EMA revises guidelines for first-in-human studies
To facilitate matters for actors and reduce the risks for participants in clinical studies, the European Medicines Agency (EMA) has revised its guidelines for first-in-human studies.
Through the revision of the “Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products”, the existing EU guidelines for early clinical trials have now been extended. The aim of the revision is to facilitate the transfer between the pre-clinical and clinical phases. The document deals with issues such as quality aspects, study design, dose calculation and implementation.
The revision comes into force on 1 February 2018.