News Feature | January 19, 2017

FDA Touts EvGen, IMEDS Programs Ensuring Patient Safety

By Jof Enriquez,
Follow me on Twitter @jofenriq

FDA Device Cybersecurity Guidelines

The U.S. Food and Drug Administration (FDA) unveiled a website for its National Medical Evidence Generation Collaborative (EvGen), intended to bring wider access to high-quality scientific evidence supporting the safe use of FDA-regulated products. The agency also launched a second resource, the Medical Evidence Development and Surveillance System (IMEDS), which helps FDA and outside researchers conduct large-scale evaluations of safety issues while protecting patients' private information.

The EvGen Collaborative aims to coordinate FDA-led efforts to collect data on diseases and therapies from electronic health records, insurance claims databases, registries, personal electronic devices, and social media to generate high-quality evidence that enables all healthcare stakeholders — doctors, patient, payers, industry, and government — to make informed decisions.

FDA Chairman Dr. Robert Califf and FDA Associate Deputy Commissioner for Medical Products and Tobacco Dr. Rachel E. Sherman wrote in a blog post that, with EvGen, "patients would benefit from a more comprehensive, patient-centered and evidence-driven approach that engages them as active participants in care and research. At the same time, practitioners and other healthcare professionals would have access to constantly growing sources of scientific evidence that would enable them to more confidently determine which treatments work best for which patients. And payers would have the information needed to identify which treatments truly provide value to those they cover."

During his short tenure at the helm of FDA, Califf has advocated for evidence generation and real-world evidence due to their potential to reduce the burdens of obtaining appropriate evidence across the life cycle of a medical device, during clinical trials and the post-market phase, in particular. The EvGen Collaborative helps to realize that potential by allowing clinical research to be "embedded seamlessly within real-world clinical practice," bringing about "a continuously learning healthcare system," wrote Califf and Sherman.

Also helping FDA to monitor medical products' safety and effectiveness after they hit the market is the Sentinel Initiative, FDA’s national electronic system that collects information from electronic health records (EHR), insurance claims data, and registries to monitor the safety of drugs, vaccines, biologics, and medical devices. Since launching Sentinel in May 2008, FDA has utilized its huge amounts of data to better inform regulatory decisions. 

Now, FDA wants Sentinel's healthcare data, epidemiologic studies, and scientific tools and methods to become available for entities outside of FDA who want to conduct important research to advance patient safety. FDA believes it has created such a resource/framework with IMEDS, a public-private partnership by the Reagan-Udall Foundation for the Food and Drug Administration, a not-for-profit organization created by Congress in 2007 to advance regulatory science.

Researchers across the U.S. can now access IMEDS' modular programs, as well as customized epidemiologic studies, to investigate safety issues. According to Califf, IMEDS offers the following benefits:

  • The large underlying distributed database offers privacy-protected information about medical products used by millions of patients. The data are quality checked to FDA standards and formatted using the same common data model used by FDA.
  • Modular programs incorporate epidemiologic methods and computer software templates that are routinely used by FDA.
  • Years of collective experience with distributed drug safety analyses, amassed by analytic center and data partner staff, provides critical context for new IMEDS users.
  • IMEDS ensures transparency, with detailed descriptions of analytic decisions and publication of results in sufficient detail to promote replication by others.

"FDA is confident that IMEDS sponsors will play a key role in shaping the future of evidence generation to help answer outstanding questions about the safe and effective use of medical products in a broad range of populations," wrote Califf.