How Digital Data Capture is Transforming Healthcare Decision Making
By Tim Davis, Vice President, Digital Patient Solutions, ERT
Introduction
Assessing the value and effectiveness of new drugs is essential in the pharmaceutical industry, but how these important decisions are made has undergone remarkable change in recent years, alongside huge advances in technology. Only thirty years ago, new drugs were assessed mainly on their commercial value, with the focus shifting in the following years toward cost- and clinical-effectiveness. Since then, Real-World Evidence (RWE) and listening to the patient voice have become much more important.
Today, RWE and humanistic patient generated outcomes are key to guiding all stakeholder decisions, including regulators, physicians, payers, and patients themselves. For example, in a recent ISPOR survey, almost 90% of payers reported that they use RWE in decision making1. Much of this is due to the recognition that the gold standard of new drug assessments, traditional randomized controlled trials (RCTs), operate in idealized environments. They also measure efficacy in limited patient groups and thus cannot predict the effectiveness of new treatments in real-world settings.
Companies are increasingly implementing supplementary real-world programs, in which large groups of patients report their own health outcomes in real life settings over long durations. The resulting Real-World Data (RWD) feeds into RWE to inform decision makers about how effective new drugs are for patients as they go about their daily lives….