Report on EU IVD Regulation Calls for Stricter Controls Over Clinical Trials, Genetic Testing

The European Commission should specify provisions for inspecting clinical trials of in vitro diagnostic devices and not leave oversight to the discretion of EU member states, a draft report by a member of Parliament says.

“This could lead to decisions on whether to monitor an investigation being made dependent upon the availability of appropriate budgetary means [and] …result in clinical investigations being carried out preferentially in states which dispense with monitoring,” the report, by Peter Liese, rapporteur for the Committee on the Environment, Public Health and Food Safety, says.

The report also calls for protections for minors and other persons not able to give informed consent to be aligned with protections in the 2001 clinical trials directive.

Clinical performance studies of IVDs should be approved by an independent ethics committee before getting underway, the report adds.

Liese proposes extending the timeline for regulatory authorities to notify sponsors whether a trial application is complete from six to 14 days after receipt of the application. The timeline for notifying sponsors of the receipt of comments or a completed application is extended to seven days, from three.

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