Document Detail


Are there circumstances in which phase 2 study results should be practice-changing?
MedLine Citation:
PMID:  18024669     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
New pharmaceuticals, innovative combinations of approved agents, and novel treatment modalities have resulted in a marked increase in the need for clinical trials. Evidence for treatment efficacy is best derived from large phase 3 randomized, controlled clinical trials. However, phase 3 investigations are lengthy and expensive, and consume patient resources. Furthermore, some diseases and treatment indications are rare, and adequate numbers of patients for a definitive phase 3 trial do not exist. Consequently, it is imperative for clinicians to understand phase 2 trial design, since their interpretation is required to apply the findings in clinical practice appropriately. The complexity of phase 2 studies is explored, including unique designs, possible use of randomization, and other key elements necessary for interpretation of phase 2 trials. Specific examples and application of these concepts are discussed in this review.
Authors:
Marcie R Tomblyn; J Douglas Rizzo
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Hematology / the Education Program of the American Society of Hematology. American Society of Hematology. Education Program     Volume:  -     ISSN:  1520-4391     ISO Abbreviation:  Hematology Am Soc Hematol Educ Program     Publication Date:  2007  
Date Detail:
Created Date:  2007-11-20     Completed Date:  2009-07-14     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100890099     Medline TA:  Hematology Am Soc Hematol Educ Program     Country:  United States    
Other Details:
Languages:  eng     Pagination:  489-92     Citation Subset:  IM    
Affiliation:
Dept. of Hematology, Oncology & Transplantation, University of Minnesota, 420 Delaware St., SE, MMC 480, Minneapolis MN 55455, USA. tombl001@umn.edu
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MeSH Terms
Descriptor/Qualifier:
Clinical Trials, Phase II as Topic*
Research Design

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


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