Revised guidelines on first in-human clinical trial

On 1st February 2018, after the review of the EMA (the European Medicines Agency) with the contribution of the European Commission and the representatives of the EU Member States through the EU Clinical Trials Facilitation Group (CTFG), the new guidelines on first-in-human clinical trials will enter into force. The in-human clinical trials represent a turning point in medical development. Medicines already tested in vitro and on animals will be administered to humans for the first time.

The guideline will be focused on the safeguard and on the right of information of the people who will undergo these trials.  In fact, even if this category of tests is always subject to a certain degree of uncertainty, the tester will be responsible for exhaustively illustrating the potential risks related to each step of the trial process and which solutions and responses will be available in case of necessity.

The need for a revised guidance originates from the complexity and heterogeneity of in-human clinical trials procedures that have been performed in the past years.

The guideline highlights three main elements that have to be evaluated in order to address and moderate threats for tests applicants, namely: the correct evaluation of the initial dose to be administered to humans, the successive dose increase and the parameter used to calculate the highest dosages. Further attention is given to the conditions that lead to an interruption of the trial and the measures to be taken in order to guarantee a safe stopping point of the test.

In conclusion, clinical trials have revealed themselves to be a fundamental tool for medical progress.  The publication of the guideline has the aim of guaranteeing that in-human trials are conducted as safely as possible.

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