FDA Provides a Path to Use RWE For New Approvals: Highlights Challenges With Doing the Same
[Posted on: Thursday, July 26, 2018]
Electronic health records (EHRs) provide a rich source of real-world health-related information which can be used as an electronic source data in clinical investigations. However, there are several conditions that one needs to meet before it would be acceptable to FDA. FDA has allowed use of electronic sources data (e-Source) for several years; the FDA guidance for e-Source describes e-Source can supplement or replace traditional source documents. The new guidance of using EHR generated outside clinical trials takes the e-Source guidance to the next stage of include real world data to collect Real World Evidence (RWE) to support new uses of previous approved products, as required by the 21st Century Cures Act. FDA acknowledges that EHR is outside its jurisdiction and that it does not need to meet the strict criteria of 21 CFR Part 11, however, it can still be used to collect and analyze data to support market approval. EHR is particularly useful for long term follow-up for safety and effectiveness by automatically populating relevant data fields in the electronic case report forms (eCRF). To do so, the sponsor must use “interoperable” or fully integrated systems which allow transfer of data from one to the other without much human interactions. To be acceptable, the EHR must follow data standards of the Office of the National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services (HHS) and must be validated. It is acceptable to import data from multiple EHR systems. If the EHR system is not certified by ONC, such as that from a non-US country, it can still be used provided adequate controls are in place to ensure the confidentiality, integrity, and security of data. These include measure to protect the data, data is entered by authorized users, adequate audit trails are maintained, and FDA can audit the systems. Although Part 11 is not applicable to the electronic health records, data derived from EHR should meet the Part 11 requirements. Sponsors should also consider issues related to blinding of the study and informed consent from patients. Overall, FDA is supportive of using RWE residing in electronic health records to collect data supportive of clinical data, to be eventually used for market approval provided it meets common sense criteria for quality. The document highlights the challenges of using EHR in clinical trials but also provides solutions to address them.