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澳大利亚癌症临床试验全景:利用试验注册机构指导未来研究。

Landscape of cancer clinical trials in Australia: using trial registries to guide future research.

机构信息

Centre for Medical Psychology and Evidence-based Decision-making, University of Sydney, Sydney, NSW.

出版信息

Med J Aust. 2011 Apr 18;194(8):387-91. doi: 10.5694/j.1326-5377.2011.tb03027.x.

Abstract

OBJECTIVE

To quantify and describe current cancer clinical trial activity in Australia and help guide future trials research using trial registries.

DESIGN AND SETTING

Data from cancer trials recruiting in Australia at 31 March 2009 were extracted from the Australian New Zealand Clinical Trials Registry and ClinicalTrials.gov. A regression model was used to identify factors associated with industry sponsorship.

MAIN OUTCOME MEASURES

The proportion of cancer trials compared with estimated burden of disease for each cancer.

RESULTS

There were 368 interventional cancer trials open to recruitment. The most-researched cancer was breast cancer, accounting for 17% of trials. Only 7% of trials were in lung cancer, yet lung cancer is responsible for the greatest burden of disease. Industry was the primary sponsor in 43% of trials. Drug treatments were tested in most trials (69%). Trials were more likely to be industry sponsored if they tested systemic rather than local treatments (OR, 16.71; 95% CI, 4.70-59.43), included patients with advanced rather than early disease (OR, 3.76; 95% CI, 1.78-7.94) and used random rather than non-random allocation (OR, 1.78; 95% CI, 1.06-3.00).

CONCLUSION

There is variation in the number of trials according to cancer site, with some cancers being underrepresented relative to their burden of disease. Industry sponsorship is more likely for trials that investigate systemic therapy, recruit patients with advanced disease and are randomised.

摘要

目的

利用试验注册库量化和描述澳大利亚当前癌症临床试验活动,并为未来试验研究提供指导。

设计与设置

从澳大利亚和新西兰临床试验注册库和 ClinicalTrials.gov 提取 2009 年 3 月 31 日在澳大利亚招募癌症试验的数据。使用回归模型确定与工业赞助相关的因素。

主要观察指标

每种癌症的临床试验比例与疾病负担的估计值进行比较。

结果

共有 368 项干预性癌症试验正在招募。研究最多的癌症是乳腺癌,占试验的 17%。只有 7%的试验是肺癌,但肺癌造成的疾病负担最大。工业是 43%试验的主要赞助商。药物治疗是大多数试验的测试内容(69%)。如果试验测试的是系统性而非局部治疗(OR,16.71;95%CI,4.70-59.43),包括晚期而非早期疾病患者(OR,3.76;95%CI,1.78-7.94)和使用随机而非非随机分配(OR,1.78;95%CI,1.06-3.00),则试验更有可能由工业赞助。

结论

根据癌症部位,试验数量存在差异,某些癌症相对于其疾病负担代表性不足。针对系统性治疗、招募晚期疾病患者和随机分组的试验更有可能获得工业赞助。

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