The Development of Standard Economic Datasets for use in the Economic Evaluation of Medicines
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0092-86 I5/2OO0 Copyright 0 2000 Drug Information Association Inc.
THE DEVELOPMENT OF STANDARD ECONOMIC DATASETS FOR USE IN THE ECONOMIC EVALUATION OF MEDICINES MARTINE. BACKHOUSE Research Triangle Institute, Manchester, United Kingdom
ARI GNANASAKTHY Novartis Pharma AG, Basel, Switzerland
KEVINA. SCHULMAN Center for Clinical and Genetic Economics, Duke University, Durham, North Carolina
RONAKEHURST School of Health and Related Research, University of Sheffield, Sheffield, United Kingdom
HENRYGLICK Leonard David Institute of Health Economics. University of Pennsylvania, Philadelphia, Pennsylvania
Regulatory imperatives and competitive forces have led pharmaceutical companies to focus on extending the scope of their randomized controlled trials (RCTs) to collect data to address economic as well as safety and eficacy questions. To guide researchers, a significant literature exists on various methodological aspects of conducting economic evaluations within an RCT framework. Little has been published, however, about data handling issues surrounding the management of the economic data collection effort. Thus, the objective of this paper is to present an overview of a project conducted in order to tackle various aspects of the economic data managementprocess with a view to improving the eficiency of study conduct. The project outputs include case report forms (CRF), guidelines for CRF completion, and templates for producing statistical analysis plans and study protocols. Directions for further research are highlighted. Key Words: Randomized controlled trials; Economic evaluation; Data management; Case report forms; Statistical analysis
INTRODUCTION I N RECENT YEARS, there has been a proliferation of economic assessments of health This paper is based on a presentation made at the DIA meeting “Economic Assessment in Clinical Trials,” November 6-7, 1997, Hilton Head, South Carolina. Reprint address: Martin E. Backhouse, Research Triangle Institute, Williams House, Manchester Science Park, Lloyd Street North, Manchester MI5 6SE, England.
care interventions generally, and of medicines in particular (1,2,3). The data required for economic analysis can be generated in a number of ways. They can be collected prospectively or retrospectively in either a randomized or observational study framework (4). Alternatively, a variety of modelling techniques can be used which involve the synthesis of sampled data and judgment data from a number of sources (5). Regulatory imperatives and competitive forces,
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M. E. Backhouse, A. Gnunasakthy, K. A. Schulmun, R. Akehurst, and H. GIick
however, have led pharmaceutical companies to focus on extending the scope of their randomized controlled trials to collect data to address economic as well as safety and efficacy questions (6,7). That focus has contributed to the emergence of a substantive literature pertaining to the conduct of economic evaluations within an RCT framework. Numerous examples of appli
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