ESMO Guidance for Reporting Oncology real-World evidence (GROW)
Cet article présente les recommandations de l'"European Society for Medical Oncology" pour améliorer la qualité des publications des études utilisant des données de vie réelle en cancérologie
INTRODUCTION : The use of real-world data (RWD) for generating real-world evidence (RWE) to complement interventional clinical trial-based research is rapidly increasing. This evolving field is particularly prevalent in oncology with a growing number of publications and increased use of RWD in medicine regulation in recent years.1, 2, 3, 4 Improving the quality of RWE is crucial for patients, the scientific community and health care authorities.
Several guidelines have been developed in recent years that are...
METHODS : A comprehensive literature search of the existing guidance for reporting RWE studies confirmed the unmet need for specific oncology guidelines. A first draft of ESMO-GROW was developed by four authors based on the literature search. A second draft incorporated feedback from an expanded group of co-authors, including interdisciplinary experts in clinical oncology, statistics, AI, digital health, public health, pharmacology, research methodologies, health databases, guidelines development, health
RESULTS : The author group developed 35 reporting recommendations relating to each section of a RWE publication, including (i) title, (ii) introduction, (iii) methods, (iv) results, (v) discussion and conclusions, and (vi) final considerations. These recommendations are summarised in Table 1 and explained below. To complement the recommendations, lists of the definitions of key terms, main variables for RWE research in oncology and common sources of bias in RWE studies are provided in Supplementary
Annals of Oncology , résumé, 2022