HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Citation Map Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Tomblyn, M. R. Articles by Rizzo, J. D. Search for Related Content PubMed PubMed Citation Articles by Tomblyn, M. R. Articles by Rizzo, J. D. Social Bookmarking                   What's this?

Are There Circumstances in Which Phase 2 Study Results Should Be Practice-Changing?

Correspondence: Marcie Tomblyn, MD, MS, Dept. of Hematology, Oncology & Transplantation, University of Minnesota, 420 Delaware St., SE, MMC 480, Minneapolis MN 55455; phone (612) 624–5109; fax (612) 625–6919; tombl001{at}umn.edu

Abstract

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.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?