Masterarbeit

Regulatory grade RWD/RWE data quality for drug discovery and development

Zhivko Krokodilov (2025)

Summary

Language: English

In the context of the fast pace of digitization nowadays, the real-world data are increasingly getting into the focus of the healthcare research. The availability of large volumes of data at the right time gives hope that research questions can be answered quickly without the collection of additional data in order to achieve a direct benefit for people and the care provided to them.

To enable proper use of RWD and RWE and their implementation into of process of drug development or to support regulatory decision making, ensuring the high-quality of the data in all of its dimensions and meeting the stringent regulatory standards, is critical. 

The objective of this Master-Thesis is to provide an overview on the RWD and RWE data quality parameters and dimensions, based on conducted analysis of published evidence, and to give recommendations on these areas and quality features of the RWD, which could help to cover the unmet needs of the data quality to generate Regulatory grade RWE. To address this, a Literature search in Embase was conducted, along with web research including literature and websites and the results were screened and analyzed. 

The document provides a definition for the RWD and RWE, describes the RWE sources, along with their quality considerations, examples on the application of RWD and RWE during drug discovery, for drug development and in support of Regulatory decisions making and the challenges associated with the use of the RWD and RWE. 

The review covers results from the EMA and FDA guidelines and literature references, the quality of data, its reliability, the respective data quality features and the processes, which need to be addressed for the establishing a fit-for-purpose RWE. 

Finally, a recommendation is provided for the areas and quality features of the RWD which require special attention and which could help to cover the unmet needs of the data quality to generate Regulatory grade RWE. 

Pages: 76