Everyone talks about “big data”, and how it is going to transform many industries, including healthcare. In a recent work, Bate, Reynolds, and Caubel analyze and describe the achievements of big data approaches in pharmacoepidemiology, improvement on quality of data for drug safety research, and the role of big data in relation to the identification of potential safety signals in post-market surveillance, that is, the impact of big data on quantitative signal evaluation and the identification of potentially new safety signals.
In pharmacovigilance and signal detection, we have moved quickly from manual, paper-based methods for signal detection to spontaneous reporting systems that require electronic submission, but allow quantitative and qualitative analyses as part of signal management systems.
According to the authors:
While the core of regulated pharmacovigilance practice still centers on the collection of individual case safety reports, change is occurring, in part as a result of Big Data approaches. The greatest change in pharmacovigilance analytics being applied today, and the one most connected to the Big Data revolution, is the more sophisticated use of observational data, as evidenced by pharmacoepidemiologic studies conducted across multiple databases and the development of large networks of observational databases of Electronic Healthcare Records in North America.
The new pharmacovigilance analytics will go beyond safety assessment. It will provide value for research too. Examples will be comparative effectiveness studies, pragmatic trials or investigational trials in real-world settings. The FDA Sentinel Initiative is a clear example of this new approach.
The authors also talk about what is known as hypothesis-free signal detection with its advantages and limitations, consumer wearable technology for pharmacoepidemiologic research, the new data streams and technologies as a source for identifying potential new safety signals, and the need to critically evaluate the impact of innovative data sources and techniques.
For more information check out the complete article from Therapeutic Advances in Drug Safety.
Read the source article here: The hope, hype and reality of Big Data for pharmacovigilance.
