Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?
Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?
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DOI：
10.1080/15265161.2021.1974975
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发表时间：
2021-10-16
影响因子：
13.4
通讯作者：
Bateman-House, Alison
中科院分区：
文献类型：
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作者：
Lynch, Holly Fernandez;Caplan, Arthur;Bateman-House, Alison
在目睹了为加快新的COVID-19干预措施的开发和获得而做出的非凡科学和监管努力后，面临其他严重疾病的患者开始问：“我们的操作曲速在哪里？”为什么紧急使用授权不是我们健康危机的一种选择？“尽管这场大流行具有许多独特的特点，但对COVID-19的应对措施无论是成功还是失败，都为非大流行性疾病提供了可翻译的经验教训。其中包括跨部门合作的重要性，支持最优先的研究工作，采用严格和创新的试验设计，以及快速共享可靠的信息。此外，监管部门对大流行的反应表明，降低上市许可标准可能导致安全问题增加，错过研究和治疗机会，并推迟确定有效措施。因此，政策制定者和患者倡导者寻求利用COVID-19经验治疗未满足治疗需求的非大流行性疾病，应将工作重点放在促进稳健和有效的研究设计，改善临床试验的可及性，并促进使用食品和药物管理局现有的扩大获取途径。
After witnessing extraordinary scientific and regulatory efforts to speed development of and access to new COVID-19 interventions, patients facing other serious diseases have begun to ask "where's our Operation Warp Speed?" and "why isn't Emergency Use Authorization an option for our health crises?" Although this pandemic bears a number of unique features, the response to COVID-19 offers translatable lessons, in both its successes and failures, for non-pandemic diseases. These include the importance of collaborating across sectors, supporting the highest-priority research efforts, adopting rigorous and innovative trial designs, and sharing reliable information quickly. In addition, the regulatory response to the pandemic demonstrates that lowering standards for marketing authorization can result in increased safety concerns, missed opportunities for research and treatment, and delays in determining what works. Accordingly, policymakers and patient advocates seeking to build on the COVID-19 experience for non-pandemic diseases with unmet treatment needs should focus their efforts on promoting robust and efficient research designs, improving access to clinical trials, and facilitating use of the Food and Drug Administration's existing Expanded Access pathway.