The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published Version 1.0 of the recommendation paper on decentralised elements in clinical trials . The 33 page document was adopted by the Accelerate Clinical Trials in the European Union (ACT EU) Steering Group in December 2022.
Clinical trials on Investigational Medicinal Products (IMPs) increasingly use procedures conducted outside the traditional ‘clinical trial site’, a concept usually referred to as decentralisation. There is also the increased use of digital tools in clinical trials.
The guidance on the management of clinical trials during COVID-19 pandemic provides a set of recommendations that include amendments 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 EU/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 aim of this recommendation paper is to address the requirement 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 due to the currently limited national guidance. 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.
The recommendation paper addresses the following:
- the roles and responsibilities of the sponsor and investigator
- electronic informed consent
- IMP delivery
- trial related procedures at home
- data management and monitoring in a decentralised clinical trial setting.
An overview of the current national provisions applicable in each Member State (MS) in relation to these topics is outlined in the appendix of the recommendation paper. It should be noted that the national provision appendix is for guidance purposes only as it is not feasible to give a complete overview of all scenarios to implement decentralised elements in a clinical trial. It is at the discretion of the MS involved during the assessment of a clinical trial whether the use of certain decentralised elements is acceptable in a specific clinical trial.
Sponsors are encouraged to seek scientific advice via the European Medicine Agency [EMA, scientific advice working party (SAWP)], or via national competent authorities [national or simultaneous national scientific advice (SNSA)] regarding the use of specific decentralised elements, especially on those decentralised elements where experience and the evidence of their impact may be limited. Sponsors may also request a consolidated opinion via the Clinical Trial Coordination Group (CTCG) on regulatory issues of general impact not related to a specific trial.
See further information from the European Medicines Agency on these recommendations.
Source: European Commission