In Focus: The role of big data in the drug development process

As big data plays an increasing role in drug development and clinical trials, The Pharma Letter’s Bethany Rutter spoke to Richard Young, vice president, mid-market EMEA at Medidata, which provides clinical research organizations and companies with highly advanced technological tools for planning and managing clinical trials.

Clinical trials are becoming more and more complex, with ever-greater political, ethical and economic responsibilities. Time is money: drug developers must maximize resources and time by ensuring they get the right patients on the right trials, and carrying out the right assessments, in order to give the best chance of providing a successful outcome at the end of the study. The financial pressure of doing more with less means that companies are continually reviewing their processes and practices. It is no longer good enough that a medicine works in 95% of the population; developers need to be able to give 100% certainty that their product is up to scratch.

Data capture and tracking in the clinical trial process has historically been a challenge, as it was generally only readable by humans and carried out on paper. Now, in a digitally-focused industry, everything is electronic, which means it is accessible and available for reporting much earlier in the process. From the days when it would take 10 weeks between a patient seeing the investigator and the data becoming available, that has now been shortened to a matter of hours and minutes. This disparate and paper-based way that reporting was done in the past meant it was often difficult to gain a comprehensive view of how the trial is going at any one time. An easily accessible overview that allows data to flow freely between all platforms ensures that any decision-making is based on the most up-to-date data.