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Health economic evaluations alongside clinical trials: A review of study protocols at the Swedish Medical Products Agency

Published online by Cambridge University Press:  19 June 2007

Anne Lindfors ,
Nils Feltelius  and
Jonas Lundkvist
Anne Lindfors
Affiliation:
Karolinska Institutet
Nils Feltelius
Affiliation:
Karolinska Institutet and Medical Products Agency
Jonas Lundkvist
Affiliation:
Karolinska Institutet
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Abstract

Objectives: Conducting economic evaluation in the context of clinical studies is common but has been the subject of extensive discussion due to its limitations. Various standard approaches and guidelines how such studies should be conducted have been proposed, but there is very limited information available about how common these studies are, what type of data that is collected, and how the quality of the protocols compares to the suggested standards. This study examines the prevalence and study design of health economic evaluations conducted alongside clinical trials in Sweden between 1995 and 2005.

Methods: A systematic assessment of clinical trial protocols that had arrived as applications to the Medical Products Agency between 1995 and 2005 was performed. Only protocols arriving during the first half of odd years within the time period were included.

Results: A total number of 680 protocols from 1995 to 2005 were examined, and among them, 14.4 percent included a health economic part. With the exception of year 2001, a trend toward an increased prevalence of economic evaluations next to clinical trials can be seen.

Conclusions: This study shows that economic evaluations alongside clinical trials are becoming more common, although most trials still lack a health economic part of the protocol. The information about the economic evaluation provided in the protocols is in many cases scarce, possibly due to the fact that there currently are no generally accepted and applied guidelines for economic evaluations in clinical trial protocols. Introducing requirements for detailed study plans also for the economic evaluation should improve the quality of economic evaluations alongside clinical trials.

Keywords

PharmacoeconomicsPharmaceuticalsClinical trialsGovernment agencyPolicy development
Type
RESEARCH REPORTS
Information
International Journal of Technology Assessment in Health Care , Volume 23 , Issue 3 , July 2007 , pp. 392 - 396
Copyright
© 2007 Cambridge University Press

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References

Brauer CA, Neumann PJ. 2005 Quality-adjusted life years: How useful in medico economic studies. Fundam Clin Pharmacol. 19: 603– 607.Google Scholar
DiMasi JA, Caglarcan E, Wood-Armany M. 2001 Emerging role of pharmacoeconomics in the research and development decision-making process. Pharmacoeconomics. 19: 753– 766.Google Scholar
Drummond MF. 1998 A reappraisal of economic evaluation of pharmaceuticals. Science or marketing? Pharmacoeconomics. 14: 1– 9.Google Scholar
Healey M, Deverka P. 1999 Panel I: Methodological issues in pharmacoeconomic evaluations-clinical studies. Value Health. 2: 73– 77.Google Scholar
McGregor M, Caro JJ. 2006 QALYs: Are they helpful to decision makers? Pharmacoeconomics. 24: 947– 952.Google Scholar
O'Sullivan AK, Thompson D, Drummond MF. 2005 Collection of health-economic data alongside clinical trials: Is there a future for piggyback evaluations? Value Health. 8: 67– 79.Google Scholar
Pang F. 2002 Design, analysis and presentation of multinational economic studies. Pharmacoeconomics. 20: 75– 90.Google Scholar
Ramsey S, Willke R, Briggs A, et al. 2005 Good research practices for cost-effectiveness analysis alongside clinical trials: The ISPOR RCT-CEA Task Force Report. Value Health. 8: 521– 533.Google Scholar
Swedish Pharmaceuticals Benefits Board. Guidelines for economic evaluations. Available at: www.lfn.se.