新冠肺炎-19大流行病是改变药物开发的机会

Q4 Medicine
T. Ishibashi, Michiyo Ohshima, Takayuki Imaeda, Norisuke Kawai
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引用次数: 0

摘要

新冠肺炎疫情对我们社会的影响是巨大的。为了在大流行期间和之后继续向社会提供新的治疗选择,应利用这一时期获得的经验和想法来改变药物开发。需要在行业内部以及与世界各地卫生当局进行合作,现在是开始对话的时候了。为了促进转型,必须部署基于高道德标准和科学严谨性的方法,优先考虑研究参与者的安全,并确保可交付成果的透明度和质量。此外,需要广泛接受患者和公众的参与,以促进对药物开发的理解,并使患者和家庭成员能够积极参与。为了继续取得对社会产生积极影响的突破,需要利用数字工具并提高其可靠性,应用模型知情的药物开发和现实世界数据,改进监管程序,持续协调监管,以及公司和卫生当局之间的合作。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
COVID‒19 Pandemic as an Opportunity to Transform Drug Development
The impact of COVID-19 on our society is significant. To continue to offer new treatment options to society during and after the pandemic, experiences and ideas gained during this period should be utilized to transform drug development. Collaboration within the industry and with health authorities across the world is required, and now is the time to start the dialogue. To promote transformation, deploying methodologies based on high ethical standards and scientific rigor, prioritizing the safety of study participants, and securing transparency and the quality of deliverables are essential. In addition, broad acceptance of patient and public involvement is needed to promote understanding of drug development and to enable proactive participation of patients and family members. Utilization of digital tools and improving their reliability, the application of model informed drug development and real world data, improvement of regulatory procedures, continuous regulatory harmonization, and collaboration among companies and health authorities are required to continue to deliver breakthroughs that have a positive impact on society.
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CiteScore
0.20
自引率
0.00%
发文量
28
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