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证据现状:全球临床试验差异调查。

State of the evidence: a survey of global disparities in clinical trials.

机构信息

School of Population Health and Environmental Sciences, King's College London, London, UK

School of Population Health and Environmental Sciences, King's College London, London, UK.

出版信息

BMJ Glob Health. 2021 Jan;6(1). doi: 10.1136/bmjgh-2020-004145.

DOI:10.1136/bmjgh-2020-004145
PMID:33402333
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7786802/
Abstract

INTRODUCTION

Ideally, health conditions causing the greatest global disease burden should attract increased research attention. We conducted a comprehensive global study investigating the number of randomised controlled trials (RCTs) published on different health conditions, and how this compares with the global disease burden that they impose.

METHODS

We use machine learning to monitor PubMed daily, and find and analyse RCT reports. We assessed RCTs investigating the leading causes of morbidity and mortality from the Global Burden of Disease study. Using regression models, we compared numbers of actual RCTs in different health conditions to numbers predicted from their global disease burden (disability-adjusted life years (DALYs)). We investigated whether RCT numbers differed for conditions disproportionately affecting countries with lower socioeconomic development.

RESULTS

We estimate 463 000 articles describing RCTs (95% prediction interval 439 000 to 485 000) were published from 1990 to July 2020. RCTs recruited a median of 72 participants (IQR 32-195). 82% of RCTs were conducted by researchers in the top fifth of countries by socio-economic development. As DALYs increased for a particular health condition by 10%, the number of RCTs in the same year increased by 5% (3.2%-6.9%), but the association was weak (adjusted R=0.13). Conditions disproportionately affecting countries with lower socioeconomic development, including respiratory infections and tuberculosis (7000 RCTs below predicted) and enteric infections (9700 RCTs below predicted), appear relatively under-researched for their disease burden. Each 10% shift in DALYs towards countries with low and middle socioeconomic development was associated with a 4% reduction in RCTs (3.7%-4.9%). These disparities have not changed substantially over time.

CONCLUSION

Research priorities are not well optimised to reduce the global burden of disease. Most RCTs are produced by highly developed countries, and the health needs of these countries have been, on average, favoured.

摘要

引言

理想情况下,对造成全球最大疾病负担的健康问题应给予更多的研究关注。我们进行了一项全面的全球研究,调查了不同健康状况的随机对照试验(RCT)的数量,以及这些研究与它们造成的全球疾病负担相比如何。

方法

我们使用机器学习技术每天监测 PubMed,并查找和分析 RCT 报告。我们评估了调查全球疾病负担研究中发病率和死亡率主要原因的 RCT。我们使用回归模型,将不同健康状况下实际 RCT 的数量与根据其全球疾病负担(伤残调整生命年(DALYs))预测的数量进行了比较。我们调查了 RCT 数量是否因不成比例地影响社会经济发展水平较低的国家的疾病状况而有所不同。

结果

我们估计,1990 年至 2020 年 7 月,发表了描述 RCT 的 463000 篇文章(95%预测区间为 439000 至 485000)。RCT 平均招募了 72 名参与者(IQR 32-195)。82%的 RCT 是由社会经济发展水平最高的五分之一国家的研究人员进行的。对于特定的健康状况,DALYs 每增加 10%,同年的 RCT 数量就会增加 5%(3.2%-6.9%),但相关性较弱(调整后的 R=0.13)。不成比例地影响社会经济发展水平较低国家的疾病状况,包括呼吸道感染和结核病(实际 RCT 数量比预测值低 7000 项)和肠道感染(实际 RCT 数量比预测值低 9700 项),似乎与其疾病负担相比相对研究不足。DALYs 向低中等社会经济发展国家转移 10%,与 RCT 减少 4%(3.7%-4.9%)相关。这些差异在时间上没有明显变化。

结论

研究重点没有很好地优化,以减轻全球疾病负担。大多数 RCT 都是由高度发达的国家进行的,这些国家的健康需求平均得到了优先考虑。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d44/7786802/e60274555331/bmjgh-2020-004145f05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d44/7786802/096885e87498/bmjgh-2020-004145f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d44/7786802/f30c14e8fe46/bmjgh-2020-004145f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d44/7786802/632092c279b3/bmjgh-2020-004145f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d44/7786802/eb3068d4cf24/bmjgh-2020-004145f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d44/7786802/e60274555331/bmjgh-2020-004145f05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d44/7786802/096885e87498/bmjgh-2020-004145f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d44/7786802/f30c14e8fe46/bmjgh-2020-004145f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d44/7786802/632092c279b3/bmjgh-2020-004145f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d44/7786802/eb3068d4cf24/bmjgh-2020-004145f04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d44/7786802/e60274555331/bmjgh-2020-004145f05.jpg

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