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

Landscape of cancer clinical trials in Australia: using trial registries to guide future research
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DOI:
10.5694/j.1326-5377.2011.tb03027.x
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发表时间:
2011-04-18
影响因子:
11.4
通讯作者:
Tattersall, Martin H. N.
Tattersall, Martin H. N.
中科院分区:
医学2区
文献类型:
--
作者:
Dear, Rachel F.;Barratt, Alexandra L.;Tattersall, Martin H. N.

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目的:量化和描述澳大利亚目前的癌症临床试验活动,并利用试验登记帮助指导未来的试验研究。设计和地点:从澳大利亚新西兰临床试验注册和ClinicalTrials.gov中摘录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行业赞助相关的因素。主要结果指标:癌症试验的比例与每个癌症患者估计的疾病负担的比较。结果:共有368项介入癌症试验公开招募。研究最多的癌症是乳腺癌,占试验的17%。只有7%的试验涉及肺癌,然而肺癌是最大的疾病负担。在43%的试验中,工业是主要赞助商。药物治疗在大多数试验中进行了测试(69%)。如果试验测试的是全身治疗而不是局部治疗(OR,16.71;95%CI,4.70-59.43),包括晚期而不是早期疾病的患者(OR,3.76;95%CI,1.78-7.94),使用随机分配而不是非随机分配(OR,1.78;95%CI,1.06-3.00),则试验更有可能得到行业赞助。结论:根据癌症部位的不同,试验数量存在差异,某些癌症相对于其疾病负担而言代表不足。对于研究系统疗法、招募晚期疾病患者并随机进行的试验,更有可能获得行业赞助。《MJA 2011》;194:387-391
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% Cl, 4.70-59.43), included patients with advanced rather than early disease (OR, 3.76; 95% Cl, 1.78-7.94) and used random rather than non-random allocation (OR, 1.78; 95% Cl, 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. MJA 2011; 194: 387-391