A response adaptive randomization platform trial for efficient evaluation of Ebola virus treatments: A model for pandemic response.
A response adaptive randomization platform trial for efficient evaluation of Ebola virus treatments: A model for pandemic response.
复制标题
DOI：
10.1177/1740774515621721
复制
发表时间：
2016-02
期刊：
影响因子：
--
通讯作者：
Woods CW
中科院分区：
文献类型：
--
作者：
Berry SM;Petzold EA;Dull P;Thielman NM;Cunningham CK;Corey GR;McClain MT;Hoover DL;Russell J;Griffiss JM;Woods CW
西非爆发的埃博拉病毒病（EVD）是有史以来最大的一次。已经考虑了多种埃博拉病毒病的治疗方案，包括广泛使用的重新用途药物，但临床试验的开始登记受到限制。提出的试验是一种自适应平台设计。将同时研究多种药物和组合。此外，新的代理可以在可用时进入试验，而失败的代理可能会被删除。为了适应许多可能的药物和组合，该设计的一个关键特征是使用反应自适应随机化来分配治疗方案。随着试验的进展，随机化比例逐渐倾向于表现较好的组，使该设计也适用于全因大流行防备计划。这项研究得到了美国和塞拉利昂伦理委员会的批准，并由美国食品和药物管理局进行了审查。此外，还准备了数据管理、药品供应线和当地站点。然而，为了应对2015年2月出现的流行病下降，没有启动该试验。塞拉利昂仍然准备在埃博拉病毒病死灰复燃的情况下迅速启动该议定书，作为应急试验。总之，我们设计了一项单一对照试验，能够在快速发展的EVD建议治疗方案列表中有效地识别出高效或无效的方案，并根据累积的数据有效地治疗试验中的患者。提供这些治疗方案，如果发现安全有效，将通过提供有效的治疗方案，对未来的流行病产生重大影响。
The outbreak of Ebola Virus Disease (EVD) in West Africa is the largest ever recorded. Numerous treatment alternatives for EVD have been considered, including widely available re-purposed drugs, but initiation of enrollment into clinical trials has been limited. The proposed trial is an adaptive platform design. Multiple agents and combinations will be investigated simultaneously. Additionally, new agents may enter the trial as they become available, and failing agents may be removed. In order to accommodate the many possible agents and combinations, a critical feature of this design is the use of response adaptive randomization to assign treatment regimens. As the trial progresses, the randomization ratio evolves to favor the arms that are performing better, making the design also suitable for all-cause pandemic preparedness planning. The study was approved by US and Sierra Leone ethics committees, and reviewed by the US FDA. Additionally, data management, drug supply lines, and local sites were prepared. However, in response to the declining epidemic seen in February 2015, the trial was not initiated. Sierra Leone remains ready to rapidly activate the protocol as an emergency response trial in the event of a resurgence of EVD. (ClinicalTrials.gov Identifier: NCT02380625) In summary, we have designed a single controlled trial capable of efficiently identifying highly effective or failing regimens among a rapidly evolving list of proposed therapeutic alternatives for EVD and to treat the patients within the trial effectively based on accruing data. Provision of these regimens, if found safe and effective, would have a major impact on future epidemics by providing effective treatment options.
登录
查看更多内容
DOI：
10.1056/nejmoa1411100
发表时间：
2014-10-16
期刊：
The New England journal of medicine
影响因子：
--
作者：
WHO Ebola Response Team;Aylward B;Barboza P;Bawo L;Bertherat E;Bilivogui P;Blake I;Brennan R;Briand S;Chakauya JM;Chitala K;Conteh RM;Cori A;Croisier A;Dangou JM;Diallo B;Donnelly CA;Dye C;Eckmanns T;Ferguson NM;Formenty P;Fuhrer C;Fukuda K;Garske T;Gasasira A;Gbanyan S;Graaff P;Heleze E;Jambai A;Jombart T;Kasolo F;Kadiobo AM;Keita S;Kertesz D;Koné M;Lane C;Markoff J;Massaquoi M;Mills H;Mulba JM;Musa E;Myhre J;Nasidi A;Nilles E;Nouvellet P;Nshimirimana D;Nuttall I;Nyenswah T;Olu O;Pendergast S;Perea W;Polonsky J;Riley S;Ronveaux O;Sakoba K;Santhana Gopala Krishnan R;Senga M;Shuaib F;Van Kerkhove MD;Vaz R;Wijekoon Kannangarage N;Yoti Z
通讯作者：
Yoti Z
在资源受限的环境中使用埃博拉疗养血浆来治疗埃博拉病毒疾病：该领域的视角。
DOI：
10.1093/cid/civ680
发表时间：
2016-01-01
期刊：
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
影响因子：
--
作者：
van Griensven J;De Weiggheleire A;Delamou A;Smith PG;Edwards T;Vandekerckhove P;Bah EI;Colebunders R;Herve I;Lazaygues C;Haba N;Lynen L
通讯作者：
Lynen L
影响因子：
7.6
作者：
Furuta, Yousuke;Gowen, Brian B.;Takahashi, Kazumi;Shiraki, Kimiyasu;Smee, Donald F.;Barnard, Dale L.
通讯作者：
Barnard, Dale L.
影响因子：
39.2
作者：
Liddell AM;Davey RT Jr;Mehta AK;Varkey JB;Kraft CS;Tseggay GK;Badidi O;Faust AC;Brown KV;Suffredini AF;Barrett K;Wolcott MJ;Marconi VC;Lyon GM 3rd;Weinstein GL;Weinmeister K;Sutton S;Hazbun M;Albariño CG;Reed Z;Cannon D;Ströher U;Feldman M;Ribner BS;Lane HC;Fauci AS;Uyeki TM
通讯作者：
Uyeki TM
DOI：
10.1128/genomea.00639-15
发表时间：
2015-05-01
期刊：
GENOME ANNOUNCEMENTS
影响因子：
--
作者：
Castilletti, Concetta;Carletti, Fabrizio;Capobianchi, Maria R.
通讯作者：
Capobianchi, Maria R.