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Clinical Trials – Real World Evidence

Real-World Evidence (RWE) trials are crucial for further understanding newly approved medicinal products in the real-world setting. These trials provide clinical evidence of the long-term safety and efficacy of these drugs from real-world data where patients are treated using these drugs. RWE trials mainly involve observational data outside the traditional involvement of randomized controlled trials. Using real-world data is an integral part of RWE trials as it allows researchers to monitor and assess patient outcomes and treatment methods. It also allows for the effects of a medicinal product to be investigated over a long period of time.


The clinical trials data used for these analyses were extracted from GlobalData’s Clinical Trials Database. The report focuses on RWE trials where the data was sourced from the clinical trial database and all clinical trials were initiated between 2001 to 2021. The data have been analyzed by year, phase, status, therapy area, indication, geography, sponsor type (top industry sponsors versus non-industry sponsors), and reasons for discontinuation. In this report, a small number of Phase 0, Phase I/II, Phase II/III, and Phase III/IV trials were combined with Phase I, Phase II, Phase III, and Phase IV trials, respectively.

Reasons to Buy

Understand how RWE trials are beneficial

The trends of RWE clinical trials

Global uptake and usage of RWE trials

Table of Contents

Tables and Figures

Executive Summary


Clinical Trials Landscape of Real-World Evidence Trials

Key Findings


List of Tables

Table 1: RWE Trials by Drugs

Table 2: Post Marketing Commitments

Table 3: RWE Developments by Regulatory Agencies

List of Figures

Figure 1: Number of RWE Trials by Sponsor Type and Year

Figure 2: RWE Trials by Phase and Status

Figure 3: RWE Trials by Regional Distribution

Figure 4: Single-Country & Multinational Real-World Evidence Trials by Region

Figure 5: Distribution of RWE Trials by Top 5 Countries

Figure 6: RWE Trials by Therapy Area

Figure 7: RWE Trials by Indication

Figure 8: Reasons for Trial Discontinuation of RWE Trials

Figure 9: Top Industry Sponsors for RWE Trials

Figure 10: Top Non- Industry Sponsors for RWE Trials

Figure 11: Virtual Trial Components

Figure 12: RWE with Virtual Trial Component by Therapy Area

Figure 13: Device Layers


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