Maximizing the impact of real-world evidence on cancer treatment: what do we need to achieve it?

There is an increasing number of studies using real-world data to examine outcomes of drugs in clinical practice. Therefore, it is crucial to carefully evaluate their quality and findings, extract valuable insights, acknowledge their limitations and identify gaps to advance further their use in decision-making. Here we provide an overview of the opportunities offered throughout drug lifecycle, and challenges presented by real-world evidence (RWE) studies. We also highlight the importance of the culture of transparency, along with the development of good practices for reporting RWE studies. In addition, we review common biases and other methodological aspects that can undermine the potential insights a real-world oncology study can provide. We briefly illustrate some questions that RWE studies address that can help us guide clinical decisions. Several possible future directions expected to contribute for RWE improving cancer patients' outcomes emerge, from prospective data collection initiatives to normalization of biomarker data integration or collaborative data sharing platforms.