Drug Discovery & Development, www.ddmag.com, November 2014: Biopharma is increasingly harnessing the power of data collected outside of a controlled clinical environment to generate valuable insights to support throughout their lifecycle. Recent advances, such as greater availability of information technology and stronger observational research methods, have improved out ability to leverage real-world data sources, making them attractive tools for research use. As we continue to investigate and use these sources to strengthen evidence of real-world safety and effectiveness and influence value-based purchasing and pricing, we recognize the importance of selecting the right data source and study design for a given research question. Given the number of potential clinical data sources and their increasing availability for research, selection of an appropriate source is challenging. Here we examine how to best leverage these data in today's complex environment.


Authors: Christina Mack, PhD, MSPH, Associate Director, Epidemiology, Real-World & Late Phase Research, Quintiles, and Kathy Lang, PhD, Senior Director, Emerging Businesses Data & Analytics, Real-World & Late Phase Research, Quintiles