Clinical Informatics News recently reported that “Real-world data sources are combining with traditional data sources—clinical trials, electronic medical records, genomic data, insurance claims, streaming connected devices, social media, meteorological data, and patient reported data—to offer a wealth of possible applications. And now maturing technologies like machine learning and algorithmic methodologies can make sense of these big, noisy, complicated datasets. Together, these data sources and analytic technologies seek to answer what treatments work for whom, why, in what context, and at what cost.”
PDG has seen this coming for years and believes reliance on RWE is growing in acceptance. Our Epidemiologist has extensive experience in supporting clinical and safety findings through the use of patient records derived from publicly available sources/databases (e.g. AHCA). PDG has utilized his work in support of PREA waivers, labeling changes, and reduction of toxicology and clinical requirements.
According to FDA, “Medical product developers are using RWD and RWE to support clinical trial designs (e.g., large simple trials, pragmatic clinical trials) and observational studies to generate innovative, new treatment approaches…The 21st Century Cures Act, passed in 2016, places additional focus on the use of these types of data to support regulatory decision making.”
Here’s a link to the Clinical Informatics News story and a link to FDA’s latest thoughts on the topic.
RWE doesn’t just apply to drug development. On August 31 FDA Issued “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.” Here’s a link. Finally, contact us about how to include RWE in your next drug or medical device submission.