Cancer patients’ quality of life is becoming an increasingly important outcome in clinical trials. Known as patient-reported outcomes (PROs), factors such as symptoms, function, and other health-related quality-of-life aspects, provide essential information about measuring the clinical benefit of any given therapy. There is however no consensus on the optimal methods to analyse PROs in cancer clinical trials.
A policy review paper, published in the February 2020 edition of The Lancet Oncology, has for the first time established International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials. A diverse panel of researchers and statisticians, key individuals from various international oncologic and medical societies, advisory and regulatory bodies, academic societies, pharmaceutical industry, cancer institutes and patient advocacy organizations formed the SISAQOL Consortium (Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints Data) and this review paper is the culmination of three years’ work on the topic. (the full, pre-release The SISAQOL consortium is led by the European Organisation for Research and Treatment of Cancer (EORTC). The full pre-print SISAQOL article can be downloaded via the EORTC website for free here.
The project lead, Dr Andrew Bottomley of the EORTC’s Quality of Life Department said: “The SISAQOL consortium includes all the major players in cancer QoL…For the first time it has been possible to get all these people together and achieve agreement on the best practices and standards and we are delighted that we have done it.”
The SISAQOL published recommendations aim to set standards that are technically correct, comprehensive and balanced, and can be applied to a broad range of cancer randomised clinical trials. The Lancet Oncology Policy Review paper was developed through critical literature reviews and a structured process.
IBTA Chair and Co-Director Kathy Oliver, who is one of the co-authors of The Lancet paper, said: “SISAQOL’s work highlights the vital importance of including PROs in all cancer research studies and will also help ensure that the issues which really matter to patients, and significantly impact them, are part of treatment decision-making in a much more consistent and accurate manner.”
A new online webtool which can be used in conjunction with the findings of the SISAQOL consortium is available here: https://event.eortc.org/sisaqol/interactive-webtool/