Analytics on Trial - the use of Analytics in Global Clinical trials

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:

Analytics on Trial - the use of Analytics in Global Clinical trials

Key performance metrics across global sites can be accessed in real-time to ensure they are performing up to par.
Sponsors can use self-service business reports to get more insight into patient screening, recruitment and retention, which in turn can boost clinical trial efficiency.
Analytics can reveal bottlenecks that may exist at various sites, including slowdowns in investigator sign-offs of Electronic Case Report forms.

Another area where Analytics can help is in the use of social media. While many organizations already use social media to recruit patients for clinical trials, they are eager to explore further ways to leverage it. Pfizer, for example, is launching a virtual drug trial using smart phones and web-based technology to collect data on the safety and efficacy of Detrol LA, an overactive bladder drug. Patients can enroll online, have materials delivered to their homes, manage their own trial activity at a secure website, and report results to a trial investigator by these means.

Have you used Analytics to gain greater insights from your global clinical trials? If there are any challenges that you'd like to discuss with us, don't hesitate to write in.

About the Author

Rajeshwar D Mitra (RD) has been with Wipro for the last 5 years. In his earlier roles in EAS, RD managed the SAP global alliance and was responsible for Wipro being chosen as a Global services partner of SAP. Thereafter he led the Supply chain practices in EAS and was responsible for driving significant value added growth. Prior to joining Wipro, RD has had over 16 years consulting and technology in organizations such as PricewaterhouseCoopers and IBM Business Consulting Services along with an entrepreneurial stint.

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