The Polish Pharmaceutical Group asked BioStat experts to perform statistical analysis of real data. The scale of the project was remarkable. The analyzed data came from the THIN (IQVIA) database from over 100,000 anonymised patients living in Great Britain.
The client's goal was to compare the efficacy and safety of combination therapy with monotherapy in patients with arterial hypertension. At a later stage, the willingness to use the results of the analyzes as the basic supporting evidence in the process of applying for approval to introduce combination pills with 2 active substances on the British and other markets of the EU member states.
The number of analyzed variables determined the use of Big Data analysis methods. Working on the project was a complex process involving several entities (Sponsors, Database Owner, BioStat, Medical Writers, Approval Committee, Regulator).
Before starting the data set analysis process, it was necessary to define the purpose, scope of data to be analyzed, as well as the possibility of their use in practice, and to compare the effectiveness of various therapeutic options in a given indication. In practice, the first retrospective study protocol was developed with approval from the Scientific Research Committee. After accepting the protocol, the database owner trained our team and the databases were handed over. BioStat performed a number of analyzes that supplemented the content of the final report.
Considered as cutting edge in the pharmaceutical sector, the project provided a better understanding of the positive and negative effects of therapy switching and highlighted the practicality of applying such huge datasets to research.