Aims

Most randomised controlled trials (RCTs) in oncology are now funded by the pharmaceutical industry. We explore the extent to which RCT design, results and interpretation differ between industry-funded and non-industry-funded RCTs.

Materials and methods

In this cross-sectional analysis, a structured literature search was used to identify all oncology RCTs published globally during 2014–2017. Industry funding was identified based on explicit statements in the publication. Descriptive statistics were used to compare elements of trial methodology and output between industry- and non-industry-funded RCTs.

Results

The study sample included 694 RCTs; 71% were funded by industry. Industry-funded trials were more likely to test systemic therapy (97% versus 62%; P < 0.001), palliative-intent therapy (71% versus 41%; P < 0.001) and study breast cancer (20% versus 12%; P < 0.001). Industry-funded trials were larger (median sample size 474 versus 375; P < 0.001) and more likely to meet their primary end point (49% versus 41%; P < 0.001). Among positive trials, there were no differences in the magnitude of benefit between industry- and non-industry-funded RCTs. Trials funded by industry were published in journals that had a significantly higher median impact factor (21, interquartile range 7, 28) than non-industry-funded trials (impact factor 12, interquartile range 5, 24; P = 0.005); this persisted when adjusted for whether a trial was positive or negative.

Conclusions

The vast majority of oncology RCTs are now funded by industry. Industry-funded trials are larger, more likely to be positive, predominantly test systemic therapies in the palliative setting and are published in higher impact journals than trials without industry support.

中文翻译：

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肿瘤学随机对照试验的行业资助：对设计、结果和解释的影响

目标

大多数肿瘤学随机对照试验 (RCT) 现在都由制药行业资助。我们探讨了行业资助和非行业资助的 RCT 之间的 RCT 设计、结果和解释的差异程度。

材料和方法

在这项横断面分析中，使用结构化文献检索来确定 2014-2017 年期间全球发表的所有肿瘤 RCT。行业资金是根据出版物中的明确声明确定的。描述性统计数据用于比较行业和非行业资助的 RCT 之间的试验方法和产出的要素。

结果

研究样本包括 694 项 RCT；71% 由行业资助。行业资助的试验更有可能测试全身治疗（97% 对 62%；P < 0.001）、姑息治疗（71% 对 41%；P < 0.001）和研究乳腺癌（20% 对 12%；P < 0.001)。行业资助的试验规模更大（中位样本量 474 对 375；P < 0.001）并且更有可能达到其主要终点（49% 对 41%；P< 0.001)。在阳性试验中，行业资助和非行业资助的 RCT 之间的获益幅度没有差异。由行业资助的试验发表在影响因子中位数（21，四分位距 7, 28）显着高于非行业资助试验（影响因子 12，四分位距 5, 24；P = 0.005）的期刊上；当根据试验是阳性还是阴性进行调整时，这种情况仍然存在。

结论

绝大多数肿瘤 RCT 现在由行业资助。与没有行业支持的试验相比，行业资助的试验规模更大，更有可能是阳性的，主要测试姑息治疗中的系统性疗法，并且发表在影响更大的期刊上。