Decentralised Clinical Trials (DCT) are subject to the same industry sponsor and trial investigator responsibilities and regulations as for any “traditional” trial. However, regulators and industry players often voice concern about DCT methods and technologies in terms of good clinical practice, data collection and overall trial design. Even though DCTs are fairly mature, a lot was learned about DCTs during the COVID-19 pandemic. Following earlier guidelines by certain regulators and CRO associations, the Heads of Medicines Agencies, the European Commission, and the European Medicines Agency published on 13 December 2022 an EU-level guidance in the form of a joint recommendation paper on decentralized elements in clinical trials. The Guidance covers specific DCT items of the trial process such as patient recruitment, informed consent and electronic signatures, trial supplies and drug administration, patient monitoring and data collection.
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