First-in-human Clinical Trials – FIH CTs (Part I)
- 12 April 2017
- 3Rs, early clinical trials, FIH, first-in-human, IMP, integrated protocols, investigational medicinal product, phase I, reduction, refinement, replacement, risk mitigation,
Clinical trials are essential for the development of medicines and without them patients cannot gain access to new potentially life-saving medicines. EU and international guidelines are in place to ensure that first-in-human clinical trials are conducted as safely as possible. EMA’s existing guideline, released in 2007, provides advice on first-in-human clinical trials, in particular on