Methodological considerations in the design and implementation of clinical trials.


Journal Article

OBJECTIVES: To review study design issues related to clinical trials led by oncology nurses, with special attention to those conducted within the cooperative group setting; to emphasize the importance of the statistician's role in the process of clinical trials. DATA SOURCES: Studies available at using experimental designs that have been published in peer-reviewed journals; cooperative group trials are highlighted. CONCLUSION: The clinical trial is a primary means to test intervention efficacy. A properly designed and powered study with clear and measurable objectives is as important as the intervention itself. IMPLICATIONS FOR NURSING PRACTICE: Collaboration among the study team, including the statistician, is central in developing and conducting appropriately designed studies. For optimal results, collaboration is an ongoing process that should begin early on.

Full Text

Duke Authors

Cited Authors

  • Cirrincione, CT; Lavoie Smith, EM; Pang, H

Published Date

  • February 2014

Published In

Volume / Issue

  • 30 / 1

Start / End Page

  • 74 - 79

PubMed ID

  • 24559783

Pubmed Central ID

  • 24559783

Electronic International Standard Serial Number (EISSN)

  • 1878-3449

Digital Object Identifier (DOI)

  • 10.1016/j.soncn.2013.12.011


  • eng

Conference Location

  • United States