-
1
-
-
44949141642
-
Recombinant interferon beta or glatiramer acetate for delaying conversion of the first demyelinating event to multiple sclerosis
-
Clerico M., Faggiano F., Palace J., et al. Recombinant interferon beta or glatiramer acetate for delaying conversion of the first demyelinating event to multiple sclerosis. Cochrane Database Systematic Rev 2008 ; 2: CD005278.
-
(2008)
Cochrane Database Systematic Rev
, vol.2
, pp. 005278
-
-
Clerico, M.1
Faggiano, F.2
Palace, J.3
-
2
-
-
56549105235
-
Disease-modifying agents for multiple sclerosis: Recent advances and future prospects
-
Menge T., Weber MS, Hemmer B., et al. Disease-modifying agents for multiple sclerosis: recent advances and future prospects. Drugs 2008 ; 68: 2445-2468.
-
(2008)
Drugs
, vol.68
, pp. 2445-2468
-
-
Menge, T.1
Weber, M.S.2
Hemmer, B.3
-
3
-
-
54149084585
-
Multiple sclerosis
-
Compston A. and Coles A. Multiple sclerosis. Lancet 2008 ; 372: 1502-1517.
-
(2008)
Lancet
, vol.372
, pp. 1502-1517
-
-
Compston, A.1
Coles, A.2
-
4
-
-
0037374498
-
The price of innovation: New estimates of drug development costs
-
DiMasi JA, Hansen RW and Grabowski HG The price of innovation: New estimates of drug development costs. J Health Econ 2003 ; 22: 151-185.
-
(2003)
J Health Econ
, vol.22
, pp. 151-185
-
-
Dimasi, J.A.1
Hansen, R.W.2
Grabowski, H.G.3
-
5
-
-
0033618626
-
Combining different phases in the development of medical treatments within a single trial
-
Bauer P. and Kieser M. Combining different phases in the development of medical treatments within a single trial. Statist Med 1999 ; 18: 1833-1848.
-
(1999)
Statist Med
, vol.18
, pp. 1833-1848
-
-
Bauer, P.1
Kieser, M.2
-
6
-
-
33748521268
-
Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: General concepts
-
DOI 10.1002/bimj.200510232
-
Bretz F., Schmidli H., Koenig F., et al. Confirmatory seamless phase II/III clinical trials with hypo-theses selection at interim: general concepts. Biometrical J 2006 ; 48: 623-634. (Pubitemid 44367905)
-
(2006)
Biometrical Journal
, vol.48
, Issue.4
, pp. 623-634
-
-
Bretz, F.1
Schmidli, H.2
Konig, F.3
Racine, A.4
Maurer, W.5
-
7
-
-
54549109142
-
A comparison of methods for adaptive treatment selection
-
Friede T. and Stallard N. A comparison of methods for adaptive treatment selection. Biometrical J 2008 ; 50: 767-781.
-
(2008)
Biometrical J
, vol.50
, pp. 767-781
-
-
Friede, T.1
Stallard, N.2
-
9
-
-
0021035886
-
Rating neurologic impairment in multiple sclerosis: An Expanded Disability Status Scale (EDSS)
-
Kurtzke JF Rating neurologic impairment in multiple sclerosis: an Expanded Disability Status Scale (EDSS). Neurology 1983 ; 33: 1444-1452.
-
(1983)
Neurology
, vol.33
, pp. 1444-1452
-
-
Kurtzke, J.F.1
-
10
-
-
0035010231
-
The Multiple Sclerosis Impact Scale (MSIS-29): A new patient-based outcome measure
-
Hobart J., Lamping D., Fitzpatrick R., et al. The Multiple Sclerosis Impact Scale (MSIS-29): a new patient-based outcome measure. Brain 2001 ; 124: 962-973.
-
(2001)
Brain
, vol.124
, pp. 962-973
-
-
Hobart, J.1
Lamping, D.2
Fitzpatrick, R.3
-
11
-
-
0029279166
-
Outcomes assessment in multiple sclerosis clinical trials: A critical analysis
-
Whitaker JN, McFarland HF, Rudge P., et al. Outcomes assessment in multiple sclerosis clinical trials: a critical analysis. Mult Scler 1995 ; 1: 37-47.
-
(1995)
Mult Scler
, vol.1
, pp. 37-47
-
-
Whitaker, J.N.1
McFarland, H.F.2
Rudge, P.3
-
12
-
-
9544238232
-
Clinical outcomes assessment in multiple sclerosis
-
Rudick R., Fischer J., Antel J., et al. Clinical outcomes assessment in multiple sclerosis. Ann Neurol 1996 ; 40: 469-479. (Pubitemid 26304809)
-
(1996)
Annals of Neurology
, vol.40
, Issue.3
, pp. 469-479
-
-
Rudick, R.1
Antel, J.2
Confavreux, C.3
Cutter, G.4
Ellison, G.5
Fischer, J.6
Lublin, F.7
Miller, A.8
Petkau, J.9
Rao, S.10
Reingold, S.11
Syndulko, K.12
Thompson, A.13
Wallenberg, J.14
Weinshenker, B.15
Willoughby, E.16
-
13
-
-
78650971285
-
Designing a seamless phase II/III clinical trial using early outcomes for treatment selection: An application in multiple sclerosis
-
Friede T., Parsons N., Stallard N., et al. Designing a seamless phase II/III clinical trial using early outcomes for treatment selection: an application in multiple sclerosis. Statist Med 2010 ; (submitted).
-
(2010)
Statist Med
-
-
Friede, T.1
Parsons, N.2
Stallard, N.3
-
14
-
-
78249260148
-
Aspects of modernizing drug development using clinical scenario planning and evaluation
-
Benda N., Branson M., Maurer W., et al. Aspects of modernizing drug development using clinical scenario planning and evaluation. Drug Inform J 2010 ; 44: 299-315.
-
(2010)
Drug Inform J
, vol.44
, pp. 299-315
-
-
Benda, N.1
Branson, M.2
Maurer, W.3
-
15
-
-
78249260149
-
Refinement of the clinical scenario evaluation framework for assessment of competing development strategies with an application to multiple sclerosis
-
Friede T., Nicholas R., Stallard N., et al. Refinement of the clinical scenario evaluation framework for assessment of competing development strategies with an application to multiple sclerosis. Drug Inform J 2010 ; (in press).
-
(2010)
Drug Inform J
-
-
Friede, T.1
Nicholas, R.2
Stallard, N.3
-
16
-
-
84929552894
-
Guidelines on clinical investigation of medicinal products for the treatment of multiple sclerosis
-
Emea. Guidelines on clinical investigation of medicinal products for the treatment of multiple sclerosis. European Medicines Agency, 2005. Available at http://www.emea.europa.eu/pdfs/human/ewp/056198en.pdf (accessed 24 November 2009 ).
-
(2005)
European Medicines Agency
-
-
Emea1
-
17
-
-
68349107070
-
Imaging outcomes for neuroprotection and repair in multiple sclerosis trials
-
Barkhof F., Calabresi PA, Miller DH, et al. Imaging outcomes for neuroprotection and repair in multiple sclerosis trials. Nat Rev Neurol 2009 ; 5: 256-266.
-
(2009)
Nat Rev Neurol
, vol.5
, pp. 256-266
-
-
Barkhof, F.1
Calabresi, P.A.2
Miller, D.H.3
-
18
-
-
61849095259
-
Sample sizes for brain atrophy outcomes in trials for secondary progressive multiple sclerosis
-
Altmann DR, Jasperse B., Barkhof F., et al. Sample sizes for brain atrophy outcomes in trials for secondary progressive multiple sclerosis. Neurology 2009 ; 72: 595-601.
-
(2009)
Neurology
, vol.72
, pp. 595-601
-
-
Altmann, D.R.1
Jasperse, B.2
Barkhof, F.3
-
20
-
-
0037883298
-
MRI metrics as surrogate endpoints for EDSS progression in SPMS patients treated with IFN beta-1b
-
Sormani MP, Bruzzi P., Beckmann K., et al. MRI metrics as surrogate endpoints for EDSS progression in SPMS patients treated with IFN beta-1b. Neurology 2003 ; 60: 1462-1466.
-
(2003)
Neurology
, vol.60
, pp. 1462-1466
-
-
Sormani, M.P.1
Bruzzi, P.2
Beckmann, K.3
-
21
-
-
0035849494
-
The SPECTRIMS Study Group. Randomized controlled trial of iterferon-beta-1a in secondary progressive MS: MRI results
-
University Of British Columbia
-
Li DK, Zhao GJ and Paty DW, University of British Columbia MS / MRI Analysis Research Group: The SPECTRIMS Study Group. Randomized controlled trial of iterferon-beta-1a in secondary progressive MS: MRI results. Neurology 2001 ; 56: 1505-1513.
-
(2001)
Neurology
, vol.56
, pp. 1505-1513
-
-
Li, D.K.1
Zhao, G.J.2
Paty, D.W.3
-
22
-
-
8844222623
-
North American Study group on Interferon beta-1b in Secondary Progressive MS. Interferon beta-1b in secondary progressive MS: Results from 3-year controlled study
-
North American Study group on Interferon beta-1b in Secondary Progressive MS. Interferon beta-1b in secondary progressive MS: results from 3-year controlled study. Neurology 2004 ; 63: 1788-1795.
-
(2004)
Neurology
, vol.63
, pp. 1788-1795
-
-
-
23
-
-
20444393946
-
The past is the future: Innovative designs in acute stroke therapy trials
-
Krams M., Lees KR and Berry DA The past is the future: innovative designs in acute stroke therapy trials. Stroke 2005 ; 36: 1341-1347.
-
(2005)
Stroke
, vol.36
, pp. 1341-1347
-
-
Krams, M.1
Lees, K.R.2
Berry, D.A.3
-
24
-
-
33750854113
-
Adaptive seamless phase II/III designs - Background, operational aspects, and examples
-
Maca J., Bhattacharya S., Dragalin V., et al. Adaptive seamless phase II/III designs - Background, operational aspects, and examples. Drug Inform J 2006 ; 40: 463-473.
-
(2006)
Drug Inform J
, vol.40
, pp. 463-473
-
-
MacA, J.1
Bhattacharya, S.2
Dragalin, V.3
-
25
-
-
77951470682
-
A double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of dirucotide in patients with secondary progressive multiple sclerosis
-
Freedman MS, Verco T., Ossanna M., et al. A double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of dirucotide in patients with secondary progressive multiple sclerosis. Mult Scler 2009 ; 15: S272 - S273.
-
(2009)
Mult Scler
, vol.15
-
-
Freedman, M.S.1
Verco, T.2
Ossanna, M.3
|