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Adapting to a Pandemic - Conducting Oncology Trials during the SARS-CoV-2 Pandemic

机译:在SARS-COV-2大流行期间适应大流行 - 进行肿瘤学试验

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摘要

The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic has necessitated changes in cancer care delivery as resources are reallocated. Clinical trials and other research activities are inevitably impacted. Start-up activities for new trials may be deferred and recruitment suspended. For patients already enrolled however, there are challenges in continuing treatment on trial. Regulatory bodies have issued guidance on managing dinical trials during the pandemic, including contingency measures for remote study visits, delivery of investigational product, and site monitoring visits. New cancer dinical trial practices during the SARS-CoV-2 pandemic indude new risk assessment strategies, decentralized and remote trial coordination, data collection, and delegation of specific therapeutic activities. This experience could provide evidence of more feasible and cost-effective methods for future clinical trial conduct.
机译:严重的急性呼吸综合征Coronavirus-2(SARS-COV-2)大流行在重新分配资源时已经需要变化癌症护理。 临床试验和其他研究活动不可避免地受到影响。 新试验的启动活动可能会被推迟和招聘暂停。 对于已经注册的患者已经注册,持续治疗试验存在挑战。 监管机构已发出关于在大流行期间管理Dinical试验的指导,包括远程学习访问,调查产品提供的应急措施和现场监测访问。 在SARS-COV-2大流行期间新的癌症Dinal试验实践是新的风险评估策略,分散和远程试验协调,数据收集和特定治疗活动的代表团。 这种经验可以为未来的临床试验行为提供更可行和经济高效的方法。

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