| Are there circumstances in which phase 2 study results should be practice-changing? | |
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MedLine Citation:
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PMID: 18024669 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Marcie R Tomblyn; J Douglas Rizzo |
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Publication Detail:
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Type: Journal Article; Review |
Journal Detail:
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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:
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Created Date: 2007-11-20 Completed Date: 2009-07-14 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100890099 Medline TA: Hematology Am Soc Hematol Educ Program Country: United States |
Other Details:
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Languages: eng Pagination: 489-92 Citation Subset: IM |
Affiliation:
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Dept. of Hematology, Oncology & Transplantation, University of Minnesota, 420 Delaware St., SE, MMC 480, Minneapolis MN 55455, USA. tombl001@umn.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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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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