PHARMACEUTICAL ADVERTISING AND REAL-WORLD EVIDENCE
CD: 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.
CD: What factors have increased RWE’s profile in recent years?
Newstead: The growing acceptance of the validity and value of RWE has supported a significant increase in its profile and use, particularly with a recognition that RWE can validly sit alongside randomised control trials (RCTs) and provide a much broader scope of evidence that cannot be obtained from RCTs. The increased use of technology in the healthcare sector has also influenced the growth and the demand for RWE. The development of new technologies such as wearable devices, together with increasing use of data-collecting medical devices within the home, all provide fruitful sources of information.
Jan-Mar 2022 issue
Shook, Hardy & Bacon International LLP