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国际肿瘤学试验合作的挑战——行动呼吁。

Challenges of international oncology trial collaboration-a call to action.

机构信息

NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.

Department of Oncology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.

出版信息

Br J Cancer. 2019 Oct;121(7):515-521. doi: 10.1038/s41416-019-0532-4. Epub 2019 Aug 5.

Abstract

International collaboration in oncology trials has the potential to enhance clinical trial activity by expediting the recruitment of large patient populations, testing treatments in diverse populations and facilitating the study of rare tumours or specific molecular subtypes. However, a number of challenges continue to hinder the efficient and productive conduct of both commercial and non-commercial international clinical trials. These challenges include complex and burdensome regulatory requirements, the high cost of conducting trials, and logistical challenges associated with ethics review, drug supply and biospecimen collection and management. We propose solutions to promote oncology trial collaboration, such as regulatory reform, harmonisation of trial initiation and management processes and greater recognition and funding of academic (non-commercial) clinical trials. It is only through coordinated effort and leadership from researchers, regulators and those responsible for health systems that the full potential of international trial collaboration can be realised.

摘要

肿瘤学临床试验的国际合作具有通过加速招募大量患者人群、在不同人群中测试治疗方法以及促进罕见肿瘤或特定分子亚型研究的潜力。然而,一些挑战仍然阻碍着商业和非商业性国际临床试验的高效和富有成效的开展。这些挑战包括复杂且繁重的监管要求、试验开展的高成本,以及与伦理审查、药物供应以及生物样本采集和管理相关的后勤挑战。我们提出了一些解决方案,以促进肿瘤学试验的合作,例如监管改革、试验启动和管理流程的协调以及对学术(非商业性)临床试验的更多认可和资助。只有通过研究人员、监管机构和负责卫生系统的人员的协调努力和领导,才能充分发挥国际试验合作的潜力。

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