Statistical Challenges in the Evaluation of Treatments for Small Patient Populations-Reference-Cited by-同舟云学术

Statistical Challenges in the Evaluation of Treatments for Small Patient Populations

Published:2013-03-27 Issue:178 Volume:5 Page:
ISSN:1946-6234
Container-title:Science Translational Medicine
language:en
Short-container-title:Sci. Transl. Med.

Author:

Korn Edward L.¹,McShane Lisa M.¹,Freidlin Boris¹

Affiliation:

1. Biometric Research Branch, MSC 9735, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA.

Abstract

Creative clinical trial designs can help to address the statistical challenges associated with small patient populations.

Publisher

American Association for the Advancement of Science (AAAS)

Subject

General Medicine

Reference97 articles.

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3. European Medicines Agency Guideline on clinical trials in small populations; www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003615.pdf.

4. Institute of Medicine Small Clinical Trials: Issues and Challenges C. H. Evans S. T. Ildstat Eds. (National Academy Press Washington DC 2001); http://www.nap.edu/catalog/10078.html.

5. Office of Rare Diseases Research (NIH) and Office of Orphan Products Development (FDA) The science of small clinical trials lecture series; http://videocast.nih.gov/podcasts.asp?c=88.

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