A Review of the Impact of the TeGenero Trial on the Design, Conduct, and Ethics of FIM Trials
ResourcesA Review of the Impact of the TeGenero Trial on the Design, Conduct, and Ethics of FIM Trials
What is this about?
This factual case details a so-called ‘’First-in-man’ (FIM) clinical trial that seriously harmed the six participants that received the drug under investigation. The report discusses the consequences of the disastrous trial for later FIM trials. The article first considers the scientific consequences, such as the procedure to determine the acceptable dose of the examined drug. Furthermore, the article reviews the ethical dimensions of FIM trials, like potential monetary compensation for the risks the participants take.
Why is this important?
The health of the participants should be the top priority in clinical trials, especially in the FIM trials, where drugs are tested that potentially pose a high risk to the health of the participants. The case discussed here shows that even when the trial is reviewed and approved by ethical boards, it can end disastrously for the trial participants. Therefore, it is of utmost importance to review the errors made and take lessons out of tragic cases such as the one discussed here. The overview presented by the current article may help us to do so.
