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肾脏病临床研究的全球能力:国际肾脏病学会的一项调查

Global capacity for clinical research in nephrology: a survey by the International Society of Nephrology.

作者信息

Okpechi Ikechi G, Alrukhaimi Mona, Ashuntantang Gloria E, Bellorin-Font Ezequiel, Benghanem Gharbi Mohammed, Braam Branko, Feehally John, Harris David C, Jha Vivekanand, Jindal Kailash, Johnson David W, Kalantar-Zadeh Kamyar, Kazancioglu Rumeyza, Levin Adeera, Lunney Meaghan, Olanrewaju Timothy Olusegun, Perkovic Vlado, Perl Jeffrey, Rashid Harun Ur, Rondeau Eric, Salako Babatunde Lawal, Samimi Arian, Sola Laura, Tchokhonelidze Irma, Wiebe Natasha, Yang Chih-Wei, Ye Feng, Zemchenkov Alexander, Zhao Ming-Hui, Bello Aminu K

机构信息

Division of Nephrology and Hypertension, University of Cape Town, Cape Town, South Africa.

Kidney and Hypertension Research Unit, University of Cape Town, Cape Town, South Africa.

出版信息

Kidney Int Suppl (2011). 2018 Feb;8(2):82-89. doi: 10.1016/j.kisu.2017.10.012. Epub 2018 Jan 19.

Abstract

Due to the worldwide rising prevalence of chronic kidney disease (CKD), there is a need to develop strategies through well-designed clinical studies to guide decision making and improve delivery of care to CKD patients. A cross-sectional survey was conducted based on the International Society of Nephrology Global Kidney Health Atlas data. For this study, the survey assessed the capacity of various countries and world regions in participating in and conducting kidney research. Availability of national funding for clinical trials was low (27%,  = 31), with the lowest figures obtained from Africa (7%,  = 2) and South Asia (0%), whereas high-income countries in North America and Europe had the highest participation in clinical trials. Overall, formal training to conduct clinical trials was inadequate for physicians (46%,  = 53) and even lower for nonphysicians, research assistants, and associates in clinical trials (34%,  = 39). There was also diminished availability of workforce and funding to conduct observational cohort studies in nephrology, and participation in highly specialized transplant trials was low in many regions. Overall, the availability of infrastructure (bio-banking and facilities for storage of clinical trial medications) was low, and it was lowest in low-income and lower-middle-income countries. Ethics approval for study conduct was mandatory in 91% ( = 106) of countries and regions, and 62% ( = 66) were reported to have institutional committees. Challenges with obtaining timely approval for a study were reported in 53% ( = 61) of regions but the challenges were similar across these regions. A potential limitation is the possibility of over-reporting or under-reporting due to social desirability bias. This study highlights some of the major challenges for participating in and conducting kidney research and offers suggestions for improving global kidney research.

摘要

由于全球慢性肾脏病(CKD)患病率不断上升,有必要通过精心设计的临床研究制定策略,以指导决策并改善对CKD患者的护理。基于国际肾脏病学会全球肾脏健康地图集数据进行了一项横断面调查。在本研究中,该调查评估了各个国家和世界区域参与和开展肾脏研究的能力。各国临床试验的国家资金可用性较低(27%,n = 31),其中非洲(7%,n = 2)和南亚(0%)的比例最低,而北美和欧洲的高收入国家参与临床试验的比例最高。总体而言,医生进行临床试验的正规培训不足(46%,n = 53),对于非医生、临床试验研究助理和相关人员而言甚至更低(34%,n = 39)。肾脏病学领域进行观察性队列研究的劳动力和资金可用性也有所减少,许多地区参与高度专业化移植试验的比例较低。总体而言,基础设施(生物样本库和临床试验药物储存设施)的可用性较低,在低收入和中低收入国家最低。91%(n = 106)的国家和地区进行研究需要伦理批准,据报告62%(n = 66)设有机构委员会。53%(n = 61)的地区报告了在及时获得研究批准方面存在挑战,但这些地区的挑战类似。一个潜在的局限性是由于社会期望偏差可能存在报告过度或不足的情况。本研究突出了参与和开展肾脏研究的一些主要挑战,并为改善全球肾脏研究提供了建议。

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本文引用的文献

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Global Kidney Health Atlas (GKHA): design and methods.全球肾脏健康地图集(GKHA):设计与方法
Kidney Int Suppl (2011). 2017 Oct;7(2):145-153. doi: 10.1016/j.kisu.2017.08.001. Epub 2017 Sep 20.
3
Assessment of Global Kidney Health Care Status.全球肾脏健康护理状况评估。
JAMA. 2017 May 9;317(18):1864-1881. doi: 10.1001/jama.2017.4046.
7
10
The wealth of nations and the dissemination of cardiovascular research.国家财富与心血管研究的传播。
Int J Cardiol. 2013 Nov 5;169(3):190-5. doi: 10.1016/j.ijcard.2013.08.101. Epub 2013 Sep 10.

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