由行业资助的药物试验更可能公布有利的结果

在综合研究结果报告的水龙头

2010年8月3日
波士顿，大众。-当公布的结果有系统地跟踪药物试验登记临床试验从产业资助的试验，这是最有可能有利于问题的药物，研究人员报告在波士顿儿童医院。出版业8月3日发行在内科年鉴，研究人员呼吁更多的公开披露有关临床药物试验，在他们的一开始，以减少偏见的可能性的结果。

研究小组，领导佛罗伦萨资产阶级，MD，MPH，儿童急诊医学科，和Kenneth Mandl，MD，MPH，实验室主任儿童医院信息学计划, reviewed 546 drug trials conducted between 2000 and 2006 and listed with 临床试验, a comprehensive, web-based federal registry of clinical trials。 The analysis focused on five classes of drugs: cholesterol-lowering drugs, antidepressants, antipsychotics, proton-pump inhibitors and vasodilators。 The researchers scanned the medical literature for publications associated with each trial, checking four separate databases and contacting trial investigators directly if necessary。

Overall, allowing for a three-year lag time from the completion 在 trial, two-thirds 在 trials had published results。 The industry-funded trials reported positive outcomes 85 percent 在 time, as compared with 50 percent for government-funded trials and 72 percent for trials funded by nonprofits or non-federal organizations。 In addition, among the nonprofit/nonfederal trials, those that had industry contributions (nearly half) were more likely than those without to report positive outcomes (85 vs。 61 percent)。 These differences were all statistically significant。

The researchers acknowledge that the pharmaceutical industry was probably more selective in which trials it funded, helping to account for their greater proportion of favorable outcomes。 "Industry is very good at knowing what they want to study，和 industry-sponsored studies are more efficient and well funded," says Bourgeois, the study's first author。 "But despite these potential biases, this is a stunning result。"

产业资助的试验是在研究更先进的阶段；百分之89阶段3或4阶段，而不只是政府资助的试验和非营利\/ nonfederally资助的试验百分之65百分之51。然而，即使是1期和2期试验资助的研究报告的比例最高的有利结果。

In addition, industry-funded trials were the least likely to have published results within two years of study completion (32 percent) as compared with trials with no industry contributions (54 percent for government trials，和 56 percent for purely nonprofit/nonfederal trials)。

正如研究人员所讨论的，临床试验可以以各种方式进行操作，使结果显得更为有利。发表偏倚-有选择地发表的倾向，只有积极的结果的一个试验，或延迟发表的负面结果-是一个因素，已得到了很大的关注，如在一个众所周知的2008研究抗抑郁药新英国医学杂志。

"While we cannot specifically point to which factors contribute to the association between funding source and positive result reporting, our findings speak to the need for more disclosure of all elements of a study," says Bourgeois。 "Publication bias is likely a contributing factor, but there may be many more, including biases in study design, patient selection, data analysis and results reporting。"

The use of registries like 临床试验, launched in 1999, was hoped to reduce publication bias by creating a record for all clinical trials。 In addition, in 2005, the国际医学杂志编辑委员会began requiring that a trial be registered before enrolling patients in order to be considered for publication, thus creating a record 在 planned study outcomes before the study's initiation。 In 2007, the FDA expanded the scope of Clinical Trials。gov, requiring the sponsors of all drug, biologic and device trials to register their studies upon launch (phase I trials excepted)。

If trial protocols are made public in advance, a trial sponsor is less able to manipulate or selectively publish the findings, the researchers argue。 "Our main call is for transparency, to enable better understanding 在 impact of funding source on the study outcomes，和 for all study results - good or bad - to be made available," says Mandl, the study's senior investigator, also an Associate Professor at Harvard Medical School。

这项研究是由国家医学图书馆和国家儿童健康与人类发展研究所。

接触：
克里斯特德曼
617-919-3110
keri。stedman@childrens。harvard。edu

波士顿儿童医院 is home to the world's largest research enterprise based at a pediatric medical center, where its discoveries have benefited both children and adults since 1869。 More than 1,100 scientists, including nine members 在 National Academy of Sciences, 12 members 在 Institute of Medicine and 13 members 在 Howard Hughes Medical Institute comprise Children's research community。 Founded as a 20-bed hospital for children, 波士顿儿童医院 today is a 392-bed comprehensive center for pediatric and adolescent health care grounded in the values of excellence in patient care and sensitivity to the complex needs and diversity of children and families。 Children's also is the primary pediatric teaching affiliate of Harvard Medical School。 For more information about the hospital and its research visit:www。childrenshospital。org/newsroom。

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