The MGTX experience: Challenges in planning and executing an international, multicenter clinical trial

被引：23

作者：

Aban, Inmaculada B. ^{[1
]}

Wolfe, Gil I. ^{[2
]}

Cutter, Gary R. ^{[1
]}

Kaminski, Henry J. ^{[3
]}

Jaretzki, Alfred, III ^{[4
]}

Minisman, Greg ^{[1
]}

Conwit, Robin ^{[5
]}

Newsom-Davis, John ^{[6
]}

机构：

[1] Univ Alabama, Dept Biostat, Birmingham, AL 35294 USA

[2] Univ Texas SW Med Ctr Dallas, Dept Neurol, Dallas, TX 75390 USA

[3] St Louis Univ, Med Ctr, Dept Neurol & Psychiat, St Louis, MO 63104 USA

[4] Columbia Univ, Med Ctr, Dept Surg, New York, NY 10032 USA

[5] NINDS, Div Extramural Res, NIH, Ctr Neurosci, Bethesda, MD 20892 USA

[6] Univ Oxford, John Radcliffe Hosp, Dept Clin Neurol, Oxford OX3 9DU, England

来源：

JOURNAL OF NEUROIMMUNOLOGY | 2008年 / 201卷

关键词：

Myasthenia gravis; Thymectomy; Regulatory approval;

D O I：

10.1016/j.jneuroim.2008.05.031

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 [免疫学];

摘要：

We present Our experience planning and launching a multinational, NIH/NINDS funded Study of thymectomy in myasthenia gravis. We highlight the additional steps required for international sites and analyze and contrast the time investment required to bring U.S. and non-U.S. sites into full regulatory compliance. Results show the mean time for non-U.S. centers to achieve regulatory approval was significantly longer(mean 13.4 +/- 0.96 months) than for U.S. sites (9.67 +/- 0.74 months; p= 0.0 175, t-test). The delay for non-U.S. sites was mainly attributable to Federalwide Assurance certification and State Department clearance. (C) 2008 Elsevier B.V. All rights reserved.

引用

页码：80 / 84

页数：5

共 12 条

[1]

Regulatory innovation in the governance of human subjects research: A cautionary tale and some modest proposals [J].

Burris, Scott .

REGULATION & GOVERNANCE, 2008, 2 (01) :65-84

[2]

MYASTHENIA-GRAVIS - POPULATION DIFFERENCES IN DISEASE EXPRESSION AND ACETYLCHOLINE-RECEPTOR ANTIBODY-TITERS BETWEEN CHINESE AND CAUCASIANS [J].

CHIU, HC ;

VINCENT, A ;

NEWSOMDAVIS, J ;

HSIEH, KH ;

HUNG, TP .

NEUROLOGY, 1987, 37 (12) :1854-1857

[3]

The role of the data coordinating center in the IRB review and approval process: the DIG trial experience [J].

Collins, JF ;

Garg, R ;

Teo, KK ;

Williford, WO ;

Howell, CL .

CONTROLLED CLINICAL TRIALS, 2003, 24 (06) :306S-315S

[4]

CLINICAL, PATHOLOGICAL, HLA-ANTIGEN AND IMMUNOLOGICAL EVIDENCE FOR DISEASE HETEROGENEITY IN MYASTHENIA-GRAVIS [J].

COMPSTON, DAS ;

VINCENT, A ;

NEWSOMDAVIS, J ;

BATCHELOR, JR .

BRAIN, 1980, 103 (SEP) :579-601

[5]

Specific barriers to the conduct of randomized trials [J].

Duley, Lelia ;

Antman, Karen ;

Arena, Joseph ;

Avezum, Alvaro ;

Blumenthal, Mel ;

Bosch, Jackie ;

Chrolavicius, Sue ;

Li, Timoa ;

Ounpuu, Stephanie ;

Perez, Analia Cristina ;

Sleight, Peter ;

Svard, Robbyno ;

Temple, Robert ;

Tsouderous, Yannis ;

Yunis, Carla ;

Yusuf, Salim .

CLINICAL TRIALS, 2008, 5 (01) :40-48

[6]

Myasthenia gravis in South Africans: Racial differences in clinical manifestations [J].

Heckmann, J. M. ;

Owen, E. P. ;

Little, F. .

NEUROMUSCULAR DISORDERS, 2007, 17 (11-12) :929-934

[7]

Regulatory approvals in a large multinational clinical trial: the ESPRIT experience [J].

McNay, LA ;

Tavel, JA ;

Oseekey, K ;

McDermott, CM ;

Mollerup, D ;

Bebchuk, JD .

CONTROLLED CLINICAL TRIALS, 2002, 23 (01) :59-66

[8]

NEWSOMDAVIS I, 2008, AM NY ACAD SCI, V1132, P344

[9]

The epidemiology of myasthenia gravis [J].

Phillips, LH .

MYASTHENIA GRAVIS AND RELATED DISORDERS: BIOMCHEMICAL BASIS FOR DISEASE OF THE NEUROMUSCULAR JUNCTION, 2003, 998 :407-412

[10]

THE EPIDEMIOLOGY OF MYASTHENIA-GRAVIS IN CENTRAL AND WESTERN VIRGINIA [J].

PHILLIPS, LH ;

TORNER, JC ;

ANDERSON, MS ;

COX, GM .

NEUROLOGY, 1992, 42 (10) :1888-1893

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