Regulatory Briefs: U.K. Trials Database; Hospitals Seek UDI Rule; FDA Workshops

The Health Research Authority, an arm of the U.K.’s National Health Service, is implementing plans to make registration in a publicly accessible clinical trial database a condition of gaining approval from an ethics committee starting Sept. 30. In a Sept. 11 announcement, Janet Wisely, chief executive of HRA, said, “We are fully committed to the principles of transparency in health research. Including a requirement for registration as a condition of the favorable ethical opinion is a significant step towards this.” Failure to register will be a breach of good research practice. The mandated trial registration will initially apply to clinical trials of medical devices and investigational medicinal products. HRA expects all studies to be registered when the first patient is recruited, and will be considered breached if trials aren’t registered within six weeks of patient enrollment. The group expects current and previous studies as well as future studies to be registered in the database.

The Healthcare Transformation Group, composed of five health care systems, sent a letter Sept. 6 to the White House Office of Management and Budget urging the office to release the unique device identifier final rule. OMB was sent the final rule by FDA for review on June 11. (See Also see "Regulatory Briefs: OMB Updates On UDI, eMDR Rule; Circ Panel Scheduled" - Medtech Insight, 19 August, 2013..) The group, composed of Kaiser Permanente, Mayo Clinic, Mercy, Geisinger Health System and Intermountain Healthcare, said, “Further delays finalizing the UDI rule will only postpone the significant benefits to patients and health systems afforded through UDI implementation. We fully support release of the UDI regulations, and expect to promptly incorporate this new device identification system into a number of key processes