New Guidances: Use of Electronic Health Record Data in Clinical Investigations / E17 General Principles for Planning and Design of Multiregional Clinical Trials

1. Use of Electronic Health Record Data in Clinical Investigations: Final Guidance for Industry:

FDA has published a  guidance for industry entitled “Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry.” This guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards, and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations.  The guidance’s goals are to modernize and streamline clinical investigations through inclusion of real world data in clinical investigations and facilitate integration of clinical trials that occur in routine care settings.  In addition, we hope that the guidance will encourage sponsors and health care organizations to work with EHR and electronic data capture (EDC) system vendors to further advance the interoperability and integration of EHR and EDC systems.

2. E17 General Principles for Planning and Design of Multiregional Clinical Trials Guidance for Industry

The purpose of this guidance is to describe general principles for the planning and design of multiregional clinical trials (MRCTs) with the aim of increasing the acceptability of MRCTs in global regulatory submissions. The guidance addresses strategic program issues and issues that are specific to the planning and design of confirmatory MRCTs, and it should be used together with other ICH guidances for industry, including E5 Ethnic Factors in the Acceptability of Foreign Clinical Data, E6 Good Clinical Practice, E8 General Considerations for Clinical Trials, E9 Statistical Principles for Clinical Trials, E10 Choice of Control Group and Related Issues in Clinical Trials, and E18 Genomic Sampling and Management of Genomic Data.