ClinicalTrials.gov 上登记的 3 期交叉试验。

Registration of phase 3 crossover trials on ClinicalTrials.gov.

机构信息

Statistics Collaborative, Inc, Washington, D. C., USA.

Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Heath, Baltimore, MD, USA.

出版信息

Trials. 2020 Jul 6;21(1):613. doi: 10.1186/s13063-020-04545-2.

DOI:10.1186/s13063-020-04545-2

PMID:32631413

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7336618/

Abstract

BACKGROUND

In a randomized crossover trial, each participant is randomized to a sequence of treatments and treatment effect is estimated based on within-individual difference because each participant serves as his/her own control. This feature makes the design and reporting of randomized crossover trials different from that of parallel trials. Our objective was to characterize phase 3 crossover trials with results reported on ClinicalTrials.gov and identify issues and best practices for reporting.

METHODS

We searched ClinicalTrials.gov for phase 3 randomized crossover trials that provided results, registered at least one primary outcome, and included at least one link to a results publication in the record by August 6, 2019. Two reviewers independently assessed the eligibility and extracted information from each record into an electronic form developed and maintained in the Systematic Review Data Repository.

RESULTS

Of the 124 crossover trials analyzed, two thirds were a simple "Intervention A then B" or "Intervention B then A" (AB|BA) design. Most trials (78%, 97/124) provided enough information to understand the participant flow throughout the trial. Baseline characteristics were most often reported for all participants as a single group (52%, 65/124). Primary outcomes and adverse events were most commonly reported "per intervention" (85%, 105/124, and 80%, 99/124, respectively).

CONCLUSIONS

The registration and reporting of randomized crossover trials must account for the paired nature of the design. Our observations and recommendations informed the development of guidelines for good reporting practices in the registration and reporting of randomized crossover trials.

摘要

背景

在一项随机交叉试验中，每个参与者都被随机分配到一系列治疗方案中，并且根据个体内差异来估计治疗效果，因为每个参与者都是自己的对照。这一特点使得随机交叉试验的设计和报告与平行试验有所不同。我们的目的是描述在 ClinicalTrials.gov 上报告结果的 3 期交叉试验，并确定报告的问题和最佳实践。

方法

我们在 ClinicalTrials.gov 上搜索了已报告结果的 3 期随机交叉试验，这些试验至少注册了一个主要结局，并在记录中至少链接到一个结果出版物，搜索时间截至 2019 年 8 月 6 日。两名评审员独立评估了每个记录的资格，并将信息从每个记录中提取到一个电子表格中，该表格是在系统评价数据仓库中开发和维护的。

结果

在分析的 124 项交叉试验中，有三分之二是简单的“干预 A 后 B”或“干预 B 后 A”（AB|BA）设计。大多数试验（78%，97/124）提供了足够的信息，以便了解整个试验过程中参与者的流动情况。基线特征通常以单个组的形式报告给所有参与者（52%，65/124）。主要结局和不良事件最常按“每一种干预”报告（85%，105/124 和 80%，99/124）。