-
1
-
-
48749122516
-
Trends in disease focus of drug development
-
doi:10.1038/nrd2618 PubMed
-
Karlberg JPE. Trends in disease focus of drug development. Nat Rev Drug Discov. 2008;7(8):639-640. doi:10.1038/nrd2618 PubMed
-
(2008)
Nat Rev Drug Discov
, vol.7
, Issue.8
, pp. 639-640
-
-
Karlberg, J.P.E.1
-
2
-
-
0027510643
-
The de facto US mental and addictive disorders service system: Epidemiologic Catchment Area prospective 1-year prevalence rates of disorders and services
-
Regier DA, Narrow WE, Rae DS, et al. The de facto US mental and addictive disorders service system: Epidemiologic Catchment Area prospective 1-year prevalence rates of disorders and services. Arch Gen Psychiatry. 1993;50(2):85-94. doi:10.101/archpsyc.193.01820140701 PubMed (Pubitemid 23059313)
-
(1993)
Archives of General Psychiatry
, vol.50
, Issue.2
, pp. 85-94
-
-
Regier, D.A.1
Narrow, W.E.2
Rae, D.S.3
Manderscheid, R.W.4
Locke, B.Z.5
Goodwin, F.K.6
-
3
-
-
0031578840
-
The 100-year epidemiology of schizophrenia
-
DOI 10.1016/S0920-9964(97)85354-6, PII S0920996497001084
-
Jablensky A. The 100-year epidemiology of schizophrenia. Schizophr Res. 1997;28(2-3):111-125. doi:10.1016/S0920-964(97)85354-6 PubMed (Pubitemid 28055660)
-
(1997)
Schizophrenia Research
, vol.28
, Issue.2-3
, pp. 111-125
-
-
Jablensky, A.1
-
4
-
-
2942648152
-
Schizophrenia
-
DOI 10.1016/S0140-6736(04)16458-1, PII S0140673604164581
-
Mueser KT, McGurk SR. Schizophrenia. Lancet. 2004;363(9426):2063-2072. doi:10.1016/S0140-6736(04)16458-1 PubMed (Pubitemid 38781110)
-
(2004)
Lancet
, vol.363
, Issue.9426
, pp. 2063-2072
-
-
Mueser, K.T.1
McGurk, S.R.2
-
5
-
-
0035180445
-
The scientific and ethical basis for placebo-controlled trials in depression and schizophrenia: An FDA perspective
-
DOI 10.1016/S0924-9338(01)00600-9
-
Laughren TP. The scientific and ethical basis for placebo-controlled trials in depression and schizophrenia: an FDA perspective. Eur Psychiatry. 2001;16(7):418-423. doi:10.1016/S0924-938(01)060-9 PubMed (Pubitemid 33101277)
-
(2001)
European Psychiatry
, vol.16
, Issue.7
, pp. 418-423
-
-
Laughren, T.P.1
-
6
-
-
62849099049
-
How effective are second-generation antipsychotic drugs? A meta-analysis of placebo-controlled trials
-
doi:10.1038/sj.mp.402136 PubMed
-
Leucht S, Arbter D, Engel RR, et al. How effective are second-generation antipsychotic drugs? a meta-analysis of placebo-controlled trials. Mol Psychiatry. 2009;14(4):429-447. doi:10.1038/sj.mp.402136 PubMed
-
(2009)
Mol Psychiatry
, vol.14
, Issue.4
, pp. 429-447
-
-
Leucht, S.1
Arbter, D.2
Engel, R.R.3
-
7
-
-
77953179885
-
What is causing the reduced drug-placebo difference in recent schizophrenia clinical trials and what can be done about it?
-
doi:10.1093/schbul/sbn10 PubMed
-
Kemp AS, Schooler NR, Kalali AH, et al. What is causing the reduced drug-placebo difference in recent schizophrenia clinical trials and what can be done about it? Schizophr Bull. 2010;36(3):504-509. doi:10.1093/schbul/sbn10 PubMed
-
(2010)
Schizophr Bull
, vol.36
, Issue.3
, pp. 504-509
-
-
Kemp, A.S.1
Schooler, N.R.2
Kalali, A.H.3
-
8
-
-
77957366833
-
Trial design issues and treatment effect modeling in multi-regional schizophrenia trials
-
doi:10.102/pst.439 PubMed
-
Chen YF, Wang SJ, Khin NA, et al. Trial design issues and treatment effect modeling in multi-regional schizophrenia trials. Pharm Stat. 2010;9(3):217-229. doi:10.102/pst.439 PubMed
-
(2010)
Pharm Stat
, vol.9
, Issue.3
, pp. 217-229
-
-
Chen, Y.F.1
Wang, S.J.2
Khin, N.A.3
-
9
-
-
37749010578
-
Trends in the globalization of clinical trials
-
doi:10.1038/nrd241
-
Thiers FA, Sinskey AJ, Berndt ER. Trends in the globalization of clinical trials. Nat Rev Drug Discov. 2008;7(1):13-14. doi:10.1038/nrd241
-
(2008)
Nat Rev Drug Discov
, vol.7
, Issue.1
, pp. 13-14
-
-
Thiers, F.A.1
Sinskey, A.J.2
Berndt, E.R.3
-
10
-
-
84942819604
-
-
US Department of Health and Human Services. Revised April 1, 2011. Updated July 29, Accessed August 2, 2011
-
US Department of Health and Human Services. Code of Federal Regulations, Title 21-Food and Drugs, Part 314, Applications for FDA Approval to Market a New Drug. 21 CFR Part 314.106: Foreign Data. http://ecfr.gpoaccess.gov/cgi/t/text/ text-idx?c=ecfr;sid=c4683e3b7214a3bef6f567bc293ff57c;rgn=div5;view=text;node= 21%3A5.0.1.1.4;idno=21;cc=ecfr#21:5.0.1.1.4.4.1.7. Revised April 1, 2011. Updated July 29, 2011. Accessed August 2, 2011.
-
(2011)
Code of Federal Regulations, Title 21-Food and Drugs, Part 314, Applications for FDA Approval to Market A New Drug. 21 CFR Part 314.106: Foreign Data
-
-
-
11
-
-
84942819026
-
-
US Department of Health and Human Services. Revised April 1, 2011. Updated September 7, Accessed Sept 9, 2011
-
US Department of Health and Human Services. Code of Federal Regulations, Title 21-Food and Drugs, Part 312, Investigational New Drug Applications. 21 CFR 312.120: Foreign Clinical Studies Not Conducted Under an IND. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid= d199e7693c50a9bb0de86c4b652807c7&rgn=div8&view=text&node=21:5.0.1.1. 3.6.1.2&idno=21. Revised April 1, 2011. Updated September 7, 2011. Accessed Sept 9, 2011.
-
(2011)
Code of Federal Regulations, Title 21-Food and Drugs, Part 312, Investigational New Drug Applications. 21 CFR 312.120: Foreign Clinical Studies Not Conducted under An IND
-
-
-
12
-
-
4444237870
-
-
Topic ICH. E5 (R1). CPMP/ICH/289/95. Published September Accessed August 3, 2011
-
Topic ICH. E5 (R1). Ethnic Factors in the Acceptability of Foreign Clinical Data. CPMP/ICH/289/95. http://www.ema.europa.eu/docs/en-GB/document- library/Scientific-guideline/2009/09/WC500002842.pdf. Published September 1998. Accessed August 3, 2011.
-
(1998)
Ethnic Factors in the Acceptability of Foreign Clinical Data
-
-
-
13
-
-
84942832946
-
-
Topic ICH. E6 (R1). Accessed October 27, 2011
-
Topic ICH. E6 (R1). Good Clinical Practice. Finalized Guideline: May 1996. http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/ good-clinical-practice.html. Accessed October 27, 2011.
-
Good Clinical Practice. Finalized Guideline: May 1996
-
-
-
14
-
-
84942818131
-
Use of non-US data in NDAs. Special session: Regulatory Considerations of Using Non-US Data in NDAs: Focus on Efficacy, Safety and Clinical Pharmacology
-
Presented at the Accessed March 10, 2011
-
Temple R. Use of non-US data in NDAs. Special session: Regulatory Considerations of Using Non-US Data in NDAs: Focus on Efficacy, Safety and Clinical Pharmacology. Presented at the Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics; March 20, 2009; Washington, DC. http://www.ascpt.org/Portals/8/docs/Meetings/2009%20Annual%20Meeting/Friday/ Regulatory%20Considerations.pdf. Accessed March 10, 2011.
-
Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics; March 20, 2009; Washington, DC
-
-
Temple, R.1
-
15
-
-
79955518260
-
-
Committee for Medicinal Products for Human Use (CHMP). EMEA/CHMP/EWP/692702/2008: Published February 19, Updated October 22, 2009. Accessed March 10, 2011
-
Committee for Medicinal Products for Human Use (CHMP). European Medicines Agency (EMEA): reflection paper on the extrapolation of results from clinical studies conducted outside Europe to the EU-population. EMEA/CHMP/EWP/692702/ 2008: 1-7. http://www.ema. europa.eu/docs/en-GB/document-library/Scientific- guideline/2009/11/WC500013468.pdf. Published February 19, 2009. Updated October 22, 2009. Accessed March 10, 2011.
-
(2009)
European Medicines Agency (EMEA): Reflection Paper on the Extrapolation of Results from Clinical Studies Conducted Outside Europe to the EU-population
, pp. 1-7
-
-
-
16
-
-
0023606101
-
The positive and negative syndrome scale (PANSS) for schizophrenia
-
Kay SR, Fiszbein A, Opler LA. The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-276. PubMed (Pubitemid 18039085)
-
(1987)
Schizophrenia Bulletin
, vol.13
, Issue.2
, pp. 261-276
-
-
Kay, S.R.1
Fiszbein, A.2
Opler, L.A.3
-
17
-
-
0023858453
-
Reliability and validity of the Positive and Negative Syndrome Scale for schizophrenics
-
doi:10.1016/0165-1781(8)9038-8 PubMed
-
Kay SR, Opler LA, Lindenmayer JP. Reliability and validity of the Positive and Negative Syndrome Scale for schizophrenics. Psychiatry Res. 1988;23(1):99-110. doi:10.1016/0165-1781(8)9038-8 PubMed
-
(1988)
Psychiatry Res
, vol.23
, Issue.1
, pp. 99-110
-
-
Kay, S.R.1
Opler, L.A.2
Lindenmayer, J.P.3
-
18
-
-
0000503515
-
The Brief Psychiatric Rating Scale
-
Overall JE, Gorham DR. The Brief Psychiatric Rating Scale. Psychol Rep. 1962;10:799-812.
-
(1962)
Psychol Rep
, vol.10
, pp. 799-812
-
-
Overall, J.E.1
Gorham, D.R.2
-
20
-
-
79955486643
-
Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications
-
doi:10.408/JCP.10m06191 PubMed
-
Khin NA, Chen YF, Yang Y, et al. Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications. J Clin Psychiatry. 2011;72(4):464-472. doi:10.408/JCP.10m06191 PubMed
-
(2011)
J Clin Psychiatry
, vol.72
, Issue.4
, pp. 464-472
-
-
Khin, N.A.1
Chen, Y.F.2
Yang, Y.3
-
21
-
-
70349967831
-
Worldwide-Schizophrenia Outpatient Health Outcomes (W-SOHO): Baseline characteristics of pan-regional observational data from more than 17,000 patients
-
doi:10.1/j.1742-1241.209.02191.x PubMed
-
Karagianis J, Novick D, Pecenak J, et al. Worldwide-Schizophrenia Outpatient Health Outcomes (W-SOHO): baseline characteristics of pan-regional observational data from more than 17,000 patients. Int J Clin Pract. 2009;63(11):1578-1588. doi:10.1/j.1742-1241.209.02191.x PubMed
-
(2009)
Int J Clin Pract
, vol.63
, Issue.11
, pp. 1578-1588
-
-
Karagianis, J.1
Novick, D.2
Pecenak, J.3
-
22
-
-
0027933111
-
Does a placebo run-in or a placebo treatment cell affect the efficacy of antidepressant medications?
-
Trivedi MH, Rush H. Does a placebo run-in or a placebo treatment cell affect the efficacy of antidepressant medications? Neuropsychopharmacology. 1994;11(1):33-43. PubMed (Pubitemid 24277736)
-
(1994)
Neuropsychopharmacology
, vol.11
, Issue.1
, pp. 33-43
-
-
Trivedi, M.H.1
Rush, J.2
-
23
-
-
0035195571
-
The double-blind variable placebo lead-in period: Results from two antidepressant clinical trials
-
DOI 10.1097/00004714-200112000-00004
-
Faries DE, Heiligenstein JH, Tollefson GD, et al. The double-blind variable placebo lead-in period: results from two antidepressant clinical trials. J Clin Psychopharmacol. 2001;21(6):561-568. doi:10.1097/04714-20120-04 PubMed (Pubitemid 33116654)
-
(2001)
Journal of Clinical Psychopharmacology
, vol.21
, Issue.6
, pp. 561-568
-
-
Faries, D.E.1
Heiligenstein, J.H.2
Tollefson, G.D.3
Potter, W.Z.4
-
24
-
-
1542290332
-
Does elimination of placebo responders in a placebo run-in increase the treatment effect in randomized clinical trials? A meta-analytic evaluation
-
DOI 10.1002/da.10134
-
Lee S, Walker JR, Jakul L, et al. Does elimination of placebo responders in a placebo run-in increase the treatment effect in randomized clinical trials? a meta-analytic evaluation. Depress Anxiety. 2004;19(1):10-19. doi:10.102/da.10134 PubMed (Pubitemid 38294604)
-
(2004)
Depression and Anxiety
, vol.19
, Issue.1
, pp. 10-19
-
-
Lee, S.1
Walker, J.R.2
Jakul, L.3
Sexton, K.4
-
25
-
-
79957442287
-
Evaluation of performance of some enrichment designs dealing with high placebo response in psychiatric clinical trials
-
doi:10.1016/j.ct.201.04.06 PubMed
-
Chen YF, Yang Y, Hung HMJ, et al. Evaluation of performance of some enrichment designs dealing with high placebo response in psychiatric clinical trials. Contemp Clin Trials. 2011;32(4):592-604. doi:10.1016/j.ct.201.04.06 PubMed
-
(2011)
Contemp Clin Trials
, vol.32
, Issue.4
, pp. 592-604
-
-
Chen, Y.F.1
Yang, Y.2
Hung, H.M.J.3
-
26
-
-
0037266035
-
The problem of the placebo response in clinical trials for psychiatric disorders: Culprits, possible remedies, and a novel study design approach
-
DOI 10.1159/000069738
-
Fava M, Evins AE, Dorer DJ, et al. The problem of the placebo response in clinical trials for psychiatric disorders: culprits, possible remedies, and a novel study design approach. Psychother Psychosom. 2003;72(3):115-127. doi:10.159/069738 PubMed (Pubitemid 36469860)
-
(2003)
Psychotherapy and Psychosomatics
, vol.72
, Issue.3
, pp. 115-127
-
-
Fava, M.1
Evins, A.E.2
Dorer, D.J.3
Schoenfeld, D.A.4
-
27
-
-
35348862526
-
An examination of the efficiency of the sequential parallel design in psychiatric clinical trials
-
DOI 10.1177/1740774507081217
-
Tamura RN, Huang X. An examination of the efficiency of the sequential parallel design in psychiatric clinical trials. Clin Trials. 2007;4(4):309-317. doi:10.17/174074507081217 PubMed (Pubitemid 47572263)
-
(2007)
Clinical Trials
, vol.4
, Issue.4
, pp. 309-317
-
-
Tamura, R.N.1
Huang, X.2
-
28
-
-
0034116120
-
The impact of restrictive entry criterion during the placebo lead-in period
-
Landin R, DeBrota DJ, DeVries TA, et al. The impact of restrictive entry criterion during the placebo lead-in period. Biometrics. 2000;56(1):271-278. doi:10.1/j.06-341X.20.0271.x PubMed (Pubitemid 30165119)
-
(2000)
Biometrics
, vol.56
, Issue.1
, pp. 271-278
-
-
Landin, R.1
DeBrota, D.J.2
DeVries, T.A.3
Potter, W.Z.4
Demitrack, M.A.5
-
29
-
-
40049084167
-
Methodological issues in current antipsychotic drug trials
-
DOI 10.1093/schbul/sbm159
-
Leucht S, Heres S, Hamann J, et al. Methodological issues in current antipsychotic drug trials. Schizophr Bull. 2008;34(2):275-285. doi:10.1093/schbul/sbm159 PubMed (Pubitemid 351323339)
-
(2008)
Schizophrenia Bulletin
, vol.34
, Issue.2
, pp. 275-285
-
-
Leucht, S.1
Heres, S.2
Hamann, J.3
Kane, J.M.4
-
30
-
-
68149132485
-
Dropout rates in randomized clinical trials of antipsychotics: A meta-analysis comparing first- and second-generation drugs and an examination of the role of trial design features
-
doi:10.1093/schbul/sbn05 PubMed
-
Rabinowitz J, Levine SZ, Barkai O, et al. Dropout rates in randomized clinical trials of antipsychotics: a meta-analysis comparing first- and second-generation drugs and an examination of the role of trial design features. Schizophr Bull. 2009;35(4):775-788. doi:10.1093/schbul/sbn05 PubMed
-
(2009)
Schizophr Bull
, vol.35
, Issue.4
, pp. 775-788
-
-
Rabinowitz, J.1
Levine, S.Z.2
Barkai, O.3
-
31
-
-
33846245890
-
Why do clinical trials fail?: The problem of measurement error in clinical trials: Time to test new paradigms?
-
DOI 10.1097/JCP.0b013e31802eb4b7, PII 0000471420070200000001
-
Kobak KA, Kane JM, Thase ME, et al. Why do clinical trials fail? the problem of measurement error in clinical trials: time to test new paradigms? J Clin Psychopharmacol. 2007;27(1):1-5. doi:10.1097/JCP.0b013e31802eb4b7 PubMed (Pubitemid 46105756)
-
(2007)
Journal of Clinical Psychopharmacology
, vol.27
, Issue.1
, pp. 1-5
-
-
Kobak, K.A.1
Kane, J.M.2
Thase, M.E.3
Nierenberg, A.A.4
-
32
-
-
59049100877
-
Use of remote centralized raters via live 2-way video in a multicenter clinical trial for schizophrenia
-
doi:10.1097/JCP.0b013e31818c9ba3 PubMed
-
Shen J, Kobak KA, Zhao Y, et al. Use of remote centralized raters via live 2-way video in a multicenter clinical trial for schizophrenia. J Clin Psychopharmacol. 2008;28(6):691-693. doi:10.1097/JCP.0b013e31818c9ba3 PubMed
-
(2008)
J Clin Psychopharmacol
, vol.28
, Issue.6
, pp. 691-693
-
-
Shen, J.1
Kobak, K.A.2
Zhao, Y.3
-
33
-
-
43049094108
-
Is bigger better for depression trials?
-
DOI 10.1016/j.jpsychires.2007.07.003, PII S0022395607001069
-
Liu KS, Snavely DB, Ball WA, et al. Is bigger better for depression trials? J Psychiatr Res. 2008;42(8):622-630. doi:10.1016/j.jpsychires.207.07.03 (Pubitemid 351626061)
-
(2008)
Journal of Psychiatric Research
, vol.42
, Issue.8
, pp. 622-630
-
-
Liu, K.S.1
Snavely, D.B.2
Ball, W.A.3
Lines, C.R.4
Reines, S.A.5
Potter, W.Z.6
|