Maintaining patient registries, on the basis of which regulatory authorities can make decisions regarding medicines

Abstract

The use of data and evidence from real clinical practice (RWD / RWE) is becoming more and more relevant to the healthcare system when making critical decisions in the field of drug circulation regulation, as well as making decisions on the inclusion or non-inclusion of a drug in government funding programs.

This article discusses the role of clinical registries as one of the most important sources of RWD / RWE. Definitions of terminology are given, and various types of registers are described according to the type of information collected, methods of its collection, storage, and processing. It also shows the possibility of using registers in decision-making, describes the mechanisms for consolidating information from various types of registers, as well as obtaining data for analysis from other sources, shows the importance of correct collection and validation of data collected in the register.

The article also briefly describes the local experience in the development, implementation, and maintenance of registers on the example of a number of disorders.

It was prepared using guidelines prepared by the Office of Medical Policy of the Center for Drug Evaluation and Research in collaboration with the Center for Biological Evaluation and Research and the US Food and Drug Administration»s Center of Excellence in Oncology.