Jones Christopher W, Misemer Benjamin S, Platts-Mills Timothy F, Ahn Rosa, Woodbridge Alexandra, Abraham Ann, Saba Susan, Korenstein Deborah, Madden Erin, Keyhani Salomeh
Department of Emergency Medicine, Cooper Medical School of Rowan University, Camden, New Jersey, USA.
Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
BMJ Open. 2018 Feb 8;8(2):e019831. doi: 10.1136/bmjopen-2017-019831.
To determine the relationship between manufacturer-related financial ties among investigators of published drug trials and rates of discrepant registered and published primary trial outcomes.
Cross-sectional study.
Human subjects drug trials published in 'core clinical' MEDLINE journals in 2013.
The primary study endpoint was the presence of a prospectively registered, clearly defined primary outcome that matched the published primary outcome for each included trial. Secondary outcomes included assessments of registration timing and quality, and the impact of outcome discrepancies between registration and publication on the statistical significance of the included trials.
Of 192 included trials, 134 (70%) were positive and 58 (30%) were negative. Financial ties were present between first or last authors and drug manufacturers for 130 trials (68%), of which 78% were positive, versus 53% of trials with no financial ties that were positive. Clearly defined, prospectively registered outcomes that matched the published outcomes were present in just 76 of the 192 trials (40%). After adjusting for study start date and sample size, the observed relationship between investigator financial ties and the presence of a match between prospectively registered and published primary outcomes was of borderline statistical significance (OR 2.12, 95% CI 0.998 to 4.50). Studies with financial ties present were more likely than studies without ties to have been prospectively registered (78%vs48%, P<0.001) and were more likely to have prospectively registered a clearly defined primary outcome(62%vs35%, P<0.001).
Less than half of the trials in this cohort were prospectively registered with a clear primary outcome that was consistent with the primary outcome reported in the published manuscript. The presence of investigator financial ties was associated with higher quality registration practices, though this association diminished after adjusting for factors that impact registration quality.
确定已发表药物试验的研究者与制造商之间的财务关系，以及注册的主要试验结果与发表的主要试验结果不符率之间的关系。
横断面研究。
2013年发表于“核心临床”MEDLINE期刊上的人体药物试验。
主要研究终点是每项纳入试验是否存在前瞻性注册、明确界定且与发表的主要结局相匹配的主要结局。次要结局包括对注册时间和质量的评估，以及注册与发表之间结局差异对纳入试验统计学显著性的影响。
在192项纳入试验中，134项（70%）为阳性，58项（30%）为阴性。130项试验（68%）的第一或最后作者与药物制造商存在财务关系，其中78%为阳性试验，而无财务关系的试验中阳性比例为53%。在192项试验中，仅有76项（40%）存在明确界定、前瞻性注册且与发表结局相匹配的结局。在对研究开始日期和样本量进行校正后，研究者财务关系与前瞻性注册和发表的主要结局之间存在匹配这一观察到的关系具有临界统计学显著性（比值比2.12，95%置信区间0.998至4.50）。有财务关系的研究比无财务关系的研究更有可能进行前瞻性注册（78%对48%，P<0.001），且更有可能前瞻性注册明确界定的主要结局（62%对35%，P<0.001）。
该队列中不到一半的试验进行了前瞻性注册，且明确的主要结局与发表稿件中报告的主要结局一致。研究者财务关系的存在与更高质量的注册实践相关，不过在对影响注册质量的因素进行校正后，这种关联减弱。
