What is Real-World Data?
The Association of the British Pharmaceutical Industry (2016) defines real-world data as ‘that collected outside the controlled constraints of conventional randomised clinical trials to evaluate what is happening in routine clinical practice’. Although the ‘gold’ standard in determining efficacy and reliability, clinical trials are rigidly controlled and microcosmic representations of the population. Consequently, it is argued that in isolation their outcomes lack the degree of generalisation appropriate to informing broader clinical and pharmaceutical practice.
The benefit of RWD resides in its independence from the restricted ambit of clinical trials delivering topical data as experienced by the patient in a real-time context. Thus the data can inform on treatment effectiveness, provide insights into differential care regimens, long-term drug safety, optimal healthcare utilisation and clinical epidemiology. Such criticality has positioned RWD as probably the most important benchmark in healthcare decision-making in the 21st century.