From Pharmacovigilance to Clinical Care Optimization

Leo Anthony Celi, Edward Moseley, Christopher Moses, Padhraig Ryan, Melek Somai, David Stone, Kai-ou Tang
2014 Big Data  
In order to ensure the continued, safe administration of pharmaceuticals, particularly those agents that have been recently introduced into the market, there is a need for improved surveillance after product release. This is particularly so because drugs are used by a variety of patients whose particular characteristics may not have been fully captured in the original market approval studies. Even well-conducted, randomized controlled trials are likely to have excluded a large proportion of
more » ... viduals because of any number of issues. The digitization of medical care, which yields rich and accessible drug data amenable to analytic techniques, provides an opportunity to capture the required information via observational studies. We propose the development of an open, accessible database containing properly de-identified data, to provide the substrate for the required improvement in pharmacovigilance. A range of stakeholders could use this to identify delayed and low-frequency adverse events. Moreover, its power as a research tool could extend to the detection of complex interactions, potential novel uses, and subtle subpopulation effects. This far-reaching potential is demonstrated by our experience with the open Multi-parameter Intelligent Monitoring in Intensive Care (MIMIC) intensive care unit database. The new database could also inform the development of objective, robust clinical practice guidelines. Careful systematization and deliberate standardization of a fully digitized pharmacovigilance process is likely to save both time and resources for healthcare in general. Limitations of Clinical Trials In the quest for the safe and effective use of pharmaceuticals, there is a pressing need for improved surveillance to reduce the risk of preventable morbidity and mortality after products are released. Clearly, such pharmacovigilance represents a form of care optimization as postrelease safety cannot be maximally assured even by excellent premarket studies. This is particularly so because these agents are prescribed to patient populations that are often not completely represented in the original studies required for market approval. Randomized controlled trials (RCTs), the gold standard for defining drug efficacy and safety profiles, are often of inadequate duration, are too narrow in indication and scope, and consist of relatively few test subjects. 1 Therefore, RCTs are ill-equipped to fully unravel heterogeneity of treatment
doi:10.1089/big.2014.0008 pmid:26576325 pmcid:PMC4630790 fatcat:rd2fialelnbrteosgehqpcj3cy