This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 643
Type: Invited
Date/Time: Thursday, August 5, 2010 : 10:30 AM to 12:20 PM
Sponsor: Statistical Society of Australia
Abstract - #306191
Title: Challenges in the Conduct of Clinical Trials in the Australasian Region
Author(s): Val Gebski*+
Companies: University of Sydney
Address: Locked Bag 77, Camperdown , Sydney, International, 1450, Australia
Keywords: Clinical trials ; Trial design ; Sample sizes ; Multi-national ; Health Services ; Meta-analysis
Abstract:

Multi-national clinical trials present unique challenges if the countries to be involved in the study differ in language, culture and health services delivery and practice. Potential reasons for different treatment effects in different countries include: (i) Patient and disease characteristics such as race, genetic factors, diet; (ii) treatment delivery/quality such as surgery, complex behavioural interventions;(iii) assessment of outcome including frequency of monitoring, clinical tests, interpretation of criteria for assessment, quality of life scores.

Another challenge is the small sample sizes individual regions can contribute to a clinical question for which the clinically significant difference is modest. As a result it can be more efficient to design individual studies examining surrogate outcomes and design the main study question as a prospective meta-analysis.


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