-
1
-
-
0003177157
-
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
-
European Parliament and the Council of the European Union
-
European Parliament and the Council of the European Union (2001) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Off J Eur Communities L121:34-44
-
(2001)
Off J Eur Communities
, vol.L121
, pp. 34-44
-
-
-
2
-
-
33947432434
-
Regulation (EC) No 1901/2006, 12 December 2006, on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
-
European Parliament and the Council of the European Union
-
European Parliament and the Council of the European Union (2006) Regulation (EC) No 1901/2006, 12 December 2006, on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Off J Eur Union L378:1-19
-
(2006)
Off J Eur Union
, vol.L378
, pp. 1-19
-
-
-
3
-
-
58149355710
-
Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use
-
European Parliament and the Council of the European Union
-
European Parliament and the Council of the European Union (2006) Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use. Off J Eur Union L378:20-21
-
(2006)
Off J Eur Union
, vol.378
, pp. 20-21
-
-
-
5
-
-
39149118261
-
-
Committee for Medicinal Products for Human Use - CHMP Doc. Ref. CHMP/EWP/83561/2005. Accessed 24 December 2010
-
Committee for Medicinal Products for Human Use - CHMP (2006) Guideline on clinical trials in small populations. Doc. Ref. CHMP/EWP/83561/2005. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/ 09/WC500003615.pdf. Accessed 24 December 2010
-
(2006)
Guideline on Clinical Trials in Small Populations
-
-
-
6
-
-
78649677187
-
-
Committee for Medicinal Products for Human Use - CHMP Doc. Ref. EMEA/CHMP/EWP/9147/2008. Accessed 24 December 2010
-
Committee for Medicinal Products for Human Use - CHMP (2009) Guideline on the clinical development of medicinal products for the treatment of cystic fibrosis. Doc. Ref. EMEA/CHMP/EWP/9147/2008. http://www.ema.europa.eu/docs/en- GB/document-library/Scientific-guideline/2009/12/WC500017055.pdf. Accessed 24 December 2010
-
(2009)
Guideline on the Clinical Development of Medicinal Products for the Treatment of Cystic Fibrosis
-
-
-
10
-
-
79955602816
-
-
Committee for Proprietary Medicinal Products - CPMP EMEA/CPMP/EWP/569/02. Accessed 24 December 2010
-
Committee for Proprietary Medicinal Products - CPMP (2003) Note for guidance on evaluation of anticancer medicinal products in man. Addendum on paediatric oncology. EMEA/CPMP/EWP/569/02. http://www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/2009/10/WC500003969.pdf. Accessed 24 December 2010
-
(2003)
Note for Guidance on Evaluation of Anticancer Medicinal Products in Man. Addendum on Paediatric Oncology
-
-
-
11
-
-
33750536288
-
-
Committee for Medicinal Products for Human Use - CHMP Doc. Ref. EMEA/CPMP/EWP/633/02. Accessed 24 December 2010
-
Committee for Medicinal Products for Human Use - CHMP (2008) Guideline on the clinical development of medicinal products for the treatment of HIV infection. Doc. Ref. EMEA/CPMP/EWP/633/02. http://www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/2009/09/WC500003460.pdf. Accessed 24 December 2010
-
(2008)
Guideline on the Clinical Development of Medicinal Products for the Treatment of HIV Infection
-
-
-
12
-
-
21344441981
-
Ethics and evidence in clinical trials
-
Goodman SN (2005) Ethics and evidence in clinical trials. Clin Trials 2(3):195-196
-
(2005)
Clin Trials
, vol.2
, Issue.3
, pp. 195-196
-
-
Goodman, S.N.1
-
13
-
-
0033118672
-
Ethics and practice: Alternative designs for phase III randomized clinical trials
-
DOI 10.1016/S0197-2456(98)00056-7, PII S0197245698000567
-
Palmer CR, Rosenberger WF (1999) Ethics and practice: alternative designs for phase III randomized clinical trials. Control Clin Trials 20(2):172-186 (Pubitemid 29164458)
-
(1999)
Controlled Clinical Trials
, vol.20
, Issue.2
, pp. 172-186
-
-
Palmer, C.R.1
Rosenberger, W.F.2
-
14
-
-
77149174821
-
Study and protocol design for paediatric patients of different ages
-
Rose K, van den Anker JN (eds) Karger, Basel
-
Della Pasqua O, Zimmerhackl L, Rose K (2007) Study and protocol design for paediatric patients of different ages. In: Rose K, van den Anker JN (eds) Guide to paediatric clinical research. Karger, Basel, pp 87-107
-
(2007)
Guide to Paediatric Clinical Research
, pp. 87-107
-
-
Della Pasqua, O.1
Zimmerhackl, L.2
Rose, K.3
-
15
-
-
65249122540
-
Stopping trials for efficacy: An almost unbiased view
-
Goodman SN (2009) Stopping trials for efficacy: an almost unbiased view. Clin Trials 6(2):133-135
-
(2009)
Clin Trials
, vol.6
, Issue.2
, pp. 133-135
-
-
Goodman, S.N.1
-
16
-
-
70649097002
-
Sequential design with boundaries approach in pediatric intervention research reduces sample size
-
Van der Lee JH, Wesseling J, Tanck MW, Offringa M (2010) Sequential design with boundaries approach in pediatric intervention research reduces sample size. J Clin Epidemiol 63(1):19-27
-
(2010)
J Clin Epidemiol
, vol.63
, Issue.1
, pp. 19-27
-
-
Van Der Lee, J.H.1
Wesseling, J.2
Tanck, M.W.3
Offringa, M.4
-
17
-
-
44949171503
-
Adaptive design methods in clinical trials - A review
-
Chow SC, Chang M (2008) Adaptive design methods in clinical trials - a review. Orphanet J Rare Dis 3:11
-
(2008)
Orphanet J Rare Dis
, vol.3
, pp. 11
-
-
Chow, S.C.1
Chang, M.2
-
18
-
-
70449723061
-
Bayesian design using adult data to augment pediatric trials
-
Schoenfeld DA, Zheng H, Finkelstein DM (2009) Bayesian design using adult data to augment pediatric trials. Clin Trials 6 (4):297-304
-
(2009)
Clin Trials
, vol.6
, Issue.4
, pp. 297-304
-
-
Schoenfeld, D.A.1
Zheng, H.2
Finkelstein, D.M.3
-
19
-
-
24944463173
-
A Bayesian approach to randomized controlled trials in children utilizing information from adults: The case of Guillain-Barré syndrome
-
DOI 10.1191/1740774505cn102oa
-
Goodman SN, Sladky JT (2005) A Bayesian approach to randomized controlled trials in children utilizing information from adults: the case of Guillain-Barré syndrome. Clin Trials 2(4):305-310 (Pubitemid 41306272)
-
(2005)
Clinical Trials
, vol.2
, Issue.4
, pp. 305-310
-
-
Goodman, S.N.1
Sladky, J.T.2
-
20
-
-
0035975973
-
A three-stage clinical trial design for rare disorders
-
DOI 10.1002/sim.980
-
Honkanen VE, Siegel AF et al (2001) A three-stage clinical trial design for rare disorders. Stat Med 20(20):3009-3021 (Pubitemid 32982525)
-
(2001)
Statistics in Medicine
, vol.20
, Issue.20
, pp. 3009-3021
-
-
Honkanen, V.E.A.1
Siegel, A.F.2
Szalai, J.P.3
Berger, V.4
Feldman, B.M.5
Siegel, J.N.6
-
21
-
-
37249081697
-
Antiepileptic drug development in children: Considerations for a revisited strategy
-
Chiron C, Dulac O, Pons G (2008) Antiepileptic drug development in children: considerations for a revisited strategy. Drugs 68 (1):17-25
-
(2008)
Drugs
, vol.68
, Issue.1
, pp. 17-25
-
-
Chiron, C.1
Dulac, O.2
Pons, G.3
-
22
-
-
0030297114
-
Vigabatrin withdrawal randomized study in children
-
DOI 10.1016/S0920-1211(96)00028-9, PII S0920121196000289
-
Chiron C, Dulac O, Gram L (1996) Vigabatrin withdrawal randomized study in children. Epilepsy Res 25(3):209-215 (Pubitemid 26394542)
-
(1996)
Epilepsy Research
, vol.25
, Issue.3
, pp. 209-215
-
-
Chiron, C.1
Dulac, O.2
Gram, L.3
-
23
-
-
33645509617
-
Stiripentol in childhood partial epilepsy: Randomized placebo-controlled trial with enrichment and withdrawal design
-
Chiron C, Tonnelier S, Rey E, Brunet ML, Tran A, d'Athis P, Vincent J, Dulac O, Pons G (2006) Stiripentol in childhood partial epilepsy: randomized placebo-controlled trial with enrichment and withdrawal design. J Child Neurol 21(6):496-502
-
(2006)
J Child Neurol
, vol.21
, Issue.6
, pp. 496-502
-
-
Chiron, C.1
Tonnelier, S.2
Rey, E.3
Brunet, M.L.4
Tran, A.5
D'Athis, P.6
Vincent, J.7
Dulac, O.8
Pons, G.9
-
24
-
-
48349093002
-
Abatacept in children with juvenile idiopathic arthritis: A randomised, double-blind, placebo-controlled withdrawal trial
-
Paediatric Rheumatology International Trials Organization, Pediatric Rheumatology Collaborative Study Group
-
Ruperto N, Lovell DJ, Quartier P, Paz E, Rubio-Pérez N, Silva CA, Abud-Mendoza C, Burgos-Vargas R, Gerloni V, Melo-Gomes JA, Saad-Magalhães C, Sztajnbok F, Goldenstein-Schainberg C, Scheinberg M, Penades IC, Fischbach M, Orozco J, Hashkes PJ, Hom C, Jung L, Lepore L, Oliveira S, Wallace CA, Sigal LH, Block AJ, Covucci A, Martini A, Giannini EH, Paediatric Rheumatology International Trials Organization, Pediatric Rheumatology Collaborative Study Group (2008) Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial. Lancet 372(9636):383-391
-
(2008)
Lancet
, vol.372
, Issue.9636
, pp. 383-391
-
-
Ruperto, N.1
Lovell, D.J.2
Quartier, P.3
Paz, E.4
Rubio-Pérez, N.5
Silva, C.A.6
Abud-Mendoza, C.7
Burgos-Vargas, R.8
Gerloni, V.9
Melo-Gomes, J.A.10
Saad-Magalhães, C.11
Sztajnbok, F.12
Goldenstein-Schainberg, C.13
Scheinberg, M.14
Penades, I.C.15
Fischbach, M.16
Orozco, J.17
Hashkes, P.J.18
Hom, C.19
Jung, L.20
Lepore, L.21
Oliveira, S.22
Wallace, C.A.23
Sigal, L.H.24
Block, A.J.25
Covucci, A.26
Martini, A.27
Giannini, E.H.28
more..
-
25
-
-
49949115223
-
Adalimumab with or without methotrexate in juvenile rheumatoid arthritis
-
Pediatric Rheumatology Collaborative Study Group, Pediatric Rheumatology International Trials Organisation
-
Lovell DJ, Ruperto N, Goodman S, Reiff A, Jung L, Jarosova K, Nemcova D, Mouy R, Sandborg C, Bohnsack J, Elewaut D, Foeldvari I, Gerloni V, Rovensky J, Minden K, Vehe RK, Weiner LW, Horneff G, Huppertz HI, Olson NY, Medich JR, Carcereri-De-Prati R, McIlraith MJ, Giannini EH, Martini A, Pediatric Rheumatology Collaborative Study Group, Pediatric Rheumatology International Trials Organisation (2008) Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med 359(8):810-820
-
(2008)
N Engl J Med
, vol.359
, Issue.8
, pp. 810-820
-
-
Lovell, D.J.1
Ruperto, N.2
Goodman, S.3
Reiff, A.4
Jung, L.5
Jarosova, K.6
Nemcova, D.7
Mouy, R.8
Sandborg, C.9
Bohnsack, J.10
Elewaut, D.11
Foeldvari, I.12
Gerloni, V.13
Rovensky, J.14
Minden, K.15
Vehe, R.K.16
Weiner, L.W.17
Horneff, G.18
Huppertz, H.I.19
Olson, N.Y.20
Medich, J.R.21
Carcereri-De-Prati, R.22
McIlraith, M.J.23
Giannini, E.H.24
Martini, A.25
more..
-
26
-
-
0035014432
-
The randomized placebo-phase design for clinical trials
-
DOI 10.1016/S0895-4356(00)00357-7, PII S0895435600003577
-
Feldman B, Wang E, Willan A, Szalai JP (2001) The randomized placebo-phase design for clinical trials. J Clin Epidemiol 54 (6):550-557 (Pubitemid 32453347)
-
(2001)
Journal of Clinical Epidemiology
, vol.54
, Issue.6
, pp. 550-557
-
-
Feldman, B.1
Wang, E.2
Willan, A.3
Szalai, J.P.4
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