Swiss authorities clarify safety rules for first-in-human trials

Swiss regulators have set out how trial sponsors should minimize the inherent risks of first-in-human (FIH) clinical studies in a new position paper.

Swissmedic, the Swiss Agency for Therapeutic Products, and swissethics, the Swiss Association of Research Ethics Committees, published the paper last week explaining the recommendations are based on ICH GCP E6.

“Trial participants are estimated to be at unforeseen risk of serious adverse events including potential emergency situations such as uncontrolled immune cascades, anaphylactic shock, or even cardiac arrest.

“With this position paper, Swissmedic and swissethics aim at highlighting several important points to consider in the management and practical conduct of FIH/early phase I trials,” the organizations said.

In the paper, Swissmedic and swissethics reiterate the importance of assessing the potential risks posed by the drug candidate before designing the study.

“The risk assessment should take into account the safety profile of the investigational medicinal product, the set-up of the trial, the population studied, the specific pharmacological dose regime and maybe further additional factors.”

They also urge caution when it comes to designing dose escalation profiles.

“The process of decision-making regarding the dose-escalation steps based on the data becoming available during the conduct of the trial has to be described precisely either in the protocol or a separate charter.”

Facilities

Swissmedic and swissethics also make clear that research facilities need to ensure they have appropriate expertise and systems in place to safeguard volunteers who take part in early phase drug research.

“Early Phase I clinical trials should be conducted by trained investigators and site staff, which are experienced in conducting early phase trials. This type of trial should take place under controlled conditions and in appropriate facilities preferable in specialized Phase I units.

They added that “procedures and systems that encompass high standards for avoiding harm to trial subjects and for handling medical emergencies need to be implemented.”

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