Clinical Genomic Analysis Workshop 2012

Sunday May 13, 2012
Organized by IBM Research – Haifa and Edmond J. Safra Center for Bioinformatics at Tel-Aviv University

A current trend in the pharma world—real-world evidence (RWE)

In the healthcare process, decisions are made on every level, from the treatment of individual patients to the formulation and evaluation of national policies. Faced with scientific and economic challenges along with the availability of data collected in actual practice, captured either by electronic data systems such as electronic health records or produced via high-throughput technologies, RWE aims to use data to inform healthcare decisions. Specifically, RWE is a shift in the timing and use of data that aims to revise product labels and usage guidelines to better target diseases and hence improve treatment therapies. Fundamental aspects of real-world evidence include the comparative effectiveness of medicines and medical treatments, the identification of safety issues and comparative safety profiles of medical products, and drug repurposing. Access to providers' data is thought to hold the potential to inform these aspects of RWE. Issues associated with unlocking this potential include type and evaluation of evidence that will be extracted from these data and the development and application of algorithms that facilitate evidence generation regarding the effectiveness of medicines and medical treatments. Other issues include the identification of potential subgroups for which medical treatments are most effective, the identification of adverse events that are causally associated with specific medical products, and the possibility of finding new indications for medicines with known safety profiles. Given the rapid development of machine-learning methods and technologies to extract and evaluate evidence from large-scale multi-modal data sets, these issues must be considered accordingly. Pharmaceutical companies have likewise been recently focused on real-world evidence studies.