一个阶段二试验的统计计划应该平衡最小化潜在有益的治疗过早终止（即假阴性）和进一步昂贵的无效药物测试（即假阳性）。我们旨在审查近年来阶段二肿瘤学试验结果的方法论、报告和解读偏见。在一项回顾性横断面分析中，我们回顾了2021年1月1日至2022年6月20日PubMed上发表的所有全文文章。我们寻找有关样本量计算（数量、α值、功效和预期效应大小）、主要和次要结果，以及作者对研究结论的数据。约5.4％的研究（n = 10）使用的统计功效低于80％，16.7％（n = 34）未表明样本量计算的功效水平。约16.7％的研究（n = 31）使用单侧α水平≤0.025；17.7％的研究（n = 33）使用预定义的阈值（无比较器效应大小或组之间的差异）来确定功效的样本量。作者结论为积极但没有达到主要终点或终点不确定的研究占27.4％（n = 51）。许多肿瘤学中的随机阶段II研究没有报告确定样本量计算所需的基本数据，尽管这些研究是随机的，但许多并未实际使用比较器来确定功效，并且许多结论为积极，即使结果不确定或主要终点未达到。版权所有©2022年作者。由Elsevier Ltd.出版。保留所有权利。

The statistical plan of a phase II trial should balance minimizing the premature termination of potentially beneficial therapies (i.e. false negatives) and the further, costly testing of ineffective drugs (i.e. false positives). We sought to examine the methodology, reporting, and bias in the interpretation of outcomes of phase II oncology trials in recent years.In a retrospective cross-sectional analysis, we reviewed all full-length articles published on PubMed from 1 January 2021 to 20 June 2022. We searched for data regarding the sample size calculation (number, α value, power, and expected effect size), the primary and secondary outcomes and results, and the authors' conclusion of the study.About 5.4% of studies (n = 10) used a statistical power that was inferior to 80%, and 16.7% (n = 34) did not indicate the level of power for the sample size calculation. Approximately 16.7% (n = 31) of studies used a one-sided α level of ≤0.025; 17.7% (n = 33) of studies used a predefined threshold (no comparator effect size or difference between groups) to determine the sample size for efficacy. The percentage of studies with a positive authors' conclusion but not meeting the primary endpoint, or the endpoint was equivocal, was 27.4% (n = 51).Many randomized phase II studies in oncology failed to report essential data for determining sample size calculations, many did not actually use a comparator to determine efficacy even though the studies were randomized, and many had positive conclusions even though the results were indeterminate or the primary endpoint was not met.Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.