The EU Commission released a recommendation paper on decentralized elements in clinical trials in late 2022. The document addresses the increasing complexity of study design and the use of technological tools, which have resulted in certain trial activities and assessments being conducted outside of the clinical site. The guidelines provided in the document aim to assist sponsors and investigators in managing these decentralized trials, while ensuring patient safety and data reliability. The paper covers various aspects of decentralized trials, including sponsor and investigator oversight, electronic informed consent, delivery of investigational medicinal products (IMPs), study-related home procedures, and data management and monitoring.
The guidelines also discuss electronic informed consent, allowing for remote consent interviews and various methods of signing the informed consent form, such as manual or electronic signatures. Additionally, the guidelines emphasize the importance of maintaining quality standards for data collection and study procedures when conducting assessments at the patient's home.
This PQE article aims to discuss the impact of this recommendation paper while also highlighting the growing importance of decentralized trials and the need for high-quality standards in their development and management.