Bardy A H
National Agency for Medicines, Pharmacological Department, Helsinki, Finland.
Br J Clin Pharmacol. 1998 Aug;46(2):147-50. doi: 10.1046/j.1365-2125.1998.00759.x.
The primary aim of the present study was to identify possible occurrence of selective reporting of the results of clinical trials to the Finnish National Agency for Medicines. Selective reporting may lead to poorly informed action or inaction by regulatory authorities.
In 1987, 274 clinical drug trials were notified to the Finnish National Agency for Medicines. By December 1993, final reports had been received from 68 of these trials and statements that the trial had been suspended from 24 trials. The sponsors of the non-reported trials were requested to report the outcome. The outcomes, if any, of all reported and non-reported trials were classified as positive, inconclusive or negative.
The total number of trials with positive, inconclusive or negative outcome were 111, 33 and 44, respectively; the outcomes of 86 trials could not be assessed. Final reports were received from 42/111 (38%) trials with positive, 6/33 (18%) with inconclusive and 9/44 (20%) with negative outcomes.
Substantial evidence of selective reporting was detected, since trials with positive outcome resulted more often in submission of final report to regulatory authority than those with inconclusive or negative outcomes.
本研究的主要目的是确定向芬兰国家药品管理局选择性报告临床试验结果的可能情况。选择性报告可能导致监管机构做出信息不足的行动或不采取行动。
1987年，274项临床药物试验通知了芬兰国家药品管理局。到1993年12月，已收到其中68项试验的最终报告，另有24项试验已暂停。要求未报告试验的申办者报告试验结果。所有已报告和未报告试验的结果（如有）分为阳性、不确定或阴性。
结果为阳性、不确定或阴性的试验总数分别为111项、33项和44项；86项试验的结果无法评估。收到了42/111（38%）项阳性结果试验、6/33（18%）项不确定结果试验和9/44（20%）项阴性结果试验的最终报告。
检测到大量选择性报告的证据，因为与结果不确定或阴性的试验相比，结果为阳性的试验更常向监管机构提交最终报告。
