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神经肿瘤学临床试验国际合作的障碍和潜在解决方案:来自澳大利亚的挑战。

Barriers and potential solutions to international collaboration in neuro-oncology clinical trials: Challenges from the Australian perspective.

机构信息

Cooperative Trials Group for Neuro-Oncology, National Health and Medical Research Council Clinical Trials Centre, Sydney, Australia.

Faculty of Medicine and Health, University of Sydney, Sydney, Australia.

出版信息

Asia Pac J Clin Oncol. 2022 Jun;18(3):259-266. doi: 10.1111/ajco.13606. Epub 2021 Jun 24.

DOI:10.1111/ajco.13606
PMID:34166569
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9292370/
Abstract

AIM

The neuro-oncology community in Australia is well positioned to collaborate internationally, with a motivated trials group, strong regulatory bodies and an attractive fiscal environment. We sought to identify gaps in the Australian neuro-oncology clinical trials landscape and describe strategies to increase international trial access in Australia.

METHODS

We searched clinical trial registries to identify active adult primary brain cancer trials. We compared the participation rate and phase of these trials between tumour types and countries. A survey was distributed to the Cooperative Trials Group for Neuro-Oncology membership to identify barriers and solutions to effective international collaboration.

RESULTS

Globally, 307 trials for adult primary brain cancers were identified. These included 50% pharmaceutical agents, 18% cellular therapies and 9% radiation therapy. Twelve adult primary brain cancer trials were actively recruiting in Australia at the time the survey was sent out. There were more early phase brain cancer trials (34%) compared with colorectal and breast cancer (21% and 24%, respectively). In Australia, 92% of brain cancer trials were involving pharmaceutical agents. The most commonly cited barrier was lack of funding for international trials (86%) and insufficient research time (75%). High ranking solutions included increasing the availability of funding for international trials and creating opportunities to develop personal relationships with collaborators. Accreditation of clinical research key performance indicators into practice (88%) and hospital accreditation (73%) also ranked highly.

CONCLUSIONS

Participation in international research in Australia could be improved by embedding clinical research targets into institutional funding, provision of funding for early phase studies and streamlining mutual ethics schemes.

摘要

目的

澳大利亚的神经肿瘤学界具有很好的国际合作潜力,拥有积极的试验组、强大的监管机构和有吸引力的财政环境。我们旨在确定澳大利亚神经肿瘤学临床试验领域的差距,并描述增加澳大利亚国际试验机会的策略。

方法

我们在临床试验注册处搜索了成人原发性脑癌的活跃试验。我们比较了肿瘤类型和国家之间这些试验的参与率和阶段。向神经肿瘤合作试验组的成员分发了一项调查,以确定有效国际合作的障碍和解决方案。

结果

全球共确定了 307 项成人原发性脑癌试验。这些试验包括 50%的药物制剂、18%的细胞疗法和 9%的放射疗法。在调查发出时,澳大利亚有 12 项成人原发性脑癌试验正在招募。早期脑癌试验(34%)多于结直肠癌和乳腺癌(分别为 21%和 24%)。在澳大利亚,92%的脑癌试验涉及药物制剂。最常被引用的障碍是缺乏国际试验资金(86%)和研究时间不足(75%)。排名较高的解决方案包括增加国际试验资金的可用性,并为与合作者建立个人关系创造机会。将临床研究主要绩效指标纳入实践的认证(88%)和医院认证(73%)也排名较高。

结论

通过将临床研究目标纳入机构资金、为早期研究提供资金以及简化相互的伦理计划,可以提高澳大利亚参与国际研究的水平。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f031/9292370/b66f0065bd67/AJCO-18-259-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f031/9292370/d545aa071faf/AJCO-18-259-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f031/9292370/7b4d157cc0d4/AJCO-18-259-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f031/9292370/02ce3f0b0459/AJCO-18-259-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f031/9292370/b66f0065bd67/AJCO-18-259-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f031/9292370/d545aa071faf/AJCO-18-259-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f031/9292370/7b4d157cc0d4/AJCO-18-259-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f031/9292370/02ce3f0b0459/AJCO-18-259-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f031/9292370/b66f0065bd67/AJCO-18-259-g003.jpg

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