Vedula S Swaroop, Bero Lisa, Scherer Roberta W, Dickersin Kay
Center for Clinical Trials, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
N Engl J Med. 2009 Nov 12;361(20):1963-71. doi: 10.1056/NEJMsa0906126.
There is good evidence of selective outcome reporting in published reports of randomized trials.
We examined reporting practices for trials of gabapentin funded by Pfizer and Warner-Lambert's subsidiary, Parke-Davis (hereafter referred to as Pfizer and Parke-Davis) for off-label indications (prophylaxis against migraine and treatment of bipolar disorders, neuropathic pain, and nociceptive pain), comparing internal company documents with published reports.
We identified 20 clinical trials for which internal documents were available from Pfizer and Parke-Davis; of these trials, 12 were reported in publications. For 8 of the 12 reported trials, the primary outcome defined in the published report differed from that described in the protocol. Sources of disagreement included the introduction of a new primary outcome (in the case of 6 trials), failure to distinguish between primary and secondary outcomes (2 trials), relegation of primary outcomes to secondary outcomes (2 trials), and failure to report one or more protocol-defined primary outcomes (5 trials). Trials that presented findings that were not significant (P > or = 0.05) for the protocol-defined primary outcome in the internal documents either were not reported in full or were reported with a changed primary outcome. The primary outcome was changed in the case of 5 of 8 published trials for which statistically significant differences favoring gabapentin were reported. Of the 21 primary outcomes described in the protocols of the published trials, 6 were not reported at all and 4 were reported as secondary outcomes. Of 28 primary outcomes described in the published reports, 12 were newly introduced.
We identified selective outcome reporting for trials of off-label use of gabapentin. This practice threatens the validity of evidence for the effectiveness of off-label interventions.
在已发表的随机试验报告中，有充分证据表明存在选择性结果报告。
我们研究了辉瑞公司以及华纳-兰伯特公司的子公司帕克-戴维斯公司（以下简称辉瑞和帕克-戴维斯）资助的加巴喷丁用于非标签适应症（预防偏头痛以及治疗双相情感障碍、神经性疼痛和伤害性疼痛）试验的报告做法，将公司内部文件与已发表报告进行比较。
我们确定了20项辉瑞和帕克-戴维斯公司有内部文件的临床试验；其中12项试验在出版物中有所报道。在这12项已报道的试验中，有8项已发表报告中定义的主要结局与方案中描述的不同。分歧来源包括引入新的主要结局（6项试验）、未能区分主要和次要结局（2项试验）、将主要结局降为次要结局（2项试验）以及未报告一个或多个方案定义的主要结局（5项试验）。对于内部文件中方案定义的主要结局未显示显著结果（P≥0.05）的试验，要么未完整报告，要么报告时主要结局已改变。在已发表的8项报告显示加巴喷丁有统计学显著差异的试验中，有5项的主要结局发生了改变。在已发表试验方案中描述 的21个主要结局中，6个根本未报告，4个报告为次要结局。在已发表报告中描述的28个主要结局中，12个是新引入的。
我们发现加巴喷丁非标签使用试验存在选择性结果报告。这种做法威胁到非标签干预有效性证据的有效性。
