Research article summary (published 30 Dec 2003):

Statistics in clinical trials.

Full Abstract

Statistical developments over the past several years are described in this review. Efforts in phase I studies have focused on efficient estimation of maximum tolerated dose. Issues investigated for phase II trials include incorporation of multiple endpoints and randomization. For phase III trials, methods to reduce time or use the sample size more efficiently have been investigated. However, design innovations come with costs, including possible increased risk of incorrect conclusions. Other recent challenging statistical developments in clinical trials relate to use of complementary outcomes such as quality of life and to associated biologic questions, including the emergence of the field of genomics.

Author information

Author/s: Green, Stephanie J (SJ); Pauler, Donna K (DK);

Affiliation: Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North MP-557, Seattle, WA 98109, USA. stephani(-atsign-)crab.org

Journal and publication information

Publication Type: Journal Article; Review

Journal: Current oncology reports (Curr Oncol Rep), published in United States. (Language: eng)

Reference: 2004-Jan; vol 6 (issue 1) : pp 36-41

Dates: Created 2003/12/10; Completed 2004/11/08; Revised 2007/11/15;

PMID: 14664759, status: MEDLINE (last retrieval date: 2/18/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Clinical Trials as Topic - methods; statistics & numerical data Clinical Trials, Phase I as Topic - methods; statistics & numerical data Clinical Trials, Phase II as Topic - methods; statistics & numerical data Clinical Trials, Phase III as Topic - methods; statistics & numerical data Endpoint Determination - methods; statistics & numerical data

Endpoint Determination - methods; statistics & numerical data Humans Neoplasms - therapy Quality of Life Research Design - statistics & numerical data

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