The following excerpt is via Corporate Disputes' one-on-one interview with Partner Alison Newstead. The full article is available in PDF below.
Corporate Disputes: Could you provide an overview of real-world evidence (RWE) and its application in the pharmaceutical industry?
Newstead: In the context of the pharmaceutical industry, real-world data (RWD) is observational or non-interventionist research, commonly collected via electronic heath records, disease and patient registries and other healthcare technologies. Data collected in this way is often very broad and is considerably different in nature to that which is collected in a formal, and more regulated, clinical trial setting. Information produced as a result of the analysis of RWD is defined as real-world evidence (RWE). The pharmaceutical industry has long recognised that RWE can be usefully applied across the entire product lifecycle, and it is increasingly used by the industry and regulators to inform their decision making. Potential applications in this field are extensive. For example, prior to the marketing of a product, RWE can be useful in assessing the progression of a particular disease and treatment patterns. Post launch, RWE can provide valuable information to regulatory authorities in order to evaluate safety, efficacy and cost-effectiveness and assist pharmaceutical companies with issues such as pharmacovigilance and proposed label extensions.