A Strategy for Collecting Pharmacoeconomic Data During Phase II/III Clinical Trials
- 36 Downloads
This article presents an overview of the process and organisational aspects required to support the collection of pharmacoeconomic (PE) data during phase II and phase III clinical trials of pharmaceutical products. The process described requires early involvement of the PE study team in clinical trials design and planning, as well as continuing close collaboration between the PE study team and the clinical study team as the data collection plans are implemented.
Adequate resources must be made available for staffing and funding the PE component of data collection and analysis. If the suggested procedures are adequately resourced and implemented, the result should be a comprehensive, complete and accurate database that will allow the PE study team to characterise the economic value of the new drug at the same time as the clinical study team characterise its safety and efficacy. Integrated clinical and economic evaluations are essential for the appropriate use of pharmaceutical products in rapidly changing markets.
KeywordsAdis International Limited Case Report Form Source Document Data Collection Effort Medical Bill
Unable to display preview. Download preview PDF.
- 1.Laupacis A, Feeny D, Detsky A, et al. How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations. Can Med Assoc J 1992; 146: 473–81Google Scholar
- 2.Evans D, Freund D, Dittus R, et al. The use of economic analysis as a basis for inclusion of pharmaceutical products on the pharmaceutical benefits scheme. Canberra: Department of Health, Housing and Community Services, 1990Google Scholar
- 3.Schulman K. The use of evaluation in pharmaceutical reimbursement decisions in the United States. In: Schubert F, editor. Proceedings of the Canadian Collaborative Workshop on Pharmacoeconomics; 1993 Jun 21-22; Quebec. Princeton (NJ): Excerpta Medica Inc., 1993: 19–23Google Scholar
- 4.Eisenberg J, Glick H, Schulman K, et al. Pharmacoeconomics: economic evaluation of pharmaceuticals. In: Strom B, editor. Pharmacoepidemiology. 2nd ed. Chichester: John Wiley and Sons Ltd, 1994Google Scholar
- 6.Schulman K, Glick H, Buxton M, et al. Economic assessment of the FIRST study: a prospective multinational phase III study. Controlled Clin Trials. In pressGoogle Scholar
- 11.Task Force on Principles for Economic Analysis of Health Care Technology. Economic analysis of health care technology: a report on principles. Ann Intern Med 1995; 122: 61–70Google Scholar
- 13.De Nino L, Mulrow C, Gerety M, et al. Problems in interpreting cost effectiveness in clinical trials: experimental versus implementation costs. Online J Curr Clin Trials 1993 Apr 10; Document no. 44Google Scholar