Real-world evidence studies in oncology: a trend or a necessity?

The advent of anticancer drugs has greatly influenced the treatment of patients with advanced cancers. The development of this area of medicine is constantly gaining momentum and the number of new drugs is increasing every year. The emergence of a new anticancer drug in clinical practice is preceded by a determination of its efficacy and safety in preregistration clinical trials. The classic, and well-established, tool for generating such evidence is randomized clinical trials (RCTs). However, they have a number of disadvantages, such as high cost, duration, strict selection of patients according to certain clinical criteria, which make it difficult to extrapolate the results to the entire population. In addition, in recent decades, many authors point to the negative trends occurring with RCTs in oncology. Real-world evidence studies provide additional data on the drug, which is of particular importance in oncology. Like any tool, they have their limitations and problems that require a balanced approach in their implementation. Despite the high interest, both from researchers and regulatory authorities, at the moment there is no generally accepted international approach regarding the methodology for conducting and the legal status of such studies. Regulatory authorities around the world are taking active steps to introduce real-world evidence studies for decision making. This trend is also supported by the Russian Federation, which has recently taken the first steps in this area.