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巴西的癌症临床试验:卫生创新的局限性和可能性。

Cancer clinical trials in Brazil: Limitations and possibilities for health innovation.

机构信息

Clinical Research Division, Brazilian National Cancer Institute (INCA), Rua André Cavalcanti 37, Bairro de Fátima, Rio de Janeiro, 20231-050, Brazil.

Instituto Estadual do Cérebro Paulo Niemeyer (IECPN), Rua do Rezende, 156 - Centro, Rio de Janeiro, 20231-092, Brazil.

出版信息

J Cancer Policy. 2021 Sep;29:100290. doi: 10.1016/j.jcpo.2021.100290. Epub 2021 May 29.

Abstract

BACKGROUND

Brazil is a country of continental dimensions with great potential for the development of clinical studies across the whole territory to tackle the needs of the population. It is therefore important to obtain the national profile of clinical trials in order to identify local strengths and weaknesses in terms of productivity and study application. Thus, this paper aims to highlight the profiles of clinical studies on cancer developed and sponsored by hospitals, institutes, universities and international institutions in Brazil between 1997 and 2015.

METHODS

This is a retrospective and analytical study in which the content analysis method of Laurence Bardin was used. Data were collected from the clinicaltrials.govdatabase, where 783 clinical studies on cancer prevention, diagnosis and treatment were found; 188 (24 %) of these corresponded to national initiatives and 595 (76 %) to international initiatives.

RESULTS

The results show an increase in the number of national clinical studies, in particular phase III studies. There is a clear absence of national clinical studies focusing on the development of new chemical and biotechnological products in oncology.

CONCLUSION

The results indicate a regional imbalance in the distribution of national and international clinical trials.

POLICY SUMMARY

The present study aims to improve understanding of the profile of clinical studies registered in Brazil and to draw attention to the improvements needed in the health sector's productivity to address the national demand.

摘要

背景

巴西是一个幅员辽阔的国家,具有在全国范围内开展临床研究的巨大潜力,以满足人民的需求。因此,了解全国临床试验的概况对于确定在生产力和研究应用方面的本地优势和劣势非常重要。因此,本文旨在强调 1997 年至 2015 年间巴西的医院、研究所、大学和国际机构开展和赞助的癌症临床研究概况。

方法

这是一项回顾性和分析性研究,采用 Laurence Bardin 的内容分析法。数据来自于 clinicaltrials.gov 数据库,其中发现了 783 项癌症预防、诊断和治疗的临床研究;其中 188 项(24%)为国家倡议,595 项(76%)为国际倡议。

结果

结果显示,国家临床研究的数量有所增加,特别是 III 期研究。在肿瘤学中,几乎没有国家临床研究关注新的化学和生物技术产品的开发。

结论

结果表明,国家和国际临床试验的分布存在区域不平衡。

政策总结

本研究旨在提高对巴西注册的临床研究概况的理解,并提请注意卫生部门提高生产力以满足国家需求方面的改进。

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