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使用专家替代指标评估非小细胞肺癌临床试验

The use of expert surrogates to evaluate clinical trials in non-small cell lung cancer.

作者信息

Mackillop W J, Ward G K, O'Sullivan B

出版信息

Br J Cancer. 1986 Oct;54(4):661-7. doi: 10.1038/bjc.1986.224.

DOI:10.1038/bjc.1986.224
PMID:3022780
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2001499/
Abstract

One hundred and eighteen doctors who treat pulmonary neoplasms in Ontario were asked how they would wish to be treated if they had non-small cell lung cancer. Four different scenarios were given. The physicians were then asked if they would consent to take part as subjects in one or more clinical trials for which they would be eligible in those situations. The proportion of respondents who would consent to each study ranged from 11% to 64%. Reasons given for refusing to participate as subjects in each trial were varied, but many felt that the trials offered unacceptable options for treatment. Medical oncologists consented to each study more frequently than radiation oncologists, respirologists or thoracic surgeons but all disciplines ranked the 6 studies in the same order of acceptability. It is concluded that some patients with non-oat cell lung cancer currently receive experimental therapies with high risk/benefits ratios which experts in the field would not accept for themselves. It is suggested that the expert surrogate system may be useful as an adjunct to the institutional review board in evaluating new trials before they are activated.

摘要

安大略省118名治疗肺部肿瘤的医生被问及,如果他们患有非小细胞肺癌,希望得到怎样的治疗。给出了四种不同的情况。然后还询问这些医生是否会同意在这些情况下参与一项或多项适合他们的临床试验。愿意参与每项研究的受访者比例在11%至64%之间。拒绝参与每项试验的原因各不相同,但许多人认为这些试验提供的治疗选择不可接受。与放射肿瘤学家、呼吸科医生或胸外科医生相比,肿瘤内科医生更频繁地同意参与每项研究,但所有学科对这6项研究的可接受程度排序相同。得出的结论是,目前一些非燕麦细胞肺癌患者接受的实验性治疗具有高风险/效益比,而该领域的专家自己不会接受这些治疗。建议专家替代系统在评估新试验启动前,作为机构审查委员会的辅助手段可能会很有用。