4 Steps the FDA plan to take to improve the use of AI and RWE in clinical trials

In a recent speech at the Bipartisan Policy Center conference, FDA Commissioner, Scott Gottlieb, discussed how the future success of clinical trials will be underpinned by new streams of real world data (RWD). This includes information collected from electronic health records, lab tests, wearable devices, insurance claims and even social media. As he made clear, "digital technologies are one of the most promising tools we have for making health care more efficient and more patient-focused". The FDA believes that these new approaches to collecting data and the utilization of new technology can radically expand the sources of data available. This will offer important evidence on both the product safety and effectiveness in settings and populations that are notably different to those used within approved trials.