In collaboration with the EMA and the European Union, the Heads of Medicines Agencies (HMA) issued a guideline called ‘Recommendation Paper on Decentralised Elements in Clinical Trials’.

More and more, clinical trials on Investigational Medicinal Products (IMPs) are using procedures conducted outside the traditional ‘clinical trial site’, a concept usually referred to as decentralisation. In addition, there is increasing use of digital tools within clinical trials. The COVID-19 pandemic highlighted the importance and usefulness of digital tools and decentralised procedures in a healthcare setting and in clinical trials. The guidance on the management of clinical trials during COVID-19 pandemic provided a set of recommendations that included adjustments to the informed consent process, the distribution of IMPs and in monitoring under specific circumstances. This guidance is specific to the COVID-19 health crisis in the European Union (EU)/European Economic Area (EEA) and is intended to be revoked when there is a consensus that the period of the COVID-19 outbreak in the EU/EEA has passed. The above context and trend highlight the need to provide further recommendations on the introduction of decentralised elements in the conduct of clinical trials in the EU/EEA, regardless of any health crisis, and in consideration of the currently limited national guidelines. The aim of this recommendation paper is to address this requirement. The intention is to facilitate the use of decentralised elements in clinical trials in the EU/EEA. However, the necessary level of trial participant’s safety, protection of their rights and dignity should be ensured. In addition, the reliability of data for publication and submission for regulatory decision-making should be guaranteed.

You can read the full guidance here.

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