III期癌症试验中伦理要求的方法学质量与报告

Methodological quality and reporting of ethical requirements in phase III cancer trials.

作者信息

Tuech J J, Pessaux P, Moutel G, Thoma V, Schraub S, Herve C

机构信息

Laboratoire d'Ethique Médicale et de Santé Publique, Faculté de Médecine Necker, Université Paris René Descartes, France.

出版信息

J Med Ethics. 2005 May;31(5):251-5. doi: 10.1136/jme.2003.007435.

DOI:10.1136/jme.2003.007435

PMID:15863678

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1734140/

Abstract

BACKGROUND

The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials.

METHOD

Methodological quality (Jadad score) and ethical quality (Berdeu score) were assessed for all randomised controlled trials (RCTs) published in 10 international journals between 1999 and 2001 (n = 231).

RESULTS

The mean Jadad score was 9.86 +/- 1.117. The methodological quality was poor in 75 RCTs (Jadad score <9). The mean Berdeu score was 0.42 +/- 0.133. The mean ethical quality score for poor methodological quality RCTs (n = 75) was 0.39 +/- 0.133; it was 0.43 +/- 0.133 for good (n = 156) methodological quality RCTs (p = 0.07). There was improvement in ethical quality according to the year of commencement of the trials (p < 0.001). There was no correlation between methodological quality and the number of participating patients (R2 = 0.003, p = 0.78), between ethical quality and the number of participating patients (R2 = 0.003, p = 0.76 ), or between ethical quality and methodological quality (R2 = 0.012, p = 0.1). ICP and REC approval were not obtained for 21 and 77 trials respectively.

CONCLUSION

The association between methodological quality and the reporting of ethical requirements probably reflects the respect shown for patients during the whole research process. These results suggest that closer attention to the conduct of clinical research, as well as the reporting of its ethical aspects, is needed.

摘要

背景

研究伦理委员会（REC）的批准以及获得患者的知情同意（ICP）可被视为人类研究伦理中的主要问题。本研究的目的是评估方法学质量和伦理质量，并评估这两种质量在随机III期癌症试验中的关系。

方法

对1999年至2001年期间在10种国际期刊上发表的所有随机对照试验（RCT）（n = 231）评估方法学质量（Jadad评分）和伦理质量（Berdeu评分）。

结果

Jadad评分的平均值为9.86±1.117。75项RCT的方法学质量较差（Jadad评分<9）。Berdeu评分的平均值为0.42±0.133。方法学质量较差的RCT（n = 75）的伦理质量平均评分为0.39±0.133；方法学质量良好的RCT（n = 156）为0.43±0.133（p = 0.07）。根据试验开始年份，伦理质量有所改善（p < 0.001）。方法学质量与参与患者数量之间无相关性（R2 = 0.003，p = 0.78），伦理质量与参与患者数量之间无相关性（R2 = 0.003，p = 0.76），伦理质量与方法学质量之间也无相关性（R2 = 0.012，p = 0.1）。分别有21项和77项试验未获得ICP和REC批准。