EU regulators have developed a draft good practice guide explaining how stakeholders can make use of the Metadata Catalog of RWD Sources, which is expected to be released in late 2023, to identify appropriate sources for specific research questions.

An updated Q&A on the EU Clinical Trial Regulation distinguishes between patient-facing documents and recruitment material to clarify in which sections of the trial application these should be submitted. It also underlines the main principles to consider for transitioning studies from the Clinical Trials Directive to the CTR.

A further extension of the EU signal detection pilot means that certain drug sponsors must keep monitoring the EudraVigilance database on a continuous basis. Industry argues there is enough evidence that this activity brings no additional value, and that current requirements should be replaced with a more proportionate approach.

Following feedback from its clinical trials expert group, the European Commission has published new and updated templates that sponsors can use to prepare study applications that would be acceptable in all the EU member states.

A compilation of the differences and similarities in regulatory requirements for decentralized trials across the EU member states could help sponsors better understand the nuances per country.

Drawing on lessons learnt from unprecedented interruptions to clinical trials over the past few years due to such things as the pandemic and the war in Ukraine, new advice has been issued on adjustments needed in clinical study reports to document these disruptions.