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发展中世界肿瘤学临床试验开展中的障碍:肿瘤学家横断面调查

Barriers in conducting clinical trials in oncology in the developing world: A cross-sectional survey of oncologists.

作者信息

Dandekar M, Trivedi R, Irawati N, Prabhash K, Gupta S, Agarwal J P, D'Cruz A K

机构信息

Department of Head Neck Surgical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.

出版信息

Indian J Cancer. 2016 Jan-Mar;53(1):174-7. doi: 10.4103/0019-509X.180865.

Abstract

BACKGROUND

Several obstacles impede oncologists from performing clinical trials in the developing world. This study aimed to identify these barriers in order of importance and suggest possible remedial measures.

MATERIALS AND METHODS

Design - cross-sectional survey. Two part questionnaire capturing experience of oncologists in practice and conducting trials (Part 1) and perceived barriers pertaining to investigator (training, time), patient (strict follow-up protocol), infrastructure (funds) and professional environment (encouragement from seniors) (Part 2) were administered to oncologists in two different settings: (1) Online portal (Survey Monkey) (2) In person during a national conference (Best of American Society of Clinical Oncology). Responses were captured on a Likert scale (1-5).

RESULTS

(436/3021) 14.04% responded. A total of 313 (71.8%) had experience in conducting trials, but these were mainly industry-sponsored or small nonpractice changing studies. Lack of patient follow-up was the most significant barrier (inter quartile range [IQR] 4-5) followed by inadequate training, time and funds (IQR 2-5) and lack of encouragement (IQR 2-4) in decreasing order of frequency. Lack of adequate training was a barrier across all specialties (113 [71.97%] radiation oncologists, 71 [60.68%] medical oncologists and 73 [71.56%] surgical oncologists). More than half of the respondents without experience in clinical trials worked in academic institutions (50.48%). They perceived time constraint as a barrier more than their counterparts into private practice (175/242 [72.31%] vs. 119/177 [66.47%] respectively).

CONCLUSION

Inability to maintain patient follow-up, lack of protected time and funds, inadequate training were the most significant barriers. Most of these can be addressed.

摘要

背景

有几个障碍阻碍肿瘤学家在发展中世界开展临床试验。本研究旨在按重要性顺序确定这些障碍,并提出可能的补救措施。

材料与方法

设计——横断面调查。向处于两种不同环境下的肿瘤学家发放两部分问卷,第一部分问卷收集肿瘤学家的实践和开展试验的经验,第二部分问卷收集与研究者(培训、时间)、患者(严格的随访方案)、基础设施(资金)和专业环境(上级鼓励)相关的感知障碍:(1)在线平台(Survey Monkey);(2)在全国会议(美国临床肿瘤学会最佳会议)期间当面发放。采用李克特量表(1 - 5)收集回答。

结果

(436/3021)14.04%的人做出回应。共有313人(71.8%)有开展试验的经验,但这些试验主要是行业资助的或对实践改变不大的小型研究。缺乏患者随访是最主要的障碍(四分位间距[IQR]为4 - 5),其次是培训不足、时间和资金问题(IQR为2 - 5)以及缺乏鼓励(IQR为2 - 4),按出现频率从高到低排列。缺乏充分培训是所有专业的障碍(113名[71.97%]放射肿瘤学家、71名[60.68%]医学肿瘤学家和73名[71.56%]外科肿瘤学家)。超过一半没有临床试验经验的受访者在学术机构工作(50.48%)。他们比从事私人执业的同行更认为时间限制是一个障碍(分别为175/242 [72.31%]和119/177 [66.47%])。

结论

无法维持患者随访、缺乏受保护的时间和资金以及培训不足是最主要的障碍。其中大多数问题可以得到解决。

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