Protect first-to-human studies

The so-called intervention (drug) studies are divided into four phases, with the “first person” or phase I as the beginning, with the aim of testing initial safety and tolerability as well as medicinal values measure medicine. “First-in-human” studies are usually only conducted with a small population of up to a dozen subjects. The term already means that the drug is being tested on humans for the first time, usually on healthy volunteers, to determine the potential risks of the next development cycle. reduce This causes more health risks for the participating test subjects, so that obtaining clinical studies and participating test subjects is an essential part of the approval process for the ethics committees. Therefore the so-called test person insurance is required according to regulation. If, despite the careful planning of the investigation, there is still damage to the life and limb of the affected people, the sponsor must at least provide adequate compensation for this. It was only after the unfortunate incident in a study by TeGenero AG in 2016 that changes were made to the design of the study structure. Since then, serial administration has been established to identify side effects more quickly and thus prevent future occurrences more quickly. In addition to the specific risk of the active ingredient, ethics committees hold the sponsor more responsible for the duty of care, including when it comes to the safety of the test subjects on the way to the research center and back. Supplementary “travel accident” insurance covers the effects of ill health that occur on the direct route to or from the examination center, even if the sponsor is not at fault.

The risk statement by Jutta Zaglauer (Senior Risk Advisor – Life Sciences, Risk Partners GmbH) is a case 3/2024 by | transcription removed.