Document Detail


Clinical development of atypical antipsychotics: research design and evaluation. Collaborative Working Group on Clinical Trial Evaluations.
MedLine Citation:
PMID:  9766614     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Clinical trials support the efficacy and safety of new drugs on the market. They provide the United States Food and Drug Administration with the information needed to approve an Investigational New Drug application and are the basis for package inserts provided by the manufacturers that guide clinicians in the use of a new drug. Because clinical trials are vital to the effective and safe use of new drugs, it is important to understand who participates in them, what questions are answered by clinical trials, and what questions are raised. The reader who asks the proper questions about issues such as methodology, affiliations of the investigators, statistical analyses performed, location of study centers, and study populations will derive the most information from the report of a clinical trial.
Authors:
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Publication Detail:
Type:  Journal Article; Multicenter Study; Review    
Journal Detail:
Title:  The Journal of clinical psychiatry     Volume:  59 Suppl 12     ISSN:  0160-6689     ISO Abbreviation:  J Clin Psychiatry     Publication Date:  1998  
Date Detail:
Created Date:  1998-10-20     Completed Date:  1998-10-20     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7801243     Medline TA:  J Clin Psychiatry     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  10-6     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adult
Antipsychotic Agents / adverse effects,  economics,  therapeutic use*
Clinical Trials as Topic / methods*,  standards*,  statistics & numerical data
Cross-Cultural Comparison
Drug Administration Schedule
Drug Approval / legislation & jurisprudence
Drugs, Investigational / adverse effects,  economics,  therapeutic use
Europe
Female
Humans
Male
Placebos
Psychiatric Status Rating Scales
Research Design / standards,  statistics & numerical data
Schizophrenia / drug therapy
United States
United States Food and Drug Administration
Chemical
Reg. No./Substance:
0/Antipsychotic Agents; 0/Drugs, Investigational; 0/Placebos

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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