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帕金森病的疾病修饰治疗试验:如何平衡患者、医生和行业合作伙伴的期望与利益?

Disease modifying treatment trials in Parkinson's disease: how to balance expectations and interests of patients, physicians and industry partners?

作者信息

Berg D, Eggert K, Haslinger B, Kassubek J, Mollenhauer B, Reetz K, Rogge A, Schaeffer E, Tönges L, Zeuner K E

机构信息

Department of Neurology, Christian-Albrecht University of Kiel, Arnold-Heller-Straße 3, 24105 Kiel, Germany.

Department of Neurology, Philipps-University of Marburg, Marburg, Germany.

出版信息

Neurol Res Pract. 2020 Nov 2;2:31. doi: 10.1186/s42466-020-00076-y. eCollection 2020.

Abstract

BACKGROUND

The advent of therapeutic strategies designed to modify the disease course in Parkinson's disease has raised great expectations in the currently conducted clinical trials. However, we see ethical challenges in the cooperation of industry and clinical partners, specifically evident in the way recruitment is performed.We here discuss the different positions and challenges of all involved to set the stage for a study and recruitment culture taking into account the expectations of all: (i) patients and their caregivers, ready to take the considerable burden of clinical trials in hope for the development of disease-modifying treatments; (ii) physicians and study nurses, obligated to the patients' well-being and benefit who accompany and supervise patients closely as basis for the performance of elaborate clinical trials (iii) industrial partners, investing years of efforts and finances to develop new treatments.

CONCLUSIONS

We conclude that the current competitive race for enrollment in clinical studies in PD is challenging the primary goal to ensure patients' benefit and formulate requests to the industrial partners to encounter these concerns.

摘要

背景

旨在改变帕金森病病程的治疗策略的出现,在当前正在进行的临床试验中引发了极大的期望。然而,我们看到行业与临床合作伙伴的合作存在伦理挑战,这在招募方式上尤为明显。我们在此讨论所有相关方的不同立场和挑战,以便为一种考虑到各方期望的研究和招募文化奠定基础:(i)患者及其护理人员,愿意承担临床试验的巨大负担,以期开发出改变疾病进程的治疗方法;(ii)医生和研究护士,对患者的福祉和利益负有责任,他们密切陪伴和监督患者,这是进行精细临床试验的基础;(iii)行业合作伙伴,投入多年的努力和资金来开发新的治疗方法。

结论

我们得出结论,目前帕金森病临床研究招募中的竞争正在挑战确保患者受益的首要目标,并向行业合作伙伴提出要求以应对这些问题。

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