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{{Resource | {{Resource | ||
|Resource Type=Cases | |Resource Type=Cases | ||
| − | |Title= | + | |Title=A Review of the Impact of the TeGenero Trial on the Design, Conduct, and Ethics of FIM Trials |
| − | |Is About=This | + | |Is About=This factual case details a so-called ‘First-in-man’ (FIM) clinical trial that seriously harmed the six participants who received the drug under investigation. The report discusses the consequences of the disastrous trial for later FIM trials. The article considers the scientific consequences, such as the procedure to determine the acceptable dose of the drug, and reviews the ethical dimensions of FIM trials, like potential monetary compensation for the risks the participants take. |
| − | |Important Because= | + | <references /> |
| − | + | |Important Because=The health of the participants should be the top priority in clinical trials, especially in 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 the utmost importance to review the errors made and learn lessons from tragic cases such as the one discussed here. The overview presented by the current article may help us to do so. | |
| − | + | <references /> | |
| − | + | |Important For=Researchers; Research Ethics Committees | |
| − | |||
| − | |||
| − | |Important For=Researchers | ||
}} | }} | ||
{{Link | {{Link | ||
|Has Link=https://journals.lww.com/americantherapeutics/Abstract/2007/11000/First_in_Man__FIM__Clinical_Trials_Post_TeGenero_.20.aspx | |Has Link=https://journals.lww.com/americantherapeutics/Abstract/2007/11000/First_in_Man__FIM__Clinical_Trials_Post_TeGenero_.20.aspx | ||
}} | }} | ||
| − | {{Related To}} | + | {{Related To |
| + | |Related To Theme=Theme:0d054575-ca21-4209-b7c5-6120fc0ed647;Theme:E5629f68-81f6-490d-84d6-fd1e63b8dbc7;Theme:D44fd22a-ed5d-4120-a78b-8881747131fd | ||
| + | }} | ||
{{Tags | {{Tags | ||
|Has Timepoint=2006 | |Has Timepoint=2006 | ||
|Has Location=England | |Has Location=England | ||
| − | |Has Virtue And Value=Respect | + | |Has Virtue And Value=Respect; Integrity; Autonomy; Compassion; Dignity |
| − | |Has Good Practice And Misconduct=Patient safety; Informed consent; Experimental design | + | |Has Good Practice And Misconduct=Patient safety; Informed consent; Experimental design; Clinical trials |
|Related To Research Area=Clinical medicine | |Related To Research Area=Clinical medicine | ||
}} | }} | ||
Latest revision as of 16:06, 19 August 2021
ResourcesCases
A 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 who received the drug under investigation. The report discusses the consequences of the disastrous trial for later FIM trials. The article considers the scientific consequences, such as the procedure to determine the acceptable dose of the drug, and 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 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 the utmost importance to review the errors made and learn lessons from tragic cases such as the one discussed here. The overview presented by the current article may help us to do so.
