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志愿者还是受害者:患者对癌症随机临床试验的看法

Volunteers or victims: patients' views of randomised cancer clinical trials.

作者信息

Slevin M, Mossman J, Bowling A, Leonard R, Steward W, Harper P, McIllmurray M, Thatcher N

机构信息

Department of Medical Oncology, St Bartholomew's Hospital, West Smithfield, London, UK.

出版信息

Br J Cancer. 1995 Jun;71(6):1270-4. doi: 10.1038/bjc.1995.245.

Abstract

Randomised clinical trials are essential for the objective evaluation of different treatment strategies in cancer. However, in the field of oncology, very few of the eligible patients are entered into trials, and most treatments have only been tested on a small percentage of patients. For doctors, a major deterrent to participating in trials is the lack of resources--particularly time, but often also the local facilities. This report suggests that patients themselves are willing to take part in clinical research, and are attracted by being treated by a doctor with a specialist interest in the disease and encouraged by the possibility that their progress will be monitored closely. With the recent NHS changes, it is timely for the Department of Health and other national health departments to consider carefully what can be done to ensure that no new treatments are adopted without effective evaluation. This will require departments of health to identify and implement ways to facilitate accrual of appropriate numbers of patients onto research protocols (whether non-randomised phase I or phase II studies or large, multicentre phase III trials) over short time periods.

摘要

随机临床试验对于客观评估癌症的不同治疗策略至关重要。然而,在肿瘤学领域,符合条件的患者中很少有人参与试验,而且大多数治疗方法仅在一小部分患者身上进行过测试。对于医生而言,参与试验的一个主要障碍是资源匮乏——尤其是时间,但通常当地设施也不足。本报告表明,患者自身愿意参与临床研究,并且受到对该疾病有专业兴趣的医生治疗的吸引,同时也因自身病情进展将得到密切监测的可能性而受到鼓舞。随着英国国民医疗服务体系(NHS)近期的变革,卫生部和其他国家卫生部门应及时认真考虑如何确保在没有有效评估的情况下不采用新的治疗方法。这将要求卫生部门确定并实施相关方法,以便在短时间内促使适当数量的患者加入研究方案(无论是非随机的I期或II期研究,还是大型多中心III期试验)。

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Patient perceptions concerning clinical trials in oncology patients.肿瘤患者对临床试验的看法。
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本文引用的文献

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New approach for recruitment into randomised controlled trials.随机对照试验招募的新方法。
Lancet. 1993 Mar 27;341(8848):812-3. doi: 10.1016/0140-6736(93)90573-y.
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Informed consent -- why are its goals imperfectly realized?知情同意——为何其目标未能完全实现?
N Engl J Med. 1980 Apr 17;302(16):896-900. doi: 10.1056/NEJM198004173021605.
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J Clin Oncol. 1984 Jul;2(7):849-55. doi: 10.1200/JCO.1984.2.7.849.
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Patients' preferences in randomized clinical trials.随机临床试验中患者的偏好
N Engl J Med. 1984 May 24;310(21):1385-7. doi: 10.1056/NEJM198405243102111.
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Selection bias in clinical trials.临床试验中的选择偏倚。
J Clin Oncol. 1985 Aug;3(8):1142-7. doi: 10.1200/JCO.1985.3.8.1142.

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