Impediments to Clinical Research in the United States
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作者:
Kramer, J. M.
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Duke Univ, Med Ctr, Dept Med, Durham, NC 27710 USA
Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC 27710 USA
Duke Univ, Med Ctr, Duke Translat Med Inst, Durham, NC 27710 USADuke Univ, Med Ctr, Dept Med, Durham, NC 27710 USA
Kramer, J. M.
[1
,2
,3
]
Smith, P. B.
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Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC 27710 USA
Duke Univ, Med Ctr, Duke Translat Med Inst, Durham, NC 27710 USA
Duke Univ, Med Ctr, Dept Pediat, Durham, NC 27710 USADuke Univ, Med Ctr, Dept Med, Durham, NC 27710 USA
Smith, P. B.
[2
,3
,4
]
Califf, R. M.
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Duke Univ, Med Ctr, Dept Med, Durham, NC 27710 USA
Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC 27710 USA
Duke Univ, Med Ctr, Duke Translat Med Inst, Durham, NC 27710 USADuke Univ, Med Ctr, Dept Med, Durham, NC 27710 USA
Califf, R. M.
[1
,2
,3
]
机构:
[1] Duke Univ, Med Ctr, Dept Med, Durham, NC 27710 USA
[2] Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC 27710 USA
[3] Duke Univ, Med Ctr, Duke Translat Med Inst, Durham, NC 27710 USA
[4] Duke Univ, Med Ctr, Dept Pediat, Durham, NC 27710 USA
Clinical trials are essential to the evaluation of promising scientific discoveries, but they are becoming unsustainably burdensome, threatening to deprive patients and health-care providers of new therapies and new evidence to guide the use of existing treatments. Regulations are often blamed for impeding clinical research, but there are other elements of the clinical trials enterprise that also have the potential to add burdens, through either imposed requirements or incentives that do not favor clinical research (Figure 1).(1-3)
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Seattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USASeattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Hather, Gregory J.
Haynes, Winston
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Seattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Hendrix Coll, Conway, AR USASeattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Haynes, Winston
Higdon, Roger
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Seattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Seattle Childrens Hosp, Seattle, WA USASeattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Higdon, Roger
Kolker, Natali
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Seattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Seattle Childrens Hosp, Seattle, WA USASeattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Kolker, Natali
Stewart, Elizabeth A.
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Stewart, Elizabeth A.
Arzberger, Peter
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Seattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Univ Calif San Diego, Ctr Res BioSyst, San Diego, CA 92103 USASeattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Arzberger, Peter
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Chain, Patrick
Field, Dawn
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NERC, Ctr Ecol & Hydrol, Oxford, EnglandSeattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Field, Dawn
Franza, B. Robert
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MYOONET Inc, Seattle, WA USA
Univ Washington, Dept Bioengn, Seattle, WA 98195 USASeattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Franza, B. Robert
Lin, Biaoyang
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Zhejiang Univ, Zhejiang California Int Nanosyst Inst, Hangzhou 310003, Zhejiang, Peoples R China
Swedish Med Ctr, Swedish Neurosci Inst, Seattle, WA USA
Univ Washington, Dept Urol, Seattle, WA 98195 USASeattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Lin, Biaoyang
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Meyer, Folker
Ozdemir, Vural
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McGill Univ, Fac Med, Dept Human Genet, Montreal, PQ, CanadaSeattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Ozdemir, Vural
Smith, Charles V.
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Seattle Childrens Res Inst, Ctr Dev Therapeut, Seattle, WA USA
Univ Washington, Dept Pediat, Seattle, WA 98195 USASeattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Smith, Charles V.
van Belle, Gerald
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Univ Washington, Dept Biostat, Seattle, WA 98195 USA
Univ Washington, Dept Environm & Occupat Hlth Sci, Seattle, WA 98195 USASeattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
van Belle, Gerald
Wooley, John
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Univ Calif San Diego, Ctr Res BioSyst, San Diego, CA 92103 USASeattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Wooley, John
Kolker, Eugene
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Seattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
Seattle Childrens Hosp, Seattle, WA USA
Univ Washington, Dept Med Educ & Biomed Informat, Seattle, WA 98195 USASeattle Childrens Res Inst, Bioinformat & High Throughput Anal Lab, Seattle, WA USA
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Univ Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USAUniv Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USA
Wu, Elizabeth
Wang, Tianyi
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Univ Michigan, Sch Med, Ann Arbor, MI USAUniv Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USA
Wang, Tianyi
Lin, Tammy
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Univ Michigan, Sch Med, Ann Arbor, MI USAUniv Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USA
Lin, Tammy
Chen, Xisui
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Univ Michigan, Sch Med, Ann Arbor, MI USAUniv Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USA
Chen, Xisui
Guan, Zhe
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Univ Michigan, Sch Med, Ann Arbor, MI USAUniv Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USA
Guan, Zhe
Cao, Claudia
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Univ Michigan, Sch Med, Ann Arbor, MI USAUniv Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USA
Cao, Claudia
Rao, Huiying
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Peking Univ, Hlth Sci Ctr, Peoples Hosp, Inst Hepatol, Beijing 100871, Peoples R ChinaUniv Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USA
Rao, Huiying
Yang, Ming
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Peking Univ, Hlth Sci Ctr, Peoples Hosp, Inst Hepatol, Beijing 100871, Peoples R ChinaUniv Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USA
Yang, Ming
Feng, Bo
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Peking Univ, Hlth Sci Ctr, Peoples Hosp, Inst Hepatol, Beijing 100871, Peoples R ChinaUniv Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USA
Feng, Bo
Pui, Sandra
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Univ Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USAUniv Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USA
Pui, Sandra
Chan, Melvin
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Univ Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USAUniv Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USA
Chan, Melvin
Fu, Sherry
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Univ Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USAUniv Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USA
Fu, Sherry
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Lin, Andy
Wei, Lai
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Peking Univ, Hlth Sci Ctr, Peoples Hosp, Inst Hepatol, Beijing 100871, Peoples R ChinaUniv Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USA
Wei, Lai
Lok, Anna S.
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Univ Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USAUniv Michigan, Div Gastroenterol & Hepatol, Ann Arbor, MI 48109 USA
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Rutgers New Jersey Med Sch, Dept Neurol Surg, Newark, NJ USARutgers New Jersey Med Sch, Dept Neurol Surg, Newark, NJ USA
Vought, Rita
Vought, Victoria
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Vought, Victoria
Sames, Antonia
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Sames, Antonia
Shah, Shrey
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Herzog, Ava
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Liu, James K.
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NYU Langone Neurosurg Network, Skull Base Inst New Jersey, Livingston, NJ USA
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Ctr Dis Control & Prevent CDC, DHAP, Natl Ctr HIV AIDS Viral Hepatitis STD & TB Preven, Atlanta, GA USACtr Dis Control & Prevent CDC, DHAP, Natl Ctr HIV AIDS Viral Hepatitis STD & TB Preven, Atlanta, GA USA
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Glassman, Marlene
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Carey, James W.
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Viall, Abigail H.
Purcell, David W.
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Clin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Natl Canc Res Network Coordinating Ctr, Leeds, W Yorkshire, EnglandClin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Stead, M.
Cameron, D.
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Clin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Natl Canc Res Network Coordinating Ctr, Leeds, W Yorkshire, England
Univ Edinburgh, Dept Oncol, Edinburgh, Midlothian, ScotlandClin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Cameron, D.
Lester, N.
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Lester, N.
Parmar, M.
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Natl Canc Res Network Coordinating Ctr, London, England
MRC, Clin Trials Unit, London, EnglandClin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Parmar, M.
Haward, R.
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Natl Canc Res Network Coordinating Ctr, Leeds, W Yorkshire, EnglandClin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Haward, R.
Kaplan, R.
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Natl Canc Res Network Coordinating Ctr, Leeds, W Yorkshire, EnglandClin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Kaplan, R.
Maughan, T.
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Cardiff Univ, Sch Med, Cardiff, S Glam, Wales
Wales Canc Trials Network Coordinating Ctr, Cardiff, S Glam, WalesClin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Maughan, T.
Wilson, R.
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N Ireland Canc Clin Trials Unit, Belfast, Antrim, North IrelandClin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Wilson, R.
Campbell, H.
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Campbell, H.
Hamilton, R.
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Hamilton, R.
Stewart, D.
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Clin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Natl Canc Res Inst, London, EnglandClin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Stewart, D.
O'Toole, L.
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Arthrit Res UK, London, EnglandClin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
O'Toole, L.
Kerr, D.
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Univ Oxford, Dept Clin Pharmacol, Oxford, England
Natl Translat Canc Res Network, Oxford, EnglandClin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Kerr, D.
Potts, V.
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Clin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, EnglandClin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Potts, V.
Moser, R.
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Natl Canc Res Network Coordinating Ctr, Leeds, W Yorkshire, EnglandClin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Moser, R.
Darbyshire, J.
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Clin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
MRC, Clin Trials Unit, London, EnglandClin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Darbyshire, J.
Selby, P.
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Clin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England
Natl Canc Res Network Coordinating Ctr, Leeds, W Yorkshire, EnglandClin Res Network Coordinating Ctr, Natl Inst Hlth Res, Leeds, W Yorkshire, England