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非洲临床试验的运营策略

Operational Strategies for Clinical Trials in Africa.

作者信息

Graef Katy M, Okoye Ifeoma, Ohene Oti Naomi O, Dent Jennifer, Odedina Folakemi T

机构信息

BIO Ventures for Global Health, Seattle, WA.

Department of Radiology, College of Medicine, University of Nigeria, Nsukka, Nigeria.

出版信息

JCO Glob Oncol. 2020 Jun;6:973-982. doi: 10.1200/JGO.19.00204.

Abstract

PURPOSE

In a dramatic reversal of longstanding trends, cancer now kills more Africans than malaria. Despite Africa's growing cancer burden, individuals of African descent, notably those residing in Africa, remain drastically under-represented in cancer clinical trials. Two recent summits-the 1st All Africa Clinical Trial Summit and the Operational Strategy for Clinical Trials in Nigeria Summit-convened experts from governments, the private sector, universities, and professional societies to define the barriers to Africa's participation in multicenter clinical studies and the strategies to eliminate those impedances.

METHODS

The discussions held during the two clinical trial summits were condensed into a set of 10 recommendations covering five broad categories (funding, regulation, capacity building, Africa-centric approach, and patient engagement). In this article, four programs are presented as examples of how the summits' recommendations can be put into practice to improve Africa's ability to attract clinical trials, in particular, cancer clinical trials.

RESULTS

These example programs all leveraged a multilateral, Africa-driven approach to building Africa's clinical trial capacity, increasing visibility of Africa's current clinical trial capabilities and priorities, improving regulatory infrastructure and enforcement on the continent, and optimizing patient and clinician engagement strategies.

CONCLUSION

The four programs are anticipated to catalyze the involvement of more African health care sites in cancer clinical trials, enroll a greater number of African patients with cancer in those trials, and, ultimately, reverse Africa's growing cancer incidence and mortality rates. Each program acts as a blueprint for organizations-whether government, academic, or industry-seeking to address the summits' recommendations and increase Africa's contributions to and active participation in clinical research.

摘要

目的

与长期趋势形成戏剧性逆转的是,如今癌症在非洲造成的死亡人数超过了疟疾。尽管非洲的癌症负担日益加重,但非洲裔个体,尤其是居住在非洲的那些人,在癌症临床试验中的代表性仍然极低。最近的两次峰会——第一届全非洲临床试验峰会和尼日利亚临床试验运营战略峰会——召集了来自政府、私营部门、大学和专业协会的专家,以确定非洲参与多中心临床研究的障碍以及消除这些障碍的策略。

方法

两次临床试验峰会期间的讨论被浓缩为一套涵盖五大类(资金、监管、能力建设、以非洲为中心的方法和患者参与)的10项建议。在本文中,介绍了四个项目,作为峰会建议如何付诸实践以提高非洲吸引临床试验,特别是癌症临床试验能力的示例。

结果

这些示例项目都采用了一种由非洲推动的多边方法,以建设非洲的临床试验能力,提高非洲当前临床试验能力和优先事项的知名度,改善非洲大陆的监管基础设施和执法情况,并优化患者和临床医生参与策略。

结论

预计这四个项目将促使更多非洲医疗保健机构参与癌症临床试验,使更多非洲癌症患者参与这些试验,并最终扭转非洲不断上升的癌症发病率和死亡率。每个项目都为寻求落实峰会建议并增加非洲对临床研究的贡献及积极参与的组织(无论是政府、学术还是行业组织)提供了蓝图。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d28a/7392738/4994134040fd/JGO.19.00204f1.jpg

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