TITLE

Economic endpoints in clinical trials

AUTHOR(S)
Cook, John; Drummond, Michael; Heyse, Joseph F.
PUB. DATE
April 2004
SOURCE
Statistical Methods in Medical Research;Apr2004, Vol. 13 Issue 2, p157
SOURCE TYPE
Academic Journal
DOC. TYPE
journal article
ABSTRACT
Healthcare decision makers are increasingly requesting information on the cost and cost-effectiveness of new medicines at the time of product launch. In order to provide this information, data on healthcare resource utilization and, in some cases, costs, may be collected in clinical trials. In this paper, we discuss some of the issues statisticians need to address when it is appropriate to include these economic endpoints in the trial. Several design issues are discussed, including the alternative types of and methods for collecting economic endpoint data, sample size and generalizability. Alternative approaches in the analysis of resource utilization, cost and cost-effectiveness are also presented. Finally, several of the analytic approaches are applied to actual data from a clinical trial.
ACCESSION #
12916866

 

Related Articles

  • Drotrecogin alfa good value for severe sepsis in Germany.  // PharmacoEconomics & Outcomes News;4/10/2004, Issue 450, p5 

    Discusses research being done on the cost effectiveness of using drotrecogin alfa for the treatment of sepsis in Germany. Reference to a study by A. R. Nelson and colleagues, published in the December 2003 issue of the "Journal of Critical Care"; Purpose of developing a decision-analysis model;...

  • Evidence Based Medicine (EBM) in Practice: Applying Results of Cost-Effectiveness Analyses. Rubenstein, Joel H.; Inadomi, John M. // American Journal of Gastroenterology;Jun2006, Vol. 101 Issue 6, p1169 

    The article presents the use of cost-effectiveness analysis as a guide in making decisions pertaining to managing medical budgets and prioritizing the scheduling of patients. In the event of constrained resources, such tool is necessary to determine the best strategy on the basis of outcomes...

  • Women aged e 40 years bear assisted pregnancy costs.  // PharmacoEconomics & Outcomes News;4/8/2006, Issue 500, p22 

    Assisted reproductive techniques (ART) were found to be around "three to four times less cost-effective in women aged e 40 years than in younger women"; however, this age group only consumed 21% of the ART healthcare resources in Australia, report researchers from that country. They used a...

  • On the probability of cost-effectiveness using data from randomized clinical trials. Willan, Andrew R. // BMC Medical Research Methodology;2001, Vol. 1, p8 

    Background: Acceptability curves have been proposed for quantifying the probability that a treatment under investigation in a clinical trial is cost-effective. Various definitions and estimation methods have been proposed. Loosely speaking, all the definitions, Bayesian or otherwise, relate to...

  • Dementia case management effectiveness on health care costs and resource utilization: a systematic review of randomized controlled trials. PIMOUGUET, C.; LAVAUD, T.; DARTIGUES, J. F.; HELMER, C. // Journal of Nutrition, Health & Aging;Aug2010, Vol. 14 Issue 8, p669 

    The growing number of dementia patients leads to both policy, economic and health organization constraints. Many healthcare systems have developed case management programs in order to optimize dementia patients and caregivers care and services delivery. Nevertheless, to what extend case...

  • The pathway to physician reimbursement for cardiac implantable electronic devices (CIEDs): a history and brief synopsis. Roka, Attila; Schoenfeld, Mark // Journal of Interventional Cardiac Electrophysiology;Mar2013, Vol. 36 Issue 2, p137 

    Cardiac implantable electronic devices (CIEDs), despite their proven effectiveness in large clinical trials for a wide range of patients with arrhythmia and heart failure, are frequent targets for criticism regarding cost-efficiency and alleged overuse. Newer indications, such as sinus node...

  • Lifetime health effects and medical costs of integrated stroke services - a non-randomized controlled cluster-trial based life table approach. Baeten, Stefan A.; van Exel, N Job A.; Dirks, Maaike; Koopmanschap, Marc A.; Dippel, Diederik W. J.; Niessen, Louis W. // Cost Effectiveness & Resource Allocation;2010, Vol. 8, p21 

    Background: Economic evaluation of stroke services indicates that such services may lead to improved quality of life at affordable cost. The present study assesses lifetime health impact and cost consequences of stroke in an integrated service setting. Methods: The EDISSE study is a prospective...

  • Rotavirus Vaccine RIX4414 (Rotarixâ„¢). Plosker, Greg L. // PharmacoEconomics;2011, Vol. 29 Issue 5, p439 

    The most common cause of severe diarrhoea in infants and young children is rotavirus gastroenteritis (RVGE), which is associated with significant morbidity, healthcare resource use and direct and indirect costs in industrialized nations. The monovalent rotavirus vaccine RIX4414 (Rotarix_) is...

  • The costs of clinical trials. Fletcher, Robert H.; Fletcher, R H // JAMA: Journal of the American Medical Association;10/6/89, Vol. 262 Issue 13, p1842 

    Editorial. Focuses on the cost-effectiveness of clinical trials. Definition of fixed costs and effectiveness; Reasons why policymakers do not clamor for more spending on research; View that clinical trials are a bad investment at any price; Importance of value judgments on how to spend health...

Share

Read the Article

Courtesy of THE LIBRARY OF VIRGINIA

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics