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Procedures required of sponsors prior to embarking on clinical trials in humans

When embarking on a clinical trial of an investigational medicinal product (IMP) for the first time in humans, the risks associated with the administration of the compound must be identified and mitigated accordingly. This article outlines some of the guidance sponsors should consider when designing a first-in-human trial. The procedures in the UK for trials using higher risk compounds and MHRA accreditation of Phase 1 units is also discussed.