Big data in drug safety
Making Post-Marketing Surveillance of Pharmaceuticals More Efficient
April 2014
Abstract—According to the 1997 report from Erice, Sicily, ‘drug safety information should be ethically and effectively communicated in terms of both content and method’, ‘all the evidence needed to assess and understand the risks and benefits must be openly available’, and ‘exchange of data and evaluations among countries must be encouraged and supported’. To address the risk of data leaks and to facilitate real time detection of safety signals, aggregate data rather than individual case reports (ICSRs) would be more appropriate to meet the need for analysis of large volumes of information on benefit:risk profile of medicinal products by health care professionals and the public. Pharmaceutical industry can be safely left out from assessment of spontaneously reported ICSRs for potential causal relationship between suspected adverse drug reaction (ADR) and associated drug from post-approval use. Providing aggregate data to stakeholders not directly involved in patient care would be fit for purpose; and could be extended to systematic assessment of treatment outcomes from the whole population rather than detection of safety signals from small fraction of adverse drug reactions which are reported spontaneously. Information on individual case histories would remain a private matter between the patients and their health care providers. The paper makes a case for change in the way data on safety of medicines is collected, structured, analyzed, visualized, and shared; moving away from the system of active reporting of individual case reports into national and international databases, toward collection and analysis of anonymous structured summary data from health care providers, in order to allow analysis of total numbers of treated patients and treatment outcomes; including adverse drug reactions and off-label drug use, to provide meaningful, population-based, statistically valid, bias-free, real-time information on safety and efficacy of products on the market without endangering patients’ privacy. Such approach would significantly reduce privacy concerns and add value for stakeholders who are interested in timely and accurate information on benefit:risk profile of medicinal products.
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