法国成人肿瘤早期临床试验:生物伦理学初步实证研究。

IF 4.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL European Journal of Clinical Investigation Pub Date : 2024-09-05 DOI:10.1111/eci.14315
Henri-Corto Stoeklé, Philippe Beuzeboc, Tara Payet, Christian Hervé, Jaafar Bennouna
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引用次数: 0

摘要

过去几年中,被称为 "靶向疗法 "和 "新免疫疗法 "1 的创新性新分子不断涌现,改善了癌症的治疗效果。其中一些疗法已经改善了对某些类型和亚型癌症的治疗效果。2 然而,除了通过临床试验,尤其是早期阶段的临床试验,患者仍然无法获得这些分子中不可忽视的一部分。我们在法国全国范围内开展了一项初步的生物伦理实证工作,在非系统性文献综述的基础上,制定了具体的方案4 ,以解决 "宏观生物伦理问题"。HCS、PB、CH 和 JB 是主要研究人员。他们参与了论文的构思、章节的起草以及关于如何完善和整合不同章节的讨论。HCS、TP和CH在提交的工作中没有利益冲突需要声明。PB从安斯泰来公司(教育会议)和辉瑞公司(参加ASCO 2023的差旅费)获得了个人酬金,所有这些酬金均未用于所提交的工作。JB 从 AstraZeneca、Bristol-Myers Squibb、MSD、Janssen Cilag、Daiichi 和 Sanofi Aventis(咨询委员会、教育研讨会和酬金)处获得个人酬金,所有这些酬金均未用于所提交的工作。
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Early-phase clinical trials in oncology for adults in France: A preliminary empirical bioethics study

The last few years have seen the improvement of cancer management through the arrival of a continuous stream of innovative new molecules known as ‘targeted therapies’ and ‘new immunotherapies’.1 One characteristic common to all these treatments is a specific link to a precise cellular and/or molecular profile. Some of these treatments are already improving therapeutic results for certain types and subtypes of cancer.2 However, a non-negligible proportion of these molecules remain inaccessible to patients other than through clinical trials, particularly early-phase clinical trials.3 The aims of such clinical trials were initially limited to identifying toxicities associated with the molecules tested, but they now extend to the evaluation of efficacy and possible therapeutic benefits for participants. We performed a preliminary empirical bioethics work at national scale in France, with specific protocolization,4 based on a non-systematic literature review, to deal with the ‘macro-bio-ethical issues’.

HCS, PB, CH and JB are the principal investigators. They contributed to the conception of the paper, the drafting of sections and discussions about how the different sections should be refined and integrated. TP is an undergraduate trainee who helped collect and process the data.

Foch Hospital.

HCS, TP and CH have no conflicts of interest to declare for the submitted work. PB has received personal fees from Astellas (educational sessions) and Pfizer (travel expenses to ASCO 2023), all outside of the submitted work. JB has received personal fees from AstraZeneca, Bristol-Myers Squibb, MSD, Janssen Cilag, Daiichi and Sanofi Aventis (advisory board, educational symposium and honorarium), all outside of the submitted work.

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来源期刊
CiteScore
9.50
自引率
3.60%
发文量
192
审稿时长
1 months
期刊介绍: EJCI considers any original contribution from the most sophisticated basic molecular sciences to applied clinical and translational research and evidence-based medicine across a broad range of subspecialties. The EJCI publishes reports of high-quality research that pertain to the genetic, molecular, cellular, or physiological basis of human biology and disease, as well as research that addresses prevalence, diagnosis, course, treatment, and prevention of disease. We are primarily interested in studies directly pertinent to humans, but submission of robust in vitro and animal work is also encouraged. Interdisciplinary work and research using innovative methods and combinations of laboratory, clinical, and epidemiological methodologies and techniques is of great interest to the journal. Several categories of manuscripts (for detailed description see below) are considered: editorials, original articles (also including randomized clinical trials, systematic reviews and meta-analyses), reviews (narrative reviews), opinion articles (including debates, perspectives and commentaries); and letters to the Editor.
期刊最新文献
Issue Information [225Ac]Ac-PSMA for the treatment of metastatic castration-resistant prostate cancer: A systematic review and meta-analysis. Machine learning for stroke in heart failure with reduced ejection fraction but without atrial fibrillation: A post-hoc analysis of the WARCEF trial. Structural aspects of CEACAM1 interactions. Clinical measures in chronic neuropathic pain are related to the Kennedy and endocannabinoid pathways.
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