The very first expert-based guidance for reporting real-world evidence studies specifically for oncology, “ESMO Guidance for Reporting Oncology real-World evidence (GROW)", has been developed by ESMO, together with the valuable contribution of external stakeholders.
ESMO-GROW provides guidance for full article development – including title, introduction, methods, results, discussion, conclusions – in the form of a comprehensive list of detailed key recommendations that incorporate several peculiarities of modern RWE research in oncology. This includes the rapid development of novel treatment strategies for subgroups of patients, recent trends for molecular-based epidemiology analyses, considerations on oncology-specific variables or outcomes, novel research designs and the increased use of artificial intelligence, machine learning and deep learning in this field.
Underlying the development of the ESMO-GROW guidance was the realisation that the use of real-world data (RWD) is growing rapidly to complement interventional clinical trial-based evidence, especially in oncology. “This project was initiated by a group of experts who agreed that there was an important unmet need to develop a modern and specific guidance to report oncology RWE studies,” points out lead author Dr. Luis Castelo-Branco. “Considering this a growing and rapidly evolving field, we expect ESMO-GROW to be widely used within the oncology research community, including authors, reviewers and journals.”
The increasing number of innovative anti-cancer treatments naturally leads to the use of observational studies to reduce the several gaps of evidence for various subgroups of patients. Hence the rapidly evolving field of RWE studies.
“While clinical trial populations are prone to selection bias, high-quality RWD may demonstrate the true effects of innovative trial results for the general population,” says Dr. Miriam Koopman, co-author and chair of the ESMO Real World Data and Digital Health Working Group, while outlining the benefits of ESMO-GROW for the scientific community, health authorities’ decision-making and, ultimately, the patients. “High-quality RWD will provide more insight into the increasingly small subgroups that we identify for which a randomised clinical trial is not feasible. All this will not only facilitate decision-making by healthcare authorities, but also benefit scientific research. Ultimately, clinical guidelines can be supplemented with high-quality RWD which can benefit patients by facilitating individualised treatment advice.”
Within the framework of the existing available publications, the ESMO-GROW introduces the consideration of modern technologies such as artificial intelligence, machine learning and deep learning, which are increasingly being instilled in the various phases of data analytics processes for RWE studies. Until now, the involvement of these technologies was only available in recent guidelines for interventional studies.
“ESMO-GROW includes diverse dimensions of modern RWE research in oncology, such as the growing utility of novel biomarkers and therapeutics, cancer data-sources, diverse study designs, emerging strategies for data sharing and interoperability or the growing utility of artificial intelligence also for cancer research,” Dr. Castelo-Branco concludes, confident that ESMO-GROW meets all the prerequisites that make it suitable to become a reference point and potentially a new standard for RWE research in oncology.
The recommendations listed in the ESMO-GROW manuscript are transposed online into an informative scoring checklist that can be used by the cancer research community to facilitate the writing, reviewing and publication of RWE studies. The interactive tool allows single recommendations to be browsed to keep track of whether they have been fully, partially or not applied to the RWE study in question, producing a final score which offers authors and reviewers an estimate of the level of completeness and accuracy of their reporting. The checklist is free and accessible from the new dedicated section of the ESMO website.
The “ESMO Guidance for Reporting Oncology real-World evidence (GROW)" manuscript is now published – and freely accessible – in both ESMO Real World Data and Digital Oncology and in Annals of Oncology.