Paper short abstract:

RWD are framed as an alternative form of evidence, which can supplement or even replace Randomized Control Trials. In this paper, I map out what counts as RWD and how these data are used in order to understand how they shape the knowledge produced about the world.

Paper long abstract:

Real-world data (RWD) refer to routinely collected data relating to patients’ health status and the delivery of health care originating from a range of sources other than traditional clinical trials. Examples of RWD include electronic health records, patient registries or personal information collected from wearable devices. RWD are often used in particular epistemic projects, the pharmaceutical industry relying more and more on observational data such as health records instead of experimental data one would gain as part of Randomized Controlled Trials (RCT) to learn about the effectiveness and safety of medicines. In such instances, RWD are framed as an alternative form of evidence, which can supplement or even replace RCTs. This shift greatly impacts what we consider ‘good’ science and objectivity in research. In this paper, I begin mapping out what counts as RWD and how these data are used in order to understand how they shape the knowledge produced about the world. Crucially, I explore how the use of RWD challenges the established hierarchy of evidence within healthcare, and discuss its implications for evidence-based medicine.