Navigating Real-World Evidence Reporting Guidelines

Abstract

Real-world evidence (RWE) has gained traction over the last several years and is now an integral part of the drug approval process\ and life cycle. Conducting well-designed studies and transparent reporting of studies has recently become the focus of guidance issued by multiple regulatory agencies and professional organizations across the globe. Knowledge of the available resources is paramount for medical writers. Although the first guidance, STROBE, dates back to 2007 and was widely known for its checklist for the reporting of observational studies, the advancements in electronic medical records, disease registries, and administration necessitated the development of the Reporting of Studies Conducted Using Observational Routinely-Collected Health Data (RECORD) guidance. ISPOR, the Professional Society for Health Economics and Outcomes Research and the International Society for Pharmacoepidemiology have developed guidance specific to the reporting of RWE studies and provided a template to assist with the description of longitudinal studies using routinely collected health care data. Although these options are helpful for a general approach to RWE reporting, other organizations like the European Society for Medical Oncology have recognized the need for guidelines for disease- specific research and have developed more specific guidance. Navigating the resources that are available is imperative for medical writers. This paper provides a guide to relevant contemporary resources to aid medical writers in the reporting and publication of RWE studies. Because of the expansiveness of the types of studies that fall under RWE, this paper focuses on traditional RWE studies that employ a longitudinal approach to the analysis of routinely collected health care data.