Clinical trial design during and beyond the pandemic: the I-SPY COVID trial

被引：13

作者：

Calfee, Carolyn S. ^{[1
]}

Liu, Kathleen D.

Asare, Adam L.

Beitler, Jeremy R. ^{[1
]}

Berger, Paul A., III ^{[1
]}

Coleman, Melissa H. ^{[2
]}

Crippa, Alessio ^{[3
]}

Discacciati, Andrea ^{[4
]}

Eklund, Martin ^{[1
]}

Files, Daniel C. ^{[5
]}

Gandotra, Sheetal ^{[5
]}

Gibbs, Kevin W. ^{[5
]}

Henderson, Paul ^{[6
]}

Levitt, Joseph E. ^{[7
]}

Lu, Ruixiao ^{[6
]}

Matthay, Michael A. ^{[2
]}

Meyer, Nuala J. ^{[8
]}

Russell, Derek W. ^{[2
]}

Thomas, Karl W. ^{[1
]}

Esserman, Laura J. ^{[9
]}

Mittel, Aaron M. ^{[7
]}

Dzierba, Amy L. ^{[6
]}

Madahar, Purnema ^{[1
]}

Serra, Alexis L. ^{[3
]}

Rosen, Amanda ^{[10
]}

Garcia, Ivan ^{[11
]}

Muir, Justin ^{[3
]}

Schicchi, John ^{[3
]}

Darmanian, Anita ^{[3
]}

Wahab, Romina ^{[10
]}

Gosek, Katarzyna ^{[3
]}

Auld, Sara C. ^{[3
]}

Adelman, Max W. ^{[3
]}

Nugent, Katherine L. ^{[10
]}

Harris, Gavin H. ^{[12
]}

Creel-Bulos, Christina ^{[12
]}

Yang, Philip ^{[12
]}

Detelich, Joshua F. ^{[12
]}

Spainhour, Christine ^{[12
]}

Cobb, Nathan K. ^{[12
]}

Sonti, Rajiv ^{[12
]}

Orr, Lindsey A. ^{[12
]}

Robinson, Philip A. ^{[13
]}

Sarafian, Farjad ^{[13
]}

Martinez, Esmeralda ^{[13
]}

Jones, Patrice ^{[14
]}

Nguyen, Julie ^{[14
]}

Obermiller, Timothy F. ^{[14
]}

Weiler-Lisowski, Bethany ^{[14
]}

Kufa, Lucia ^{[14
]}

机构：

[1] Univ Calif San Francisco, Francisco, CA USA

[2] QuantumLeap Healthcare Collaborat, Francisco, CA USA

[3] Columbia Univ, Irving Med Ctr, New York, NY USA

[4] Sanford Med Ctr, Sioux Falls, SD USA

[5] Karolinska Inst, Stockholm, Sweden

[6] Wake Forest Baptist Hlth, Winston Salem, NC USA

[7] Univ Alabama Birmingham, Birmingham, AL USA

[8] Stanford Healthcare, Stanford, CA USA

[9] Univ Penn, Perelman Sch Med, Philadelphia, PA USA

[10] New York Presbyterian Hosp, New York, NY USA

[11] Columbia Univ, Coll Physicians & Surg, New York, NY USA

[12] Emory Univ, Atlanta, GA USA

[13] Med Georgetown Univ Hosp, Washington, DC USA

[14] Hoag Mem Hosp, Long Beach, CA USA

[15] Logan Hlth Res Inst, Kalispell, MT USA

[16] Long Beach Med Ctr, Long Beach, CA USA

[17] Lankenau Inst Med Res, Wynnewood, PA USA

[18] Montefiore Med Ctr, New York, NY USA

[19] Albert Einstein Coll Med, New York, NY USA

[20] Northwestern Univ, Feinberg Sch Med, Chicago, IL USA

[21] Univ Calif Davis, Sacramento, CA USA

[22] Univ Calif Irvine, Orange, CA USA

[23] Univ Colorado, Sch Med, Aurora, CO USA

[24] Univ Penn, Philadelphia, PA USA

[25] Kaiser Permanente Southern Calif Physicians Grp, Los Angeles, CA USA

[26] USC, Keck Sch Med, Los Angeles, CA USA

[27] Univ Southern Calif, Los Angeles, CA USA

[28] Yale Sch Med, Haven, CT USA

来源：

NATURE MEDICINE | 2022年 / 28卷 / 01期

关键词：

D O I：

10.1038/s41591-021-01617-x

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

引用

页码：9 / 11

页数：3

共 9 条

[1] Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19 The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial [J].

Angus, Derek C. ;

Derde, Lennie ;

Al-Beidh, Farah ;

Annane, Djillali ;

Arabi, Yaseen ;

Beane, Abigail ;

Van Bentum-Puijk, Wilma ;

Berry, Lindsay ;

Bhimani, Zahra ;

Bonten, Marc ;

Bradbury, Charlotte ;

Brunkhorst, Frank ;

Buxton, Meredith ;

Buzgau, Adrian ;

Cheng, Allen C. ;

de Jong, Menno ;

Detry, Michelle ;

Estcourt, Lise ;

Fitzgerald, Mark ;

Goossens, Herman ;

Green, Cameron ;

Haniffa, Rashan ;

Higgins, Alisa M. ;

Horvat, Christopher ;

Hullegie, Sebastiaan J. ;

Kruger, Peter ;

Lamontagne, Francois ;

Lawler, Patrick R. ;

Linstrum, Kelsey ;

Litton, Edward ;

Lorenzi, Elizabeth ;

Marshall, John ;

McAuley, Daniel ;

McGlothin, Anna ;

McGuinness, Shay ;

McVerry, Bryan ;

Montgomery, Stephanie ;

Mouncey, Paul ;

Murthy, Srinivas ;

Nichol, Alistair ;

Parke, Rachael ;

Parker, Jane ;

Rowan, Kathryn ;

Sanil, Ashish ;

Santos, Marlene ;

Saunders, Christina ;

Seymour, Christopher ;

Turner, Anne ;

van de Veerdonk, Frank ;

Venkatesh, Balasubramanian .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2020, 324 (13) :1317-1329

[2] The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study Rationale and Design [J].

Angus, Derek C. ;

Berry, Scott ;

Lewis, Roger J. ;

Al-Beidh, Farah ;

Arabi, Yaseen ;

van Bentum-Puijk, Wilma ;

Bhimani, Zahra ;

Bonten, Marc ;

Broglio, Kristine ;

Brunkhorst, Frank ;

Cheng, Allen C. ;

Chiche, Jean-Daniel ;

De Jong, Menno ;

Detry, Michelle ;

Goossens, Herman ;

Gordon, Anthony ;

Green, Cameron ;

Higgins, Alisa M. ;

Hullegie, Sebastiaan J. ;

Kruger, Peter ;

Lamontagne, Francois ;

Litton, Edward ;

Marshall, John ;

McGlothlin, Anna ;

McGuinness, Shay ;

Mouncey, Paul ;

Murthy, Srinivas ;

Nichol, Alistair ;

O'Neill, Genevieve K. ;

Parke, Rachael ;

Parker, Jane ;

Rohde, Gernot ;

Rowan, Kathryn ;

Turner, Anne ;

Young, Paul ;

Derde, Lennie ;

McArthur, Colin ;

Webb, Steven A. .

ANNALS OF THE AMERICAN THORACIC SOCIETY, 2020, 17 (07) :879-891

[3] I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy [J].

Barker, A. D. ;

Sigman, C. C. ;

Kelloff, G. J. ;

Hylton, N. M. ;

Berry, D. A. ;

Esserman, L. J. .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2009, 86 (01) :97-100

[4] I-SPY 2-Toward More Rapid Progress in Breast Cancer Treatment [J].

Carey, Lisa A. ;

Winer, Eric P. .

NEW ENGLAND JOURNAL OF MEDICINE, 2016, 375 (01) :83-84

[5] I-SPY 2-A Glimpse of the Future of Phase 2 Drug Development? [J].

Harrington, David ;

Parmigiani, Giovanni .

NEW ENGLAND JOURNAL OF MEDICINE, 2016, 375 (01) :7-9

[6] Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial [J].

Horby, P. W. ;

Roddick, A. ;

Spata, E. ;

Staplin, N. ;

Emberson, J. ;

Pessoa-Amorim, G. ;

Brightling, C. ;

Prudon, B. ;

Chadwick, D. ;

Ustianowski, A. ;

Ashish, A. ;

Todd, S. ;

Yates, B. ;

Buttery, R. ;

Scott, S. ;

Maseda, D. ;

Baillie, J. K. ;

Buch, M. ;

Chappell, L. ;

Day, J. ;

Faust, S. N. ;

Jaki, T. ;

Jeffery, K. ;

Juszczak, E. ;

Lim, W. S. ;

Montgomery, A. ;

Mumford, A. ;

Rowan, K. ;

Thwaites, G. ;

Mafham, M. ;

Haynes, R. ;

Landray, M. J. ;

Horby, P. W. ;

Landray, M. J. ;

Baillie, J. K. ;

Buch, M. ;

Chappell, L. ;

Day, J. ;

Faust, S. N. ;

Haynes, R. ;

Jaki, T. ;

Jeffery, K. ;

Juszczak, E. ;

Lim, W. S. ;

Mafham, M. ;

Montgomery, A. ;

Mumford, A. ;

Rowan, K. ;

Thwaites, G. ;

Sandercock, P. .

LANCET, 2021, 397 (10274) :605-612

[7]

Horby P, 2021, NEW ENGL J MED, V384, P693, DOI [10.1056/NEJMoa2021436, 10.1056/NEJMoa2022926]

[8] Lopinavir-ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial [J].

Horby, Peter W. ;

Landray, Martin J. ;

Mafham, Marion ;

Bell, Jennifer L. ;

Linsell, Louise ;

Staplin, Natalie ;

Emberson, Jonathan R. ;

Palfreeman, Adrian ;

Raw, Jason ;

Elmahi, Einas ;

Prudon, Benjamin ;

Green, Christopher ;

Carley, Simon ;

Chadwick, David ;

Davies, Matthew ;

Wise, Matthew P. ;

Baillie, J. Kenneth ;

Chappell, Lucy C. ;

Faust, Saul N. ;

Jaki, Thomas ;

Jeffery, Katie ;

Lim, Wei Shen ;

Montgomery, Alan ;

Rowan, Kathryn ;

Juszczak, Edmund ;

Haynes, Richard .

LANCET, 2020, 396 (10259) :1345-1352

[9] Prevalence of phenotypes of acute respiratory distress syndrome in critically ill patients with COVID-19 a prospective observational study [J].

Sinha, Pratik ;

Calfee, Carolyn S. ;

Cherian, Shiney ;

Brealey, David ;

Cutler, Sean ;

King, Charles ;

Killick, Charlotte ;

Richards, Owen ;

Cheema, Yusuf ;

Bailey, Catherine ;

Reddy, Kiran ;

Delucchi, Kevin L. ;

Shankar-Hari, Manu ;

Gordon, Anthony C. ;

Shyamsundar, Murali ;

O'Kane, Cecilia M. ;

McAuley, Daniel F. ;

Szakmany, Tamas .

LANCET RESPIRATORY MEDICINE, 2020, 8 (12) :1209-1218

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