Weiss R B, Vogelzang N J, Peterson B A, Panasci L C, Carpenter J T, Gavigan M, Sartell K, Frei E, McIntyre O R
Department of Medicine, Walter Reed Army Medical Center, Washington, DC 20307.
JAMA. 1993 Jul 28;270(4):459-64.
To report on data collected during on-site audits of source documents in the Cancer and Leukemia Group B (CALGB).
A retrospective review of audit reports in four audit cycles.
A cooperative group of institutions conducting clinical trials in cancer treatment.
Patients taking part in clinical trials at collaborating CALGB institutions, members of the CALGB Data Audit Committee, and group chairmen of CALGB.
The results of 691 institutional audits conducted by the CALGB in 1982 through 1992 with comparisons of main CALGB institutions vs affiliates.
In four full reviews of all participating institutions in the CALGB, 3787 patients have had their on-site medical records compared with data submitted to the CALGB Data Management Center. Compliance with federal regulations for oversight by an institutional review board improved from a deficiency rate of 28.0% among the main institutions and 49.6% of the affiliate institutions in the first audit cycle to respective figures of 13.3% and 28.2% in the fourth cycle. Consent form deficiencies also dropped overall from 18.5% in the first cycle to 3.9% in the fourth. Patient eligibility was verified by auditors in 94.5%, and assessment of tumor changes in response to treatment was verified in 96.4% in the fourth cycle; both figures were only slightly lower in the first cycle. Two instances of scientific impropriety were discovered for a rate of only 0.28% of all audits. Both occurred prior to 1984, and none have occurred since. Major protocol deviations in drug dosing have held steady at about 11% over four audit cycles. Over the 11-year period of audits, three main institutions and 96 affiliate institutions have discontinued CALGB membership due solely, or at least partly, to unfavorable audit results.
Scientific improprieties have occurred very rarely in clinical trials conducted by the CALGB. Protocol compliance in assessing patient eligibility and tumor responses has been high. Attention to administrative matters of consent forms, institutional review board approval, and ancillary data submission has measurably improved in the CALGB, which is at least partly due to the pressure from this on-site peer review of investigator performance.
报告在癌症与白血病B组（CALGB）对源文件进行现场审核期间收集的数据。
对四个审核周期的审核报告进行回顾性分析。
一个开展癌症治疗临床试验的机构合作组。
在CALGB合作机构参与临床试验的患者、CALGB数据审核委员会成员以及CALGB的组长。
CALGB在1982年至1992年期间进行的691次机构审核结果，并比较CALGB主要机构与附属机构的情况。
在对CALGB所有参与机构进行的四次全面审核中，3787例患者的现场病历与提交给CALGB数据管理中心的数据进行了比对。主要机构中不符合联邦法规关于机构审查委员会监督要求的比例，从第一个审核周期的28.0%降至第四个周期的13.3%；附属机构的这一比例从49.6%降至28.2%。同意书缺陷率总体上也从第一个周期的18.5%降至第四个周期的3.9%。在第四个周期，审核人员核实患者合格性的比例为94.5%，核实肿瘤对治疗反应变化评估的比例为96.4%；在第一个周期，这两个比例仅略低。发现两起科学不当行为的案例，占所有审核的0.28%。两起案例均发生在1984年之前，此后未再发生。在四个审核周期中，药物剂量方面的主要方案偏差稳定在约11%。在11年的审核期间，三个主要机构和96个附属机构仅因审核结果不佳，或至少部分因此原因，而停止了CALGB成员资格。
在CALGB开展的临床试验中，科学不当行为极少发生。在评估患者合格性和肿瘤反应方面，方案依从性很高。CALGB在同意书、机构审查委员会批准和辅助数据提交等管理事项上的关注度有了显著提高，这至少部分归因于这种对研究者表现的现场同行评审所带来的压力。
