Abstract
Real world evidence (RWE) and real-world data (RWD) are drawing ever-increasing attention in the pharmaceutical industry and drug regulatory authorities (DRAs) all over the world due to their paramount role in supporting drug development and regulatory decision making. However, there is little systematic documentary analysis about how RWE was integrated for the use by the DRAs in evaluating new treatment approaches and monitoring post-market safety. This study aimed to analyze and discuss the integration of RWE into regulatory decision-making process from the perspective of DRAs. Different development strategies to develop and adopt RWE by the DRAs in the US, Europe, and China were reviewed and compared, and the challenges encountered were discussed. It was found that different strategies on development of RWE were applied by FDA, EMA, and NMPA. The extent to which RWE was adopted in China was relatively limited compared to that in the US and EU, which was highly related to the national pharmaceutical environment and development stages. A better understanding of the overall goals, inputs, activities, outputs, and outcomes in developing RWE will help inform actions to harness RWD and leverage RWE for better health care decisions.
Highlights
Real-World Data (RWD) refers to the data obtained through multiple sources, which is related to patient health status or delivery of health care and medical behavior in routine clinical practice [1, 2]
The findings presented in this study are not exhaustive as updates about Real-World Evidence (RWE) development emerges regularly, (b) to the authors’ knowledge, all relevant information from the Food and Drug Administration (FDA), European Medicines Agency (EMA) and NMAP repositories was gathered but the manual data-mining process precludes absolute certainty, (c) regarding the findings about the European countries, the study primarily focused on the RWE development promoted by the EMA and actions and initiatives taken by national competent authorities in the region included in this study was limited, (d) all the results and conclusions were based on the publicly available information at the FDA, EMA, and National Medical Products Administration (NMPA) repositories, which represents a fraction, but estimated as the most significant perspective, of the overall RWE development in the countries/regions
By systematically retrieving and comparing RWE related information from different sources including the drug regulatory authorities (DRAs)’ official websites and academic databases, it is shown that significant progress has all been made in the development of RWE in the United States (US), Europe Union (EU), and China
Summary
Real-World Data (RWD) refers to the data obtained through multiple sources, which is related to patient health status or delivery of health care and medical behavior in routine clinical practice [1, 2]. Data sources include electronic health records (EHR), medical claim data, medical databases and patient information collected from various devices. Real-World Evidence (RWE) denotes the analysis of clinical research evidence generated by RWD related to the use of medical products and potential benefits or risks. The definitions and applications of RWE are closely linked to the development of national healthcare policy and to the regulatory science [3]. Regulatory approvals of new drugs have always been largely, if not solely, based on randomized clinical trials (RCTs). The rigor of RCT study design mandates a set of eligibility criteria for subject inclusion and exclusion to ensure homogeneity and representativeness of the studying findings [4]
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