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肿瘤学临床研究的全球化:现状、挑战与未来方向。

Globalization of clinical research in oncology: Status, challenges, and future directions.

机构信息

University Hospital for Tumors, Sestre milosrdnice University Hospital Center, Zagreb, Croatia.

University Hospital for Tumors, Sestre milosrdnice University Hospital Center, Zagreb, Croatia; University of Josip Juraj Strossmayer, Osijek, Croatia; University of Juraj Dobrila, Pula, Croatia.

出版信息

J Cancer Policy. 2024 Dec;42:100500. doi: 10.1016/j.jcpo.2024.100500. Epub 2024 Aug 10.

DOI:10.1016/j.jcpo.2024.100500
PMID:39134147
Abstract

PURPOSE

Cancer is the second-leading cause of death worldwide, and its burden is increasing around the world, particularly in low- and middle-income countries (LMICs). Yet, cancer research has historically been conducted primarily in high-income countries (HICs).

METHODS

In this review, we describe the results of our literature search into the current state of international cancer trials, including the benefits, challenges, limitations, and ethical concerns regarding the international conduct of HIC-led trials. We also propose some possible means of addressing these challenges and overcoming these barriers to extend the benefits of cancer research to people around the world.

RESULTS

Over the last several decades, there has been a shift toward inclusion of investigators and participants from LMICs in pivotal cancer clinical trials.

CONCLUSIONS

While inclusion of LMIC countries has benefits, including increased diversity of participant populations, investment in research infrastructure in LMICs, and potential expansion of cancer treatment options around the world, the continued leadership of most trials by HICs presents ethical concerns, including potential exploitation of researchers and participants from LMICs, lack of focus on cancer types prevalent in all participating regions, and disparities in access to approved therapies once the trial is complete.

摘要

目的

癌症是全球第二大致死原因,其负担在全球范围内不断增加,特别是在中低收入国家(LMICs)。然而,癌症研究历史上主要在高收入国家(HICs)进行。

方法

在本次综述中,我们描述了我们对国际癌症试验现状的文献检索结果,包括高收入国家主导的试验在国际上进行的益处、挑战、局限性和伦理问题。我们还提出了一些可能的方法来解决这些挑战,克服这些障碍,将癌症研究的惠益扩展到世界各地的人们。

结果

在过去几十年中,已经出现了一种趋势,即让来自 LMICs 的研究人员和参与者参与关键的癌症临床试验。

结论

虽然包括 LMIC 国家在内具有益处,包括参与者人群的多样性增加、在 LMICs 投资研究基础设施以及全球范围内潜在扩大癌症治疗选择,但大多数试验仍由 HICs 主导,这引发了一些伦理问题,包括对来自 LMICs 的研究人员和参与者的潜在剥削、缺乏对所有参与地区常见癌症类型的关注以及试验完成后获得批准治疗方法的机会不均等。

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