisticians, individuals from various international cancer and medical societies, advisory and regulatory bodies, universities, the pharmaceutical industry, cancer institutes and - crucially - patient advocacy organizations (represented by the Workgroup for European Cancer Patient Advocacy Networks, WECAN, and led by Myeloma Patients Europe, MPE, one of the WECAN members) . Overall, there are 41 stakeholder groups involved in the SISAQOL-IMI project .