Controlled human infection trials: Legitimacy and conditions of implementation in France

IF 2.2 4区医学 Q3 PHARMACOLOGY & PHARMACY

Therapie Pub Date : 2024-01-01 DOI:10.1016/j.therap.2023.11.009

Anne-Laure Morin , Emmanuelle Blanc , Armelle Phalipon , Pierre-Henri Bertoye , Philippe Amiel , Cécile Artaud , Philippe Barthélemy , Elisabeth Botelho-Nevers , Soizic Courcier , Jean-Luc Cracowski , François Eisinger , Remi Forrat , Alina Gruber , Euzebiusz Jamrozik , Odile Launay , Claire Le Jeunne , David Simhon

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引用次数: 0

Abstract

This round table is the result of an observation. The observation being that controlled human infection clinical trials (also called “infectious challenge” trials or “Controlled Human Infection Models”, “CHIM”) recommended or even encouraged in the context of vaccine developments in particular, are not carried out in France. However, there are no formal prohibitions within regulations or ethical principles, which point to the prior assessment of risks and benefits for individuals and for society. The participants in this Round Table thus wished to examine, through the prism of their respective disciplines, the scientific and medical relevance of conducting such trials in France and, if possible, to imagine the conditions under which they would be carried out, thus resulting in recommendations on (1) the advisability of their conduct in France (2), the conditions under which they would be implemented in terms of logistics and regulations, and (3) their social acceptability. The recommendations on which the participants of the Round Table came to an agreement are presented as the analysis progresses.

查看原文本刊更多论文

控制性人体感染试验：法国实施的合法性和条件。

这次圆桌会议是一次观察的结果。在法国，尤其是在疫苗研发方面，建议甚至鼓励进行的控制性人体感染临床试验（也称为 "感染挑战 "试验或 "控制性人体感染模型"，"CHIM"）并未开展。然而，法规或伦理原则中并没有正式的禁止性规定，这就要求事先对个人和社会的风险和利益进行评估。因此，本次圆桌会议的与会者希望通过各自学科的棱镜，研究在法国进行此类试验的科学和医学意义，并在可能的情况下，设想进行试验的条件，从而就以下方面提出建议：(1) 在法国进行试验的可取性；(2) 在后勤和规章制度方面实施试验的条件；(3) 社会的可接受性。圆桌会议与会者达成一致意见的建议将在分析过程中介绍。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Therapie 医学-药学

CiteScore

3.50

自引率

7.70%

发文量

132

审稿时长

57 days

期刊介绍： Thérapie is a peer-reviewed journal devoted to Clinical Pharmacology, Therapeutics, Pharmacokinetics, Pharmacovigilance, Addictovigilance, Social Pharmacology, Pharmacoepidemiology, Pharmacoeconomics and Evidence-Based-Medicine. Thérapie publishes in French or in English original articles, general reviews, letters to the editor reporting original findings, correspondence relating to articles or letters published in the Journal, short articles, editorials on up-to-date topics, Pharmacovigilance or Addictovigilance reports that follow the French "guidelines" concerning good practice in pharmacovigilance publications. The journal also publishes thematic issues on topical subject. The journal is indexed in the main international data bases and notably in: Biosis Previews/Biological Abstracts, Embase/Excerpta Medica, Medline/Index Medicus, Science Citation Index.