Department of Medical Oncology, Institut Bergonié, Regional Comprehensive Cancer Centre, Bordeaux.
Ann Oncol. 2014 Feb;25(2):536-41. doi: 10.1093/annonc/mdt550. Epub 2014 Jan 12.
Phase II trials represent an essential step in the development of anticancer drugs. This study assesses the quality of their reporting in highly ranked oncology journals, investigates predictive factors of quality, and proposes reporting guidelines.
We reviewed the table of contents of all volumes of eight peer-reviewed oncology journals published in English between January and December 2011 with a 2011 impact factor (IF)>4. Two reviewers assessed the quality of each report by using a 44-point overall quality score (OQS). Primary end point definition, justification of sample size, and definition of the evaluable population, were assessed separately to establish a 3-point key methodological score (KMS). Exploratory analyses identified predictive factors associated with scores.
One hundred fifty-six articles were included. The median OQS was 28 (range: 9-35). OQS subsection analysis showed that reporting of statistical methods was low with a median OQS of 3. Median KMS was 2 (range 0-3). Primary end point definition, justification of sample size and definition of the evaluable population were reported in only 107 (68.6%), 121 (77.6%), and 52 (33.3%) cases, respectively. At multivariate analysis, registration on clinicaltrials.gov and IF>10 were associated with improved OQS. No associations for KMS were observed.
Phase II trial reporting is still poor even in journals with strict editorial policies. This may lead to biased interpretation of phase II trial results. Besides using a checklist during the preparation of their manuscript, authors should also provide reviewers and readers with the last version of the study's protocol.
二期临床试验是抗癌药物开发的重要步骤。本研究评估了高排名肿瘤学期刊中此类试验报告的质量，调查了质量的预测因素，并提出了报告指南。
我们回顾了 2011 年 1 月至 12 月以英语出版、影响因子（IF）>4 的八本同行评议肿瘤学期刊的所有卷的目录。两名评审员使用 44 分的总体质量评分（OQS）评估每份报告的质量。分别评估主要终点定义、样本量的合理性和可评估人群的定义，以建立 3 分关键方法评分（KMS）。探索性分析确定了与评分相关的预测因素。
共纳入 156 篇文章。中位数 OQS 为 28（范围：9-35）。OQS 亚组分析显示，统计方法的报告率较低，中位数 OQS 为 3。中位数 KMS 为 2（范围 0-3）。仅在 107 例（68.6%）、121 例（77.6%）和 52 例（33.3%）中分别报告了主要终点定义、样本量合理性和可评估人群的定义。多变量分析显示，在 clinicaltrials.gov 上注册和 IF>10 与 OQS 的改善相关。未观察到 KMS 的相关性。
即使在具有严格编辑政策的期刊中，二期临床试验报告仍然很差。这可能导致对二期临床试验结果的有偏差解释。除了在准备手稿时使用清单外，作者还应向审稿人和读者提供研究方案的最新版本。
