Creating a Framework for Conducting Randomized Clinical Trials during Disease Outbreaks

被引:57
作者
Dean, Natalie E. [1 ]
Gsell, Pierre-Stephane [2 ]
Brookmeyer, Ron [3 ]
Crawford, Forrest W. [4 ]
Donnelly, Christl A. [5 ,7 ]
Ellenberg, Susan S. [10 ]
Fleming, Thomas R. [11 ]
Halloran, M. Elizabeth [11 ,12 ]
Horby, Peter [6 ]
Jaki, Thomas [9 ]
Krause, Philip R. [13 ]
Longini, Ira M. [1 ]
Mulangu, Sabue [15 ]
Muyembe-Tamfum, Jean-Jacques [15 ]
Nason, Martha C. [14 ]
Smith, Peter G. [8 ]
Wang, Rui [16 ,17 ,18 ]
Henao-Restrepo, Ana M. [2 ]
De Gruttola, Victor [18 ]
机构
[1] Univ Florida, Dept Biostat, Gainesville, FL USA
[2] WHO, Geneva, Switzerland
[3] Univ Calif Los Angeles, Dept Biostat, Los Angeles, CA USA
[4] Yale Univ, Dept Biostat, New Haven, CT USA
[5] Univ Oxford, Dept Stat, Oxford, England
[6] Univ Oxford, Ctr Trop Med & Global Hlth, Oxford, England
[7] Imperial Coll London, Dept Infect Dis Epidemiol, Ctr Global Infect Dis Anal, MRC, London, England
[8] London Sch Hyg & Trop Med, MRC Trop Epidemiol Grp, London, England
[9] Univ Lancaster, Dept Math & Stat, Lancaster, England
[10] Univ Penn, Dept Biostat Epidemiol & Informat, Philadelphia, PA 19104 USA
[11] Univ Washington, Dept Biostat, Seattle, WA 98195 USA
[12] Fred Hutchinson Canc Res Ctr, Vaccine & Infect Dis Div, 1124 Columbia St, Seattle, WA 98104 USA
[13] US FDA, Off Vaccines Res & Review, Ctr Biol Evaluat & Res, Silver Spring, MD USA
[14] NIAID, Biostat Res Branch, 9000 Rockville Pike, Bethesda, MD 20892 USA
[15] Inst Natl Rech Biomed, Kinshasa, DEM REP CONGO
[16] Harvard Med Sch, Dept Populat Med, Boston, MA 02115 USA
[17] Harvard Pilgrim Hlth Care Inst, Boston, MA USA
[18] Harvard TH Chan Sch Publ Hlth, Dept Biostat, Boston, MA USA
基金
英国医学研究理事会;
关键词
VACCINE; EBOLA;
D O I
10.1056/NEJMsb1905390
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
As in the ongoing Covid-19 pandemic, global outbreaks of infectious illnesses often develop quickly and resolve in unpredictable ways. In this report, strategies to develop high-quality evidence to guide the development of new therapies are proposed.
引用
收藏
页码:1366 / 1369
页数:4
相关论文
共 13 条
[1]
Drug resistance in malaria, tuberculosis, and HIV in South East Asia: biology, programme, and policy considerations [J].
Panda, Samiran ;
Swaminathan, Soumya ;
Hyder, Khurshid A. ;
Christophel, Eva-Maria ;
Pendse, Razia N. ;
Sreenivas, Achuthan N. ;
Laksono, Setiwan J. ;
Srivastava, Rahul ;
Nair, Gopinath B. ;
Aditama, Tjandra Y. ;
Singhasivanon, Pratap ;
Thapa, Arun B. ;
Sarkar, Swarup K. .
BMJ-BRITISH MEDICAL JOURNAL, 2017, 358 :67-70
[2]
A Randomized, Controlled Trial of ZMapp for Ebola Virus Infection [J].
Davey, Richard T., Jr. ;
Dodd, Lori ;
Proschan, Michael A. ;
Neaton, James ;
Nordwall, Jacquie Neuhaus ;
Koopmeiners, Joseph S. ;
Beigel, John ;
Tierney, John ;
Lane, H. Clifford ;
Fauci, Anthony S. ;
Massaquoi, Moses B. F. ;
Sahr, Foday ;
Malvy, Denis .
NEW ENGLAND JOURNAL OF MEDICINE, 2016, 375 (15) :1448-1456
[3]
Design of vaccine efficacy trials during public health emergencies [J].
Dean, Natalie E. ;
Gsell, Pierre-Stephane ;
Brookmeyer, Ron ;
De Gruttola, Victor ;
Donnelly, Christl A. ;
Halloran, M. Elizabeth ;
Jasseh, Momodou ;
Nason, Martha ;
Riveros, Ximena ;
Watson, Conall H. ;
Henao-Restrepo, Ana Maria ;
Longini, Ira M. .
SCIENCE TRANSLATIONAL MEDICINE, 2019, 11 (499)
[4]
DeMets D L, 1995, Cancer Treat Res, V75, P1
[5]
Data monitoring committees: Promoting best practices to address emerging challenges [J].
Fleming, Thomas R. ;
DeMets, David L. ;
Roe, Matthew T. ;
Wittes, Janet ;
Calis, Karim A. ;
Vora, Amit N. ;
Meisel, Alan ;
Bain, Raymond P. ;
Konstam, Marvin A. ;
Pencina, Michael J. ;
Gordon, David J. ;
Mahaffey, Kenneth W. ;
Hennekens, Charles H. ;
Neaton, James D. ;
Pearson, Gail D. ;
Andersson, Tomas L. G. ;
Pfeffer, Marc A. ;
Ellenberg, Susan S. .
CLINICAL TRIALS, 2017, 14 (02) :115-123
[6]
Grant AM, 2005, HEALTH TECHNOL ASSES, V9, P1
[7]
Implementation of an Ebola virus disease vaccine clinical trial during the Ebola epidemic in Liberia: Design, procedures, and challenges [J].
Kennedy, Stephen B. ;
Neaton, James D. ;
Lane, H. Clifford ;
Kieh, Mark W. S. ;
Massaquoi, Moses B. F. ;
Touchette, Nancy A. ;
Nason, Martha C. ;
Follmann, Dean A. ;
Boley, Fatorma K. ;
Johnson, Melvin P. ;
Larson, Gregg ;
Kateh, Francis N. ;
Nyenswah, Tolbert G. .
CLINICAL TRIALS, 2016, 13 (01) :49-56
[8]
Kieny MP, 2017, LANCET, V389, P2469, DOI 10.1016/S0140-6736(17)31635-5
[9]
Protective efficacy of a live attenuated vaccine against Argentine hemorrhagic fever [J].
Maiztegui, JI ;
McKee, KT ;
Oro, JGB ;
Harrison, LH ;
Gibbs, PH ;
Feuillade, MR ;
Enria, DA ;
Briggiler, AM ;
Levis, SC ;
Ambrosio, AM ;
Halsey, NA ;
Peters, CJ .
JOURNAL OF INFECTIOUS DISEASES, 1998, 177 (02) :277-283
[10]
A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics [J].
Mulangu, Sabue ;
Dodd, Lori E. ;
Davey, Richard T., Jr. ;
Mbaya, Olivier Tshiani ;
Proschan, Michael ;
Mukadi, Daniel ;
Manzo, Mariano Lusakibanza ;
Nzolo, Didier ;
Oloma, Antoine Tshomba ;
Ibanda, Augustin ;
Ali, Rosine ;
Coulibaly, Sinare ;
Levine, Adam C. ;
Grais, Rebecca ;
Diaz, Janet ;
Lane, H. Clifford ;
Muyembe-Tamfum, Jean-Jacques ;
Sivahera, Billy ;
Camara, Modet ;
Kojan, Richard ;
Walker, Robert ;
Dighero-Kemp, Bonnie ;
Cao, Huyen ;
Mukumbayi, Philippe ;
Mbala-Kingebeni, Placide ;
Ahuka, Steve ;
Albert, Sarah ;
Bonnett, Tyler ;
Crozier, Ian ;
Duvenhage, Michael ;
Proffitt, Calvin ;
Teitelbaum, Marc ;
Moench, Thomas ;
Aboulhab, Jamila ;
Barrett, Kevin ;
Cahill, Kelly ;
Cone, Katherine ;
Eckes, Risa ;
Hensley, Lisa ;
Herpin, Betsey ;
Higgs, Elizabeth ;
Ledgerwood, Julie ;
Pierson, Jerome ;
Smolskis, Mary ;
Sow, Ydrissa ;
Tierney, John ;
Sivapalasingam, Sumathi ;
Holman, Wendy ;
Gettinger, Nikki ;
Vallee, David .
NEW ENGLAND JOURNAL OF MEDICINE, 2019, 381 (24) :2293-2303