In December 2022, the European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Recommendation paper on decentralised elements in clinical trials based on the experience gained from the COVID-19 pandemic which highlighted the importance and usefulness of digital tools and decentralised procedures in a healthcare setting and in clinical trials.
Clinical trials on Investigational Medicinal Products (IMPs) are increasingly 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. This recommendation paper aims to address 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.
Moreover, an overview of the current national provisions applicable in each Member State (MS) in relation to these topics is outlined in the appendix. Nevertheless, it is at the discretion of the MS involved in 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 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 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) for regulatory issues of general impact not related to a specific trial.
Given the rapid advances in the field of decentralised clinical trials, the paper is expected to evolve when new insights and experiences are gained.
Read the recommendation paper here!