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Utilizing the 'Crowd Trial' for Pharmacovigilance: a case report


Singulair (MONTELUKAST SODIUM) is a Leukotriene receptor antagonist, indicated to prevent asthma attacks in adults and children. It is also used to relieve allergies in adults and children. Singulair was approved by the FDA in February 20, 1998. In March 2008 the FDA informed healthcare professionals of investigating the possible association between Singulair usage and behavior/mood changes, suicidality and suicide. First Life Research [FLR] identifies, analyzes, indexes and aggregates user generated content by collecting billions of testimonials from social networks. It utilizes cutting edge technologies for massive data aggregation, and applies advanced Natural Language Processing (NLP) techniques for continuous analyses, in order to convert this unstructured data into refined information. With a large population sharing experiences regarding health issues and treatments online via social media platforms [Health 2.0], generating novel data sets comprised of massive unstructured user generated content of health reports. This collective intelligence is referred to as the 'Wisdom of the Crowd' or the 'Crowd Trial'. Unlike regulated formal post marketing reports, the crowd trial takes place spontaneously, continuously and on a very large scale. This Crowd Trial provides a snapshot of health trends and has become a proxy of post-market clinical trials of medications and other therapies.


The purpose of this case report is to demonstrate how applying an additional data source originated from e-patient reports, helps support drug surveillance and Pharmacovigilance processes.

Submitted by elamb on