报告 ClinicalTrials.gov 结果数据库与同行评议出版物之间的差异。

Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.

出版信息

Ann Intern Med. 2014 Apr 1;160(7):477-83. doi: 10.7326/M13-0480.

DOI:10.7326/M13-0480

PMID:24687070

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4617780/

Abstract

BACKGROUND

ClinicalTrials.gov requires reporting of result summaries for many drug and device trials.

PURPOSE

To evaluate the consistency of reporting of trials that are registered in the ClinicalTrials.gov results database and published in the literature.

DATA SOURCES

ClinicalTrials.gov results database and matched publications identified through ClinicalTrials.gov and a manual search of 2 electronic databases.

STUDY SELECTION

10% random sample of phase 3 or 4 trials with results in the ClinicalTrials.gov results database, completed before 1 January 2009, with 2 or more groups.

DATA EXTRACTION

One reviewer extracted data about trial design and results from the results database and matching publications. A subsample was independently verified.

DATA SYNTHESIS

Of 110 trials with results, most were industry-sponsored, parallel-design drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). Sixteen trials (15%) reported the primary outcome description inconsistently, and 22 (20%) reported the primary outcome value inconsistently. Thirty-eight trials inconsistently reported the number of individuals with a serious adverse event (SAE); of these, 33 (87%) reported more SAEs in ClinicalTrials.gov. Among the 84 trials that reported SAEs in ClinicalTrials.gov, 11 publications did not mention SAEs, 5 reported them as zero or not occurring, and 21 reported a different number of SAEs. Among 29 trials that reported deaths in ClinicalTrials.gov, 28% differed from the matched publication.

LIMITATION

Small sample that included earliest results posted to the database.

CONCLUSION

Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. Which source contains the more accurate account of results is unclear, although ClinicalTrials.gov may provide a more comprehensive description of adverse events than the publication.

PRIMARY FUNDING SOURCE

Agency for Healthcare Research and Quality.

摘要

背景

ClinicalTrials.gov 要求报告许多药物和设备试验的结果摘要。

目的

评估在 ClinicalTrials.gov 结果数据库中注册并在文献中发表的试验报告的一致性。

数据来源

ClinicalTrials.gov 结果数据库和通过 ClinicalTrials.gov 以及手动搜索 2 个电子数据库确定的匹配出版物。

研究选择

ClinicalTrials.gov 结果数据库中具有结果的 10%随机抽取的 3 期或 4 期试验，于 2009 年 1 月 1 日前完成，有 2 个或更多组。

数据提取

一位审查员从结果数据库和匹配出版物中提取有关试验设计和结果的数据。抽取了一个子样本进行独立验证。

数据综合

在 110 项具有结果的试验中，大多数为工业资助的、平行设计的药物研究。最常见的不一致是报告的次要结局指标数量（80%）。16 项试验（15%）报告的主要结局描述不一致，22 项试验（20%）报告的主要结局值不一致。38 项试验不一致地报告了有严重不良事件（SAE）的个体数量；其中，33 项试验（87%）在 ClinicalTrials.gov 中报告了更多的 SAE。在 84 项在 ClinicalTrials.gov 中报告了 SAE 的试验中，有 11 项出版物未提及 SAE，5 项报告为零或未发生，21 项报告了不同数量的 SAE。在 29 项在 ClinicalTrials.gov 中报告死亡的试验中，有 28%与匹配的出版物不同。

局限性

小样本，包括最早发布到数据库的结果。

结论

ClinicalTrials.gov 结果数据库与匹配出版物之间的报告差异很常见。哪个来源包含更准确的结果尚不清楚，尽管 ClinicalTrials.gov 可能比出版物更全面地描述不良事件。

主要资金来源

医疗保健研究和质量局。

相似文献

Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.

Ann Intern Med. 2014 Apr 1;160(7):477-83. doi: 10.7326/M13-0480.

Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles.

BMC Med. 2015 Aug 14;13:189. doi: 10.1186/s12916-015-0430-4.

Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

Invest New Drugs. 2017 Dec;35(6):827-833. doi: 10.1007/s10637-017-0510-8. Epub 2017 Sep 14.

ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials.

Ann Intern Med. 2016 Sep 20;165(6):421-30. doi: 10.7326/M15-2658. Epub 2016 Jun 14.

Do Published Data in Trials Assessing Cancer Drugs Reflect the Real Picture of Efficacy and Safety?

J Natl Compr Canc Netw. 2017 Nov;15(11):1363-1371. doi: 10.6004/jnccn.2017.7002.

Reporting discrepancies between the clinicaltrials.gov results database and peer-reviewed publications.

Ann Intern Med. 2014 Nov 18;161(10):760. doi: 10.7326/L14-5022.

Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals.

PLoS Med. 2013 Dec;10(12):e1001566; discussion e1001566. doi: 10.1371/journal.pmed.1001566. Epub 2013 Dec 3.

Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: a cross-sectional study.

BMJ Open. 2014 Jul 9;4(7):e005535. doi: 10.1136/bmjopen-2014-005535.

Selective reporting bias in randomised controlled trials from two network meta-analyses: comparison of clinical trial registrations and their respective publications.

BMJ Open. 2019 Sep 5;9(9):e031138. doi: 10.1136/bmjopen-2019-031138.

Comparison of reporting phase III randomized controlled trials of antibiotic treatment for common bacterial infections in ClinicalTrials.gov and matched publications.

Clin Microbiol Infect. 2018 Nov;24(11):1211.e9-1211.e14. doi: 10.1016/j.cmi.2018.02.010. Epub 2018 Feb 15.

引用本文的文献

Nonregistration, Discontinuation, and Nonpublication of Randomized Trials: A Systematic Review.

JAMA Netw Open. 2025 Sep 2;8(9):e2524440. doi: 10.1001/jamanetworkopen.2025.24440.

Practice of data sharing plans in clinical trial registrations and concordance between registered and published data sharing plans: a cross-sectional study.

BMC Med. 2025 Sep 1;23(1):510. doi: 10.1186/s12916-025-04328-z.

Concordance between clinical trial data use request proposals and corresponding publications: A cross-sectional study.

Clin Trials. 2025 Jun;22(3):279-288. doi: 10.1177/17407745241304355. Epub 2024 Dec 29.

Risk of Ophthalmotoxicity Associated with Antibody-Drug Conjugates: A Systematic Review and Meta-analysis.

Clin Drug Investig. 2025 May 14. doi: 10.1007/s40261-025-01447-6.

Computational tools and data integration to accelerate vaccine development: challenges, opportunities, and future directions.

Front Immunol. 2025 Mar 7;16:1502484. doi: 10.3389/fimmu.2025.1502484. eCollection 2025.

Discrepancies in reported results between trial registries and journal articles for AI clinical research.

EClinicalMedicine. 2025 Jan 20;80:103066. doi: 10.1016/j.eclinm.2024.103066. eCollection 2025 Feb.

An analysis of controlled human infection studies registered on ClinicalTrials.gov.

BMJ Open. 2025 Feb 7;15(2):e085250. doi: 10.1136/bmjopen-2024-085250.

Discrepancies in safety reporting for chronic back pain clinical trials: an observational study from ClinicalTrials.gov and publications.

BMC Med Res Methodol. 2025 Feb 6;25(1):33. doi: 10.1186/s12874-025-02486-5.

Protocol publication rate and comparison between article, registry and protocol in RCTs.

BMC Med Res Methodol. 2025 Feb 1;25(1):31. doi: 10.1186/s12874-025-02471-y.

Discordant Information on Blinding in Trial Registries and Published Research: A Systematic Review.

JAMA Netw Open. 2024 Dec 2;7(12):e2452274. doi: 10.1001/jamanetworkopen.2024.52274.

本文引用的文献

Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: a systematic review and meta-analysis.

Ann Intern Med. 2013 Jun 18;158(12):890-902. doi: 10.7326/0003-4819-158-12-201306180-00006.

Ushering in a new era of open science through data sharing: the wall must come down.

JAMA. 2013 Apr 3;309(13):1355-6. doi: 10.1001/jama.2013.1299.

Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications-a cross-sectional study.

BMJ Open. 2013 Jan 18;3(1):e001963. doi: 10.1136/bmjopen-2012-001963.

A model for dissemination and independent analysis of industry data.

JAMA. 2011 Oct 12;306(14):1593-4. doi: 10.1001/jama.2011.1459.

Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy.

PLoS One. 2011;6(9):e25258. doi: 10.1371/journal.pone.0025258. Epub 2011 Sep 21.

A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned.

Spine J. 2011 Jun;11(6):471-91. doi: 10.1016/j.spinee.2011.04.023.

The ClinicalTrials.gov results database--update and key issues.

N Engl J Med. 2011 Mar 3;364(9):852-60. doi: 10.1056/NEJMsa1012065.

Dissemination and publication of research findings: an updated review of related biases.

Health Technol Assess. 2010 Feb;14(8):iii, ix-xi, 1-193. doi: 10.3310/hta14080.

Undisclosed changes in outcomes in randomized controlled trials: an observational study.

Ann Fam Med. 2009 Nov-Dec;7(6):542-6. doi: 10.1370/afm.1017.

Reporting of safety results in published reports of randomized controlled trials.

Arch Intern Med. 2009 Oct 26;169(19):1756-61. doi: 10.1001/archinternmed.2009.306.

文献AI研究员

20分钟写一篇综述，助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型，支持多种主流文档格式。

立即体验

报告 ClinicalTrials.gov 结果数据库与同行评议出版物之间的差异。

Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.

出版信息

Ann Intern Med. 2014 Apr 1;160(7):477-83. doi: 10.7326/M13-0480.

DOI:10.7326/M13-0480

PMID:24687070

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4617780/

Abstract

BACKGROUND

ClinicalTrials.gov requires reporting of result summaries for many drug and device trials.

PURPOSE

To evaluate the consistency of reporting of trials that are registered in the ClinicalTrials.gov results database and published in the literature.

DATA SOURCES

ClinicalTrials.gov results database and matched publications identified through ClinicalTrials.gov and a manual search of 2 electronic databases.

STUDY SELECTION

10% random sample of phase 3 or 4 trials with results in the ClinicalTrials.gov results database, completed before 1 January 2009, with 2 or more groups.

DATA EXTRACTION

One reviewer extracted data about trial design and results from the results database and matching publications. A subsample was independently verified.

DATA SYNTHESIS

LIMITATION

Small sample that included earliest results posted to the database.

CONCLUSION

PRIMARY FUNDING SOURCE

Agency for Healthcare Research and Quality.

摘要

背景

ClinicalTrials.gov 要求报告许多药物和设备试验的结果摘要。

目的

评估在 ClinicalTrials.gov 结果数据库中注册并在文献中发表的试验报告的一致性。

数据来源

ClinicalTrials.gov 结果数据库和通过 ClinicalTrials.gov 以及手动搜索 2 个电子数据库确定的匹配出版物。

研究选择

ClinicalTrials.gov 结果数据库中具有结果的 10%随机抽取的 3 期或 4 期试验，于 2009 年 1 月 1 日前完成，有 2 个或更多组。

数据提取

一位审查员从结果数据库和匹配出版物中提取有关试验设计和结果的数据。抽取了一个子样本进行独立验证。

报告 ClinicalTrials.gov 结果数据库与同行评议出版物之间的差异。

Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.

出版信息

BACKGROUND

PURPOSE

DATA SOURCES

STUDY SELECTION

DATA EXTRACTION

DATA SYNTHESIS

LIMITATION

CONCLUSION

PRIMARY FUNDING SOURCE

背景

目的

数据来源

研究选择

数据提取

数据综合

局限性

结论

主要资金来源

相似文献

引用本文的文献

本文引用的文献

文献AI研究员

用中文搜PubMed

文档翻译

Suppr 超能文献

报告 ClinicalTrials.gov 结果数据库与同行评议出版物之间的差异。

Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.

出版信息

BACKGROUND

PURPOSE

DATA SOURCES

STUDY SELECTION

DATA EXTRACTION

DATA SYNTHESIS

LIMITATION

CONCLUSION

PRIMARY FUNDING SOURCE

背景

目的

数据来源

研究选择

数据提取

数据综合

局限性

结论

主要资金来源