Expert View: Understanding drug pharmacology is essential for increasing the safety of First-into-Human clinical trials

12 April 2016

In our weekly expert view piece, Michael Eddleston, professor of clinical toxicology and Lister Prize fellow in the Pharmacology, Toxicology and Therapeutics Unit at the University of Edinburgh, calls for improvements to the safety of clinical trials, following the tragic outcomes of the Bial clinical trial in January 2016, when five volunteers were hospitalized and one subsequently died.

"Public release of all study and pre-clinical data is required urgently so that lessons can be learnt for the benefit of future participants."

Drug development requires first-into-human (FIH) studies to gain initial information on tolerability, pharmacokinetics/dynamics, and basic elements of drug safety. Such study protocols are reviewed by investigators, national drug regulatory authorities (DRA), and ethics committees. Hundreds of FIH trials are performed in Europe annually with few severe adverse events (SAEs).

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