FDA启动“冠状病毒治疗加速计划”（CTAP）， 24小时值班，全力加速新冠疗法的研发

药时代上海报道

随着新冠病毒感染肺炎疫情的日趋严重，呼吁FDA加快新疗法和疫苗研发速度的呼声与日俱增，FDA承受的政治压力不断加大。在这个特殊的时刻，FDA制定了一项紧急计划，以加快新型冠状病毒治疗方法的开发。FDA认为，通过重新调兵遣将，它可以在收到COVID-19相关的要求后的24小时内作出回应，对方案进行审评。

随着COVID-19大流行的升级，越来越多的药物开发商将其资源投入了老药新用和新颖的疗法的开发之中。FDA现在寄希望于10款处于积极试验阶段的药物，以及15款处于计划阶段的药物。为了加速这些产品向前推进的监管流程，FDA正式启动了“冠状病毒治疗加速计划”（Coronavirus Treatment Acceleration Program，CTAP）。

FDA表示，CTAP竭尽全力查明这些疗法是有益还是有害，尽快将新疗法推向患者。实际上，这意味着潜在的COVID-19疗法的开发人员将从FDA的内部通道受益，从而缩短FDA监管过程中多个步骤的等待时间。

在解释CTAP的作用之时，FDA强调了它有能力在24小时内响应开发COVID-19候选药物的申办方的要求。该机构的目标是安排合适的FDA工作人员与申办方取得联系，高效推进。

作为CTAP的实例，FDA在24小时内对研究方案进行审评，以及在3小时内处理单个患者扩大性用药的请求。其它的例子包括加快质量评估以及与公司和其它机构合作将生产转移到新地点以防止供应中断。

FDA回应研发公司的速度到底有多快，部分取决于对候选疗法的前景的评估。具体地说，FDA正在基于产品的科学益处、所处开发阶段和将其确定为潜在的优先产品来安排互动的优先级。

即使对请求进行了分类，CTAP仍需要重新安排FDA资源以根据承诺的周转时间进行交付。FDA已将医学和监管人员重新部署到针对冠状病毒的团队中，委托药物评估和研究中心（CDER）和生物制品评估和研究中心（CBER）的工作人员尽快提供建议、指导和技术援助。

美国卫生与公众服务部（HHS）部长Alex Azar法学博士在一份声明中表示：“FDA正在削减繁文缛节，重新安排工作人员，24小时昼夜工作，以审查致力于发现有效疗法的公司、科学家和医生的要求。”

FDA面临着将新的或现有的疗法送到医生手中以治疗COVID-19患者的压力，特朗普总统和他的律师以及前纽约市市长鲁迪·朱利安尼在上周连连发声，敦促尽快开发现有药物或新药物抗击这场疫情。在这种情况下，CTAP应运而生。

以下为FDA官网的介绍。

Coronavirus Treatment Acceleration Program

(CTAP)

FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (CTAP). It uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. We continue to support clinical trials that are testing new treatments for COVID so that we gain valuable knowledge about their safety and effectiveness.

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Snapshot for Developing Therapeutics

Given the urgent nature of the pandemic and the number of companies and researchers developing COVID-19 related therapies, the following numbers may change frequently. Our current snapshot is:

• 10 therapeutic agents in active trials

• Another 15 therapeutic agents in planning stages

Please send requests for product development for proposed COVID-19 uses and drug development to: [e-mail].  Thank you

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Examples of CTAP in Action

• Immediately upon receipt, triaged requests from developers and scientists seeking to develop or evaluate new drug and biologic therapies, getting the right FDA staff in touch with them and the work to get studies going fast. With a first wave of requests behind us, FDA will generally respond within a day. 

• Provided ultra-rapid, interactive input on most development plans.  Interactions are generally prioritized based on a product’s scientific merits, stage of development, and identification as a possible priority product in consensus USG documents.

• Provided ultra-rapid protocol review – within 24 hours of submission, in many cases.

• Completed review of single patient expanded access requests around-the-clock – and generally within 3 hours.

• Worked closely with applicants and other regulatory agencies to expedite quality assessments for products to treat COVID-19 patients and to transfer manufacturing to alternative or new sites to avoid supply disruption.

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Support for CTAP

• Redeployed medical and regulatory staff to review teams dedicated to COVID-19 therapies.
• Involved senior management in review of submissions.
• Redeployed medical, operations, and policy staff to support the overall effort.
• Streamlined processes and operations for developers and scientists to send us inquiries and requests.
• Provided resources to healthcare providers and researchers to help them submit emergency requests to use investigational products for patients with COVID-19 infections.

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We will continue to enhance and expand CTAP. To the extent permitted by confidentiality laws, we’ll post summary statistics, keep the public updated, and link to public information about ongoing clinical trials and to summaries of drugs in clinical and preclinical development.

药时代将密切关注并即时报道新冠疫情及相应的药品、诊断试剂的批准及使用情况！

参考资料：

• FDA官网：Coronavirus Treatment Acceleration Program (CTAP)

• FDA官网：Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19

• FDA creates program to speed up coronavirustherapies（By  Nick Paul Taylor Apr 1, 20208:21am）

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