PUBLICATION BIAS - THE CASE FOR AN INTERNATIONAL REGISTRY OF CLINICAL-TRIALS
PUBLICATION BIAS - THE CASE FOR AN INTERNATIONAL REGISTRY OF CLINICAL-TRIALS
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DOI：
10.1200/jco.1986.4.10.1529
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发表时间：
1986-10-01
影响因子：
45.3
通讯作者：
SIMES, RJ
中科院分区：
文献类型：
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作者：
SIMES, RJ
从临床试验综述中评估不同疗法的一个问题是，已发表的临床试验文献可能偏向于积极或有希望的结果。在本报告中，提出了一个模型，用于审查临床试验结果，该模型基于预先在注册中心注册的试验的选择，不存在发表偏倚。通过比较文献检索定位的已发表临床试验综述与癌症试验注册表中包含的已注册试验综述，说明了注册表的价值。研究了两个治疗问题：（1）晚期卵巢癌中初始烷化剂（AA）与联合化疗（CC）的生存影响，以及（2）多发性骨髓瘤中AA/泼尼松与CC的生存影响。在晚期卵巢癌中，对已发表的临床试验的汇总分析表明，联合化疗具有显著的生存优势（CC与AA的中位生存率比为1.16; P = 0.02）。然而，基于对注册试验的汇总分析，没有证明生存率有显著差异（中位生存率，1.05; P = 0.25）。对于多发性骨髓瘤，对已发表试验的汇总分析也表明CC具有显著的生存优势（中位生存率，1.26; P = .04），特别是对于低风险患者（比率，1.66; P = .002）。对注册试验的汇总分析也显示接受联合化疗的患者的生存获益（所有患者，P = 0.06;不良风险，P = 0.03），但估计的获益幅度降低（所有患者：比率，1.11;不良风险：比率，1.22）。这些例子说明了一种审查临床试验文献的方法，这种方法没有发表偏倚，并证明了所有临床试验的国际注册的价值和重要性。
A problem in evaluating different therapies from a review of clinical trials is that the published clinical trial literature may be biased in favor of positive or promising results. In this report, a model is proposed for reviewing clinical trial results which is free from publication bias based on the selection of trials registered in advance in a registry. The value of a registry is illustrated by comparing a review of published clinical trials located by a literature search with a review of registered trials contained in a cancer trials registry. Two therapeutic questions are examined: (1) the survival impact of initial alkylating agent (AA) v combination chemotherapy (CC) in advanced ovarian cancer, and (2) the survival impact of AA/prednisone v CC in multiple myeloma. In advanced ovarian cancer, a pooled analysis of published clinical trials demonstrates a significant survival advantage for combination chemotherapy (median survival ratio of CC to AA, 1.16; P = .02). However, no significant difference in survival is demonstrated based on a pooled analysis of registered trials (median survival ratio, 1.05; P = .25). For multiple myeloma, a pooled analysis of published trials also demonstrates a significant survival advantage for CC (median survival ratio, 1.26; P = .04), especially for poor risk patients (ratio, 1.66; P = .002). A pooled analysis of registered trials also shows a survival benefit for patients receiving combination chemotherapy (all patients, P = .06; poor risk, P = .03), but the estimated magnitude of the benefit is reduced (all patients: ratio, 1.11; poor risk: ratio, 1.22). These examples illustrate an approach to reviewing the clinical trial literature, which is free from publication bias, and demonstrate the value and importance of an international registry of all clinical trials.