全球肾脏病临床研究能力:国际肾脏病学会的调查

IF 19.3 2区 医学 Q1 UROLOGY & NEPHROLOGY
Ikechi G. Okpechi , Mona Alrukhaimi , Gloria E. Ashuntantang , Ezequiel Bellorin-Font , Mohammed Benghanem Gharbi , Branko Braam , John Feehally , David C. Harris , Vivekanand Jha , Kailash Jindal , David W. Johnson , Kamyar Kalantar-Zadeh , Rumeyza Kazancioglu , Adeera Levin , Meaghan Lunney , Timothy Olusegun Olanrewaju , Vlado Perkovic , Jeffrey Perl , Harun Ur Rashid , Eric Rondeau , Aminu K. Bello
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引用次数: 10

摘要

由于慢性肾脏疾病(CKD)在世界范围内的患病率不断上升,有必要通过精心设计的临床研究来制定策略,以指导决策并改善对CKD患者的护理。根据国际肾脏病学会全球肾脏健康地图集数据进行了横断面调查。在这项研究中,调查评估了各个国家和世界地区参与和进行肾脏研究的能力。临床试验的国家资金可获得性较低(27%,n = 31),非洲(7%,n = 2)和南亚(0%)的数据最低,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),非医生、研究助理和临床试验助理的培训不足(34%,n = 39)。在肾脏学中进行观察性队列研究的劳动力和资金也在减少,而且在许多地区,高度专业化的移植试验的参与率很低。总体而言,基础设施(生物银行和临床试验药物储存设施)的可用性较低,低收入和中低收入国家的可用性最低。91% (n = 106)的国家和地区对研究行为的伦理批准是强制性的,62% (n = 66)的国家和地区报告有机构委员会。53% (n = 61)的地区报告了及时获得研究批准的挑战,但这些地区的挑战相似。一个潜在的限制是由于社会可取性偏见而导致报告过高或过低的可能性。本研究强调了参与和进行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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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

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

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

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%, n = 31), with the lowest figures obtained from Africa (7%, n = 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%, n = 53) and even lower for nonphysicians, research assistants, and associates in clinical trials (34%, n = 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% (n = 106) of countries and regions, and 62% (n = 66) were reported to have institutional committees. Challenges with obtaining timely approval for a study were reported in 53% (n = 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.

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来源期刊
Kidney International Supplements
Kidney International Supplements UROLOGY & NEPHROLOGY-
CiteScore
11.80
自引率
0.00%
发文量
13
期刊介绍: Kidney International Supplements is published on behalf of the International Society of Nephrology (ISN) and comes complimentary as part of a subscription to Kidney International. Kidney International Supplements is a peer-reviewed journal whose focus is sponsored, topical content of interest to the nephrology community.
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