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Volumn 29, Issue 3, 2007, Pages 283-290

Current clinical research environment. Focus on Psychiatry

Author keywords

Clinical research; Clinical trial registration; Conflict of interest; Placebo; Regulatory approval

Indexed keywords

ANTIDEPRESSANT AGENT; CHLORPROMAZINE; CLOZAPINE; MONOCLONAL ANTIBODY; MOOD STABILIZER; NEUROLEPTIC AGENT; OLANZAPINE; PERPHENAZINE; PLACEBO; QUETIAPINE; RISPERIDONE; ROFECOXIB; SEROTONIN UPTAKE INHIBITOR; TGN 1412; UNCLASSIFIED DRUG; ZIPRASIDONE;

EID: 42449136694     PISSN: 15164446     EISSN: None     Source Type: Journal    
DOI: 10.1590/s1516-44462006005000049     Document Type: Review
Times cited : (5)

References (43)
  • 2
    • 6044267892 scopus 로고    scopus 로고
    • Failing the public health - rofecoxib, Merck and the FDA
    • Topol EJ. Failing the public health - rofecoxib, Merck and the FDA. NEJM. 2004;351(17):1707-9.
    • (2004) NEJM , vol.351 , Issue.17 , pp. 1707-1709
    • Topol, E.J.1
  • 3
    • 33645846038 scopus 로고    scopus 로고
    • Seeking harmonization and quality in clinical trials
    • Dainesi SM. Seeking harmonization and quality in clinical trials. Clinics. 2005;61(1):3-8.
    • (2005) Clinics , vol.61 , Issue.1 , pp. 3-8
    • Dainesi, S.M.1
  • 5
    • 33747188665 scopus 로고    scopus 로고
    • Pharmacovigilance: More than ever, an overall responsibility
    • Dainesi SM. Pharmacovigilance: more than ever, an overall responsibility. Clinics. 2005;60(4):267-70.
    • (2005) Clinics , vol.60 , Issue.4 , pp. 267-270
    • Dainesi, S.M.1
  • 6
    • 0035941525 scopus 로고    scopus 로고
    • Completeness of safety reporting in randomized trials: An evaluation of 7 medical areas
    • Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA. 2001;285(4):437-43.
    • (2001) JAMA , vol.285 , Issue.4 , pp. 437-443
    • Ioannidis, J.P.1    Lau, J.2
  • 7
    • 0035906308 scopus 로고    scopus 로고
    • CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT Statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials
    • Moher D, Schulz KF, Altman D. CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA. 2001;285(15):1987-91.
    • (2001) JAMA , vol.285 , Issue.15 , pp. 1987-1991
    • Moher, D.1    Schulz, K.F.2    Altman, D.3
  • 8
    • 33751543994 scopus 로고    scopus 로고
    • Revised recommendatios for improving the quality of reports of parallel group randomized trials 2001. CONSORT Group
    • cited July 30, Available from
    • Moher D, Schulz KF, Altman DG. Revised recommendatios for improving the quality of reports of parallel group randomized trials 2001. CONSORT Group. The CONSORT Statement. [cited 2006 July 30]. Available from: http://www.consort- statement.org/Statement/revisedstatement.htm
    • (2006) The CONSORT Statement
    • Moher, D.1    Schulz, K.F.2    Altman, D.G.3
  • 9
    • 33846678965 scopus 로고    scopus 로고
    • Available from
    • World Medical Association, Declaration of Helsinki. Ethical principles for medical research involving human subjects, cited July 30
    • [No authors listed]. World Medical Association - Declaration of Helsinki. Ethical principles for medical research involving human subjects. [cited 2006 July 30]. Available from: http://www.wma.net/e/policy/b3.htm
    • (2006)
  • 10
    • 85062130906 scopus 로고    scopus 로고
    • cited July 30, Available from
    • [No authors listed]. Directives for human experimentation. Nuremberg Code. [cited 2006 July 30]. Available from: http://ohsr.od.nih.gov/guidelines/ nuremberg.html
    • (2006) Nuremberg Code, Directives for human experimentation
  • 11
    • 85062132682 scopus 로고    scopus 로고
    • Putting safety first
    • Peachey J. Putting safety first. Scrip Magazine. 2003;17-8.
    • (2003) Scrip Magazine , pp. 17-18
    • Peachey, J.1
  • 12
    • 85062124696 scopus 로고    scopus 로고
    • Hurley D. Leveraging Latin America assets in clinical trials. GCPj, March 2006, p.16-19. Also available from: http://www.kendle.com/media/ recent_editorials/Kendle_Latin_March_06.pdf
    • Hurley D. Leveraging Latin America assets in clinical trials. GCPj, March 2006, p.16-19. Also available from: http://www.kendle.com/media/ recent_editorials/Kendle_Latin_March_06.pdf
  • 13
    • 33644819768 scopus 로고    scopus 로고
    • A swift predominance of ex-US sites
    • Also available from
    • Getz KA. A swift predominance of ex-US sites. Appl Clin Trials. 2005;14(12):21-2. Also available from: www.actamagazine.com/ appliedclinicaltrials/article/articleDetail.jsp?id=261633.
    • (2005) Appl Clin Trials , vol.14 , Issue.12 , pp. 21-22
    • Getz, K.A.1
  • 15
    • 33645453483 scopus 로고    scopus 로고
    • Conflicts of interests and their repercussions on science
    • Goldim JR. Conflicts of interests and their repercussions on science. Rev Bras Psiquiatr. 2006;28(1):3-4.
    • (2006) Rev Bras Psiquiatr , vol.28 , Issue.1 , pp. 3-4
    • Goldim, J.R.1
  • 16
    • 33645504676 scopus 로고    scopus 로고
    • Learning from the TGN1412 trial
    • Goodyear M. Learning from the TGN1412 trial. BMJ. 2006;332(7543):677-8.
    • (2006) BMJ , vol.332 , Issue.7543 , pp. 677-678
    • Goodyear, M.1
  • 17
    • 0037022835 scopus 로고    scopus 로고
    • Coyle SL; Ethics and Human Rights Committee; American College of Physicians, American Society of Internal Medicine. Physician-Industry Relations. Par t 1: individual physicians. Par t 2: organizational issues. Ann Int Med. 2002;136(5):396-406
    • Coyle SL; Ethics and Human Rights Committee; American College of Physicians - American Society of Internal Medicine. Physician-Industry Relations. Par t 1: individual physicians. Par t 2: organizational issues. Ann Int Med. 2002;136(5):396-406.
  • 18
    • 85062138054 scopus 로고    scopus 로고
    • [No authors listed]. The UK clinical research network. [cited 2006 June14]. Available from: URL: www.clinicaldiscovery.com/readArticle.aspx? articleId=23.
    • [No authors listed]. The UK clinical research network. [cited 2006 June14]. Available from: URL: www.clinicaldiscovery.com/readArticle.aspx? articleId=23.
  • 21
    • 85062123262 scopus 로고    scopus 로고
    • Depoortere E, Legros D, Torreele E. Developing a needs-based and rational approach to identify neglected diseases and select R&D projects that could maximally impact treatment options. Working Group. Nov 2001. [cited 2006 July 22]. Available from: http://www.accessmed.msf.org/upload/ReportsandPublications/ 23920021528595/1-5.pdf.
    • Depoortere E, Legros D, Torreele E. Developing a needs-based and rational approach to identify neglected diseases and select R&D projects that could maximally impact treatment options. Working Group. Nov 2001. [cited 2006 July 22]. Available from: http://www.accessmed.msf.org/upload/ReportsandPublications/ 23920021528595/1-5.pdf.
  • 22
    • 85062131050 scopus 로고    scopus 로고
    • [No authors listed]. DNDi project pipeline 2005. [cited 2006 July 22]. Available from: http://www.dndi.org/newsletters/10/portfolio.htm.
    • [No authors listed]. DNDi project pipeline 2005. [cited 2006 July 22]. Available from: http://www.dndi.org/newsletters/10/portfolio.htm.
  • 24
    • 85062144195 scopus 로고    scopus 로고
    • Shorter E. A History of Psychiatry - From the era of the Asylum to the age of Prozac. New York: John Wiley & Sons, Inc; 1977.
    • Shorter E. A History of Psychiatry - From the era of the Asylum to the age of Prozac. New York: John Wiley & Sons, Inc; 1977.
  • 25
    • 0001475799 scopus 로고
    • Effect of chlorpromazine on the behaviour of chronically overactive psychotic patients
    • Elkes J, Elkes C. Effect of chlorpromazine on the behaviour of chronically overactive psychotic patients. Br Med J. 1954;2(4887):560-5.
    • (1954) Br Med J , vol.2 , Issue.4887 , pp. 560-565
    • Elkes, J.1    Elkes, C.2
  • 26
    • 0001587603 scopus 로고
    • The treatment of manic psychosis by the administration of lithium salts
    • Schou M, Juel-Nielsen N, Stromgren E, Voldby H. The treatment of manic psychosis by the administration of lithium salts. J Neurol Psychiatry. 1954;17(4):250-60.
    • (1954) J Neurol Psychiatry , vol.17 , Issue.4 , pp. 250-260
    • Schou, M.1    Juel-Nielsen, N.2    Stromgren, E.3    Voldby, H.4
  • 27
    • 0023812652 scopus 로고
    • Clozapine for the treatmentresistant schizophrenic. A double-blind comparison with chlorpromazine
    • Kane J, Honigfeld G, Singer J, Meltzer H. Clozapine for the treatmentresistant schizophrenic. A double-blind comparison with chlorpromazine. Arch Gen Psychiatry. 1988;45(9):789-96.
    • (1988) Arch Gen Psychiatry , vol.45 , Issue.9 , pp. 789-796
    • Kane, J.1    Honigfeld, G.2    Singer, J.3    Meltzer, H.4
  • 28
    • 33646018911 scopus 로고    scopus 로고
    • Academic psychiatry and the pharmaceutical industry
    • Ban T. Academic psychiatry and the pharmaceutical industry. Prog Psychopharmacol Biol Psychiatry. 2006;30:429-41.
    • (2006) Prog Psychopharmacol Biol Psychiatry , vol.30 , pp. 429-441
    • Ban, T.1
  • 30
    • 85062125178 scopus 로고    scopus 로고
    • Levels of Evidence and Grades of Recommendation
    • cite Nov 15] Available from
    • [No authors listed]. Levels of Evidence and Grades of Recommendation. Oxford Center for evidence-based medicine. [cite 2006 Nov 15] Available from: http://www.cebm.net/levels_of_evidence.asp.
    • (2006) Oxford Center for evidence-based medicine
  • 31
    • 33746116086 scopus 로고    scopus 로고
    • Is there place for placebo controlled trials in the treatment of affective disorders?
    • Fineberg NA, Gale TM, Hawley CJ. Is there place for placebo controlled trials in the treatment of affective disorders? Rev Bras Psiquiatr. 2006;28(2):89-90.
    • (2006) Rev Bras Psiquiatr , vol.28 , Issue.2 , pp. 89-90
    • Fineberg, N.A.1    Gale, T.M.2    Hawley, C.J.3
  • 32
    • 0034531939 scopus 로고    scopus 로고
    • Algumas recomendações para estudos com placebo
    • Elkis H, Gattaz WF. Algumas recomendações para estudos com placebo. Rev Bras Psiquiatr. 2000;22(4):153-4.
    • (2000) Rev Bras Psiquiatr , vol.22 , Issue.4 , pp. 153-154
    • Elkis, H.1    Gattaz, W.F.2
  • 33
    • 85062130730 scopus 로고    scopus 로고
    • Revivendo o antigo sermão da medicina com o efeito placebo
    • Cho HJ. Revivendo o antigo sermão da medicina com o efeito placebo. Rev Bras Psiquiatr. 2005;27(4):336-40.
    • (2005) Rev Bras Psiquiatr , vol.27 , Issue.4 , pp. 336-340
    • Cho, H.J.1
  • 36
    • 4544295352 scopus 로고    scopus 로고
    • De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB; International Committee of Medical Journals Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med. 2004;351(12):1250-1.
    • De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB; International Committee of Medical Journals Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med. 2004;351(12):1250-1.
  • 39
    • 0037267068 scopus 로고    scopus 로고
    • How important are comprehensive literature searches and the assessment of trial quality in systematic reviews? Empirical study
    • Egger M, Juni P, Bartlett C, Holenstein F, Sterne J. How important are comprehensive literature searches and the assessment of trial quality in systematic reviews? Empirical study. Health Technol Assess. 2003;7(1):1-76.
    • (2003) Health Technol Assess , vol.7 , Issue.1 , pp. 1-76
    • Egger, M.1    Juni, P.2    Bartlett, C.3    Holenstein, F.4    Sterne, J.5
  • 40
    • 0030720013 scopus 로고    scopus 로고
    • Meta-analysis: Principles and procedures
    • Egger M, Smith GD, Phillips AN. Meta-analysis: principles and procedures. BMJ. 1997;315(7121):1533-7.
    • (1997) BMJ , vol.315 , Issue.7121 , pp. 1533-1537
    • Egger, M.1    Smith, G.D.2    Phillips, A.N.3
  • 41
    • 85062140631 scopus 로고    scopus 로고
    • The Association of the British Pharmaceutical Industry
    • trials, cited July 29, Available from
    • [No authors listed]. The Association of the British Pharmaceutical Industry. TGN1412: Joint industry taskforce produces guidelines to improve conduct of early stage clinical trials. [cited 2006 July 29]. Available from: http://www.abpi.org.uk/press/press_releases_06/060724.asp.
    • (2006) Joint industry taskforce produces guidelines to improve conduct of early stage clinical , vol.TGN1412
  • 42
    • 85062133115 scopus 로고    scopus 로고
    • The Expert Scientific Group (ESG), Department of Health (UK), Government News Network
    • cited July 29, Available from
    • [No authors listed]. The Expert Scientific Group (ESG), Department of Health (UK), Government News Network. Interim report on phase 1 clinical trials published.[cited 2006 July 29]. Available from: http://www.gnn.gov.uk/ environmentfullDetail.asp?ReleaseID=216727&NewsAreaID=2& NavigatedFromDepartment=False.
    • (2006) Interim report on phase 1 clinical trials published
  • 43
    • 0031180478 scopus 로고    scopus 로고
    • Fair process: Managing in the Knowledge Economy
    • Kim WC, Mauborgne R. Fair process: managing in the Knowledge Economy. Harvard Business Review. 1997;65-75.
    • (1997) Harvard Business Review , pp. 65-75
    • Kim, W.C.1    Mauborgne, R.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.