The failure of AstraZeneca's blood thinner Brilinta, for which clinical trials were conducted in 43 countries, to win approval from U.S. regulators -highlights the importance of Analytics in Clinical Trials. This drug was rejected pending additional data analysis to understand the differences in outcomes between North American patients and those in other parts of the world. Such delays of potential blockbuster drugs in major markets, of course, aren't good for revenue growth, and certainly not at a time when a company's existing best-selling drugs are facing the pain of generics competition.
As clinical trials go global, facing international compliance issues often comes down to a matter of data - to document date, quantities, batch/serial numbers, expiration dates, and protocol-specified doses; and so on. For trial sponsors, data collection and management in the emerging market space can be a big concern.
The UBM TechWeb-Wipro study, The State of Clinical Trials, brought out some interesting findings on the use of Analytics in gaining a better understanding of data accumulated during the testing phases. We found that careful database analysis planning along with the design and use of analysis databases and statistical support services, can greatly help in interpreting and analyzing the data. Our study showed that Analytics can help mitigate some of these challenges: