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备受瞩目的研究经常且反复地呈现同一批患者的数据,尤其是在免疫治疗研究中。

High-profile studies frequently and repetitively present data on the same patients, particularly in immunotherapy studies.

作者信息

Ellis-Caleo Tim, Lisberg Aaron, Tucker D Andrew, Garon Edward B

机构信息

David Geffen School of Medicine, University of California Los Angeles, Los Angeles, USA.

Department of Medicine, University of California Los Angeles, Los Angeles, USA.

出版信息

J Thorac Dis. 2018 Feb;10(Suppl 3):S397-S403. doi: 10.21037/jtd.2018.01.110.

DOI:10.21037/jtd.2018.01.110
PMID:29593885
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5861271/
Abstract

BACKGROUND

Traditionally, study results have been presented as abstracts at major scientific meetings at the conclusion of the analysis. Recently, presentations of studies in progress and updates to previously presented data have been allowed at major meetings. The frequency and implications of a single study being presented multiple times, particularly in high profile oral presentations, have not been fully evaluated.

METHODS

To identify studies presented multiple times, abstracts from an approximately 1-year period from international conferences for three major societies devoted largely or in part to lung cancer research were assessed (ASCO 2015, World Lung 2015, ESMO 2015 and ASCO 2016). Abstracts were selected in a two-step process. The first step was for subject matter based on keywords: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) or immunotherapy. Searches differed slightly based on individual website functionality, with ASCO searched by track, World Lung by session and ESMO by individual abstract. In a second step, abstracts for which clinical outcome data was presented from a trial with an identifiable National Clinical Trial (NCT) number were selected. Immunotherapy abstracts that did not include the treatment of NSCLC or SCLC were excluded in the second step.

RESULTS

A total of 851 abstracts were identified that were related to NSCLC, SCLC or immunotherapy. Of these, 357 referred to a clinical trial. In total, 110 of 357 (31%) described clinical trials that were presented multiple times (mean 2.75, range 2-7), and in 44 (12%), this occurred at the same conference. Of the 113 oral presentations, 75 (66%) presented data from clinical trials, either as posters or oral presentations. Further, 35 of the 113 (31%) oral presentations presented data from clinical trials that had generated other oral presentations. Of the 16 unique clinical trials leading to multiple oral presentations, a variety of issues led to the duplicate presentations, including different cohorts of the same trial, biomarker analysis, analysis by one study variable, or simply updated data. Moreover, 107 of the 357 (30%) clinical trial abstracts pertained to immunotherapy, including 4 of the 16 clinical trials generating multiple oral presentations. Of the 16 trials generating multiple oral presentations, 11 (69%) lead to a full-length publication by July 2017, including all of those pertaining to immunotherapy.

CONCLUSIONS

There is a pattern of multiple presentations of clinical trials, particularly in oral presentations, at major meetings. In most cases, data presented in subsequent oral presentations related entirely to patients whose data was presented in the previous oral presentation.

摘要

背景

传统上,研究结果在分析结束时会在主要科学会议上以摘要形式呈现。最近,主要会议已允许展示正在进行的研究以及对先前展示数据的更新。一项研究多次展示的频率及其影响,尤其是在备受瞩目的口头报告中,尚未得到充分评估。

方法

为了识别多次展示的研究,我们评估了来自三个主要致力于肺癌研究的国际会议大约1年期间的摘要(2015年美国临床肿瘤学会年会、2015年世界肺癌大会、2015年欧洲肿瘤内科学会年会和2016年美国临床肿瘤学会年会)。摘要通过两步筛选过程选出。第一步基于关键词筛选主题:非小细胞肺癌(NSCLC)、小细胞肺癌(SCLC)或免疫疗法。根据各个网站功能的不同,搜索方式略有差异,美国临床肿瘤学会年会按专题搜索,世界肺癌大会按场次搜索,欧洲肿瘤内科学会年会按单个摘要搜索。第二步,选择那些来自具有可识别的国家临床试验(NCT)编号的试验且展示了临床结局数据的摘要。在第二步中,排除了未包括NSCLC或SCLC治疗的免疫疗法摘要。

结果

共识别出851篇与NSCLC、SCLC或免疫疗法相关的摘要。其中,357篇涉及一项临床试验。总体而言,357篇中的110篇(31%)描述了多次展示的临床试验(平均2.75次,范围2 - 7次),其中44篇(12%)在同一次会议上出现这种情况。在113次口头报告中,75次(66%)展示了来自临床试验的数据,以海报或口头报告形式呈现。此外,113次口头报告中的35次(31%)展示了来自已产生其他口头报告的临床试验的数据。在导致多次口头报告的16项独特临床试验中,多种问题导致了重复展示,包括同一试验的不同队列、生物标志物分析、按一个研究变量进行的分析,或者仅仅是更新的数据。此外,357篇临床试验摘要中的107篇(30%)与免疫疗法有关,包括16项产生多次口头报告的临床试验中的4项。在16项产生多次口头报告的试验中,11项(69%)在2017年7月前发表了全文,包括所有与免疫疗法相关的试验。

结论

在主要会议上存在临床试验多次展示的模式,尤其是在口头报告中。在大多数情况下,后续口头报告中展示的数据完全与先前口头报告中展示数据的患者相关。

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