Late-phase studies present a set of unique goals and challenges unlike those in earlier phase clinical trials. Because this brand of research strives to reflect the real world, study designs are varied, data may be unavailable, and the uncontrolled environment may present unexpected results. At the same time, there already may be a large body of data available on a given product or disease. As a result, existing information may be leveraged to limit data required to be collected for later phase research. To assemble a reliable data source in a late-phase setting, a strategic data management approach is necessary — and must incorporate some critical factors.
Steve Gulyas,?Ph.D. Senior Director, Late Phase Data Services, OptumInsight. OptumInsight specializes in analytics that enable better decisions throughout the health system. For more information, visit optuminsight.com.