Dandekar M, Trivedi R, Irawati N, Prabhash K, Gupta S, Agarwal J P, D'Cruz A K
Department of Head Neck Surgical Oncology, Tata Memorial Centre, Mumbai, Maharashtra, India.
Indian J Cancer. 2016 Jan-Mar;53(1):174-7. doi: 10.4103/0019-509X.180865.
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.
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).
(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).
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.
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。
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。
(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%])。
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。