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The statistical design and analysis of pandemic platform trials: Implications for the future. 大流行病平台试验的统计设计与分析:对未来的影响。
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.514
Christopher J Lindsell, Matthew Shotwell, Kevin J Anstrom, Scott Berry, Erica Brittain, Frank E Harrell, Nancy Geller, Birgit Grund, Michael D Hughes, Prasanna Jagannathan, Eric Leifer, Carlee B Moser, Karen L Price, Michael Proschan, Thomas Stewart, Sonia Thomas, Giota Touloumi, Lisa LaVange

The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Cross-Trial Statistics Group gathered lessons learned from statisticians responsible for the design and analysis of the 11 ACTIV therapeutic master protocols to inform contemporary trial design as well as preparation for a future pandemic. The ACTIV master protocols were designed to rapidly assess what treatments might save lives, keep people out of the hospital, and help them feel better faster. Study teams initially worked without knowledge of the natural history of disease and thus without key information for design decisions. Moreover, the science of platform trial design was in its infancy. Here, we discuss the statistical design choices made and the adaptations forced by the changing pandemic context. Lessons around critical aspects of trial design are summarized, and recommendations are made for the organization of master protocols in the future.

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Cross-Trial Statistics Group(ACTIV交叉试验统计小组)收集了负责设计和分析11个ACTIV治疗主方案的统计人员的经验教训,以便为当代试验设计提供参考,并为未来的大流行病做好准备。ACTIV 主方案旨在快速评估哪些治疗方法可以挽救生命,让人们远离医院,并帮助他们更快地恢复健康。研究团队最初在不了解疾病自然史的情况下开展工作,因此缺乏设计决策所需的关键信息。此外,平台试验设计科学也处于起步阶段。在此,我们将讨论所做的统计设计选择,以及在不断变化的大流行背景下被迫做出的调整。我们总结了试验设计关键环节的经验教训,并对未来主方案的组织提出了建议。
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引用次数: 0
The future is now: Using the lessons learned from the ACTIV COVID-19 therapeutics trials to create an inclusive and efficient clinical trials enterprise. 未来就是现在:利用从 ACTIV COVID-19 疗法试验中汲取的经验教训,创建一个包容、高效的临床试验企业。
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.622
Stacey J Adam, Sarah E Dunsmore, Lisa H Merck, Sarah W Read, Yves Rosenberg
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引用次数: 0
Engaging communities in therapeutics clinical research during pandemics: Experiences and lessons from the ACTIV COVID-19 therapeutics research initiative. 让社区参与大流行病期间的治疗临床研究:ACTIV COVID-19 疗法研究计划的经验和教训。
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.561
David A Wohl, Stacey J Adam, Kevin W Gibbs, Ari L Moskowitz, Thomas L Ortel, Upinder Singh, Nikolaus Jilg, Teresa H Evering, William A Fischer, Babafemi O Taiwo, Eric S Daar, Christopher J Lindsell, Susanna Naggie, Russell L Rothman, Sarah E Dunsmore, M Patricia McAdams, Julia Vail, Dushyantha Jayaweera

This manuscript addresses a critical topic: navigating complexities of conducting clinical trials during a pandemic. Central to this discussion is engaging communities to ensure diverse participation. The manuscript elucidates deliberate strategies employed to recruit minority communities with poor social drivers of health for participation in COVID-19 trials. The paper adopts a descriptive approach, eschewing analysis of data-driven efficacy of these efforts, and instead provides a comprehensive account of strategies utilized. The Accelerate COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership launched early in the COVID-19 pandemic to develop clinical trials to advance SARS-CoV-2 treatments. In this paper, ACTIV investigators share challenges in conducting research during an evolving pandemic and approaches selected to engage communities when traditional strategies were infeasible. Lessons from this experience include importance of community representatives' involvement early in study design and implementation and integration of well-developed public outreach and communication strategies with trial launch. Centralization and coordination of outreach will allow for efficient use of resources and the sharing of best practices. Insights gleaned from the ACTIV program, as outlined in this paper, shed light on effective strategies for involving communities in treatment trials amidst rapidly evolving public health emergencies. This underscores critical importance of community engagement initiatives well in advance of the pandemic.

这篇手稿探讨了一个重要话题:在大流行病期间开展临床试验的复杂性。讨论的核心是让社区参与进来,确保多元化的参与。手稿阐明了为招募健康社会驱动因素较差的少数民族社区参与 COVID-19 试验而采取的审慎策略。本文采用描述性方法,避免对这些努力的数据驱动效果进行分析,而是全面介绍了所采用的策略。加速 COVID-19 治疗干预和疫苗(ACTIV)公私合作项目在 COVID-19 大流行初期就已启动,旨在开展临床试验以推进 SARS-CoV-2 治疗。在本文中,ACTIV 的研究人员分享了在不断演变的大流行病期间开展研究所面临的挑战,以及在传统策略不可行的情况下为吸引社区参与而选择的方法。从中汲取的经验包括社区代表在研究设计和实施早期参与的重要性,以及将完善的公众宣传和沟通策略与试验启动相结合的重要性。集中和协调外联工作将有助于有效利用资源和分享最佳实践。本文概述了从 ACTIV 计划中获得的启示,揭示了在快速发展的公共卫生紧急情况下让社区参与治疗试验的有效策略。这凸显了在大流行发生之前提前开展社区参与活动的重要性。
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引用次数: 0
ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic. ACTIV 试验:在突发大流行病背景下设计试验的经验教训。
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.1
Maryam Keshtkar-Jahromi, Kevin J Anstrom, Christina Barkauskas, Samuel M Brown, Eric S Daar, William Fischer, Kevin W Gibbs, Elizabeth S Higgs, Michael D Hughes, Prasanna Jagannathan, Lisa LaVange, Christopher J Lindsell, Seema U Nayak, Roger Paredes, Mahesh Parmar, Ithan D Peltan, Michael Proschan, Matthew S Shotwell, David M Vock, Tammy Yokum, Stacey J Adam

Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) was initiated by the US government to rapidly develop and test vaccines and therapeutics against COVID-19 in 2020. The ACTIV Therapeutics-Clinical Working Group selected ACTIV trial teams and clinical networks to expeditiously develop and launch master protocols based on therapeutic targets and patient populations. The suite of clinical trials was designed to collectively inform therapeutic care for COVID-19 outpatient, inpatient, and intensive care populations globally. In this report, we highlight challenges, strategies, and solutions around clinical protocol development and regulatory approval to document our experience and propose plans for future similar healthcare emergencies.

加速 COVID-19 治疗干预和疫苗 (ACTIV) 由美国政府发起,旨在 2020 年快速开发和测试针对 COVID-19 的疫苗和疗法。ACTIV 疗法-临床工作组选择了 ACTIV 试验团队和临床网络,以根据治疗目标和患者群体快速开发和启动主方案。这套临床试验旨在为全球 COVID-19 门诊、住院和重症监护人群的治疗护理提供集体信息。在本报告中,我们重点介绍了临床方案开发和监管审批方面的挑战、策略和解决方案,以记录我们的经验,并为未来类似的医疗紧急情况提出计划。
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引用次数: 0
Preparing better: Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) therapeutics trials lessons learned: A call to the future. 做更好的准备:加速 COVID-19 治疗干预和疫苗(ACTIV)治疗试验的经验教训:对未来的呼唤。
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.178
Stacey J Adam, Timothy G Buchman, Judith S Currier, Ruxandra Draghia-Akli, Josh P Fessel, Elizabeth S Higgs, Eric A Hughes, Lisa LaVange, Joseph P Menetski, Sarah W Read, Yves Rosenberg, Randall Tressler

The Accelerating COVID-19 Therapeutic Interventions and Vaccines Therapeutic-Clinical Working Group members gathered critical recommendations in follow-up to lessons learned manuscripts released earlier in the COVID-19 pandemic. Lessons around agent prioritization, preclinical therapeutics testing, master protocol design and implementation, drug manufacturing and supply, data sharing, and public-private partnership value are shared to inform responses to future pandemics.

加速 COVID-19 治疗干预和疫苗治疗临床工作组成员在 COVID-19 大流行早期发布的经验教训手稿的后续工作中收集了重要建议。他们分享了关于病原体优先排序、临床前治疗测试、主方案设计与实施、药品生产与供应、数据共享和公私合作价值等方面的经验教训,以便为应对未来的大流行提供参考。
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引用次数: 0
Lessons learned from the conduct of inpatient clinical trials in a pandemic. 在大流行病中开展住院病人临床试验的经验教训。
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.483
Jane A O'Halloran, Jeremy R Beitler, Lucy K Chung, Mamta K Jain, Akram Khan, Lisa H Merck, Ahmad Mourad, Minn A Oh, Shweta Sharma, Tammy Yokum, Seema U Nayak

Background: The COVID-19 pandemic amplified known challenges associated with the conduct of inpatient clinical trials, while also introducing new ones that needed to be addressed.

Methods: Stakeholders based in the United States who participated in the conduct of inpatient therapeutic trials for the treatment of COVID-19 as part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines program identified challenges experienced in the conduct of these trials through a series of meeting to discuss and identify common themes. In addition, innovations developed to address these challenges and other potential solutions that may be utilized in future pandemics were highlighted.

Results: Six thematic challenges including infection control considerations, the interplay between provision of clinical care and research, competing clinical trials, arduous consenting procedures, onerous procedural requirements, and participant recruitment including achieving representation of diverse populations were identified and are discussed here.

Conclusions: Consideration of the lessons learned and recommendation outlined here may allow for more efficient conduct of inpatient clinical trials in future pandemics.

背景:COVID-19大流行扩大了与开展住院临床试验相关的已知挑战,同时也引入了需要解决的新挑战:方法:作为 "加速 COVID-19 治疗干预和疫苗计划 "的一部分,参与开展 COVID-19 住院治疗试验的美国利益相关者通过一系列会议讨论和确定共同主题,找出了在开展这些试验过程中遇到的挑战。此外,会议还强调了为应对这些挑战而开发的创新方法,以及可能在未来大流行病中使用的其他潜在解决方案:确定并讨论了六个主题挑战,包括感染控制考虑因素、提供临床护理与研究之间的相互作用、相互竞争的临床试验、艰巨的同意程序、繁琐的程序要求以及参与者招募,包括实现不同人群的代表性:结论:考虑到本文概述的经验教训和建议,可以在未来的大流行病中更有效地开展住院临床试验。
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引用次数: 0
Lessons learned from COVID-19 to overcome challenges in conducting outpatient clinical trials to find safe and effective therapeutics for the next infectious pandemic. 从 COVID-19 中吸取经验教训,克服开展门诊临床试验的挑战,为下一次传染病大流行找到安全有效的治疗方法。
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.607
Minn A Oh, Judith Currier, Akram Khan, Eleftherios Mylonakis, Matthew Newell, Rachel Bender Ignacio, Nick Jilg, Basmah Safdar, Lisa H Merck, Davey M Smith
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引用次数: 0
ACTIV trials: cross-trial lessons learned for master protocol implementation. ACTIV 试验:主协议实施的交叉试验经验教训。
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.507
Maryam Keshtkar-Jahromi, Stacey J Adam, Indira Brar, Lucy K Chung, Judith S Currier, Eric S Daar, Victoria J Davey, Eileen T Denning, Annetine C Gelijns, Elizabeth S Higgs, Prasanna Jagannathan, Arzhang Cyrus Javan, Tomas O Jensen, Nikolaus Jilg, Ioannis Kalomenidis, Peter Kim, Seema U Nayak, Matthew Newell, Babafemi O Taiwo, Tammy Yokum, Yvette Delph

The United States Government (USG) public-private partnership "Accelerating COVID-19 Treatment Interventions and Vaccines" (ACTIV) was launched to identify safe, effective therapeutics to treat patients with Coronavirus Disease 2019 (COVID-19) and prevent hospitalization, progression of disease, and death. Eleven original master protocols were developed by ACTIV, and thirty-seven therapeutic agents entered evaluation for treatment benefit. Challenges encountered during trial implementation led to innovations enabling initiation and enrollment of over 26,000 participants in the trials. While only two ACTIV trials continue to enroll, the recommendations here reflect information from all the trials as of May 2023. We review clinical trial implementation challenges and corresponding lessons learned to inform future therapeutic clinical trials implemented in response to a public health emergency and the conduct of complex clinical trials during "peacetime," as well.

美国政府(USG)发起了 "加速 COVID-19 治疗干预和疫苗"(ACTIV)公私合作项目,旨在确定安全、有效的治疗方法,治疗 2019 年冠状病毒病(COVID-19)患者,防止住院、病情恶化和死亡。ACTIV 制定了 11 项原创主方案,37 种治疗药物进入治疗效益评估。在试验实施过程中遇到的挑战促成了创新,使超过 26,000 名参与者得以启动和加入试验。虽然只有两项 ACTIV 试验仍在继续招募,但本文的建议反映了截至 2023 年 5 月所有试验的信息。我们回顾了临床试验实施过程中遇到的挑战以及相应的经验教训,为今后应对公共卫生突发事件而实施的治疗性临床试验以及在 "和平时期 "开展复杂的临床试验提供参考。
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引用次数: 0
Overview of ACTIV trial-specific lessons learned. ACTIV 试验的具体经验教训概述。
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2023.698
Ruxandra Draghia-Akli, Sarah W Read, Eric A Hughes

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) was an extraordinary example of a public-private partnership (PPP) that brought together over thirty organizations and hundreds of individuals to address one of the most pressing global health needs in recent decades. In particular, ACTIV provided a key avenue for testing numerous therapeutics for their potential benefit in treating the SARS-CoV-2 virus or the resulting symptoms of acute COVID-19 infection. Given the speed and scale at which ACTIV designed and implemented master protocols across global networks that it was simultaneously working to create, the PPP can provide valuable lessons for best practices and avoiding pitfalls the next time the world is faced with a global pandemic of a novel pathogen. This report provides a general overview of the ACTIV partnership to set the stage and context for the subsequent articles in this issue that will relay these lessons learned.

加速 COVID-19 治疗干预和疫苗(ACTIV)是公私合作伙伴关系(PPP)的一个杰出范例,它汇集了三十多个组织和数百名个人,以解决近几十年来最紧迫的全球健康需求之一。特别是,ACTIV 为测试多种治疗方法提供了重要途径,以确定这些方法对治疗 SARS-CoV-2 病毒或急性 COVID-19 感染症状的潜在益处。考虑到 ACTIV 在其同时努力创建的全球网络中设计和实施主协议的速度和规模,PPP 可以为下一次全球面临新型病原体大流行时的最佳实践和避免陷阱提供宝贵的经验。本报告对 ACTIV 合作伙伴关系进行了总体概述,为本期后续文章介绍这些经验教训奠定了基础和背景。
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引用次数: 0
Optimizing external advisory committee meetings of Clinical and Translational Science Awards through focused pre-review. 通过集中预审,优化临床和转化科学奖外部咨询委员会会议。
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-14 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.575
Shannon L Casey, Elizabeth S Burnside, Allan R Brasier

External advisory committees (EACs) are critical peer-review meetings that drive improvement at Clinical and Translational Science Award Program Hubs. Despite their ubiquity, evaluations of EAC optimization and effective implementation remain scarce. We present a two-tiered approach to optimizing EAC meetings through (1) in-depth, topically focused "pre-review" meetings comprised of external topic experts and at least one standing "full-board" EAC member, followed by (2) a traditional "full-board" EAC meeting. This approach allowed pre-review discussion of program-focused topics and specific recommendations, later delivered to the full-board for review and direction. To evaluate this approach, we interviewed 18 people who planned, administered, or attended pre-review and/or full-board meetings, including internal Hub staff, external topic experts, and standing EAC members. Thematic analysis was used to explore planning, implementation, and value of our two-tiered approach versus the traditional single full-board approach. Interviewees preferred the two-tiered approach, noting benefits including additional time to reflect, shared identification of strengths and challenges, and discussion of solutions to share later with the full-board. Those who attended pre-review meetings described building "transformational," rather than "transactional," relationships with invitees through more discussion and inter-hub sharing. That increased sharing invited more exploration, discussion, and planning of next steps toward innovation.

外部咨询委员会(EAC)是推动临床与转化科学奖项目中心改进工作的重要同行评审会议。尽管外部咨询委员会无处不在,但对其优化和有效实施的评估仍然很少。我们介绍了一种优化 EAC 会议的两级方法,即(1)由外部专题专家和至少一名 EAC 常任 "全委会 "成员组成的深入、聚焦专题的 "预审 "会议,以及(2)传统的 EAC "全委会 "会议。这种方法允许对计划重点议题和具体建议进行预审讨论,然后提交全体委员会审查和指导。为了评估这种方法,我们采访了 18 位策划、管理或参加预审和/或全体委员会会议的人员,包括 Hub 内部员工、外部专题专家和 EAC 常任成员。我们采用专题分析法来探讨我们的双层方法与传统的单一全体委员会方法的规划、实施和价值。受访者更倾向于双层方法,他们指出这种方法的好处包括有更多的时间进行反思,共同确定优势和挑战,以及讨论解决方案,以便稍后与全体委员会分享。参加预审会议的受访者表示,通过更多的讨论和枢纽间的交流,他们与受邀者建立起了 "变革性 "而非 "交易性 "的关系。这种分享的增加促使人们进行更多的探索、讨论,并规划下一步的创新措施。
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引用次数: 0
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Journal of Clinical and Translational Science
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