The use of placebo-controlled clinical trials for the approval of psychiatric drugs: Part II - Ethical considerations related to the individual participant

Psychiatry

Volumn 6, Issue 12, 2009, Pages 19-25

  Feifel, David ^a  

^a UCSD MEDICAL CENTER   (United States)

Author keywords

Clinical trials; Ethics; Placebo; Study guidelines

Indexed keywords

PLACEBO;

ARTICLE; CLINICAL TRIAL; DIAGNOSTIC PROCEDURE; DISEASE EXACERBATION; ETHICS; GENERAL CONDITION IMPROVEMENT; HEALTH CARE COST; HOSPITALIZATION; HUMAN; INFORMED CONSENT; MENTAL DISEASE; METHODOLOGY; PATIENT MONITORING; PRACTICE GUIDELINE; PSYCHIATRIC TREATMENT; SCHIZOPHRENIA; SCREENING;

EID: 77649136558     PISSN: 15505952     EISSN: 15555194     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. Feifel D. The use of placebo-controlled clinical trials for the approval of psychiatric drugs: part I-statistics and the case for the "greater good." Psychiatry (Edgmont). 2009;6(3):41-43.
2. Candilis PJ, Fletcher KE, Geppert CM, et al. A direct comparison of research decision-making capacity: schizophrenia/schizoaffective, medically ill, and non-ill subjects. Schizophr Res. 2008 Feb;99(1-3):350-358.
3. Carpenter WT Jr, Gold JM, Lahti AC, et al. Decisional capacity for informed consent in schizophrenia research. Arch Gen Psychiatry. 2000;57(6):533-538.
4. Jeste DV, Palmer BW, Appelbaum PS, et al. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007;64(8):966-974.
5. 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. 2008 Aug 22. [Epub ahead of print].
6. 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.
7. World Health Organization. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. WHO Technical Report Series. 1995;850:Annex 3.