In January 1995, the Pharmaceutical Research and Manufacturers of America (PhRMA) adopted a voluntary set of principles to provide guidance for its member companies on the conduct and evaluation of pharmacoeconomic research. The principles were prepared by a working group of pharmacoeconomic scientists from the PhRMA Task Force on the Economic Evaluation of Pharmaceuticals. The principles were reviewed by a panel of academic experts and outside reviewers at each stage of their development.
The PhRMA document consists of a set of broad principles that will foster high quality pharmacoeconomic research without impeding further methodological development of the field. Specific recommendations are offered in those methodological areas for which general agreement exists. However, no attempt was made to force a consensus for those methodological issues which have yet to be resolved.
The principles address methodology and reporting of research rather than sponsor-investigator relationships or conflict of interest issues, which have been addressed elsewhere. This approach is based on the belief that the scientific integrity of pharmacoeconomic research is best ensured through the soundness of the research methods used and the full disclosure and transparency of all methods, analyses and results.
Canadian Coordinating Office on Health Technology Assessment (CCOHTA). Guidelines for economic evaluation of pharmaceuticals. 1st ed. Ottawa: CCOHTA, 1994Google Scholar
Commonwealth Department of Health, Housing and Community Services. Guidelines for the pharmaceutical industry on preparation of submissions to the Pharmaceutical Benefits Advisory Committee: including submissions involving economic analyses. Canberra: Australian Government Publishing Service, 1992Google Scholar
Drummond M, Brandt A, Luce B, et al. Standardizing methodologies for economic evaluation in healthcare: practice, problems, and potential. Int J Technol Assess Health Care 1993; 9 (1): 26–36PubMedCrossRefGoogle Scholar
Drummond MF, Davies L. Economic analysis alongside clinical trials: revisiting the methodological issues. Int J Technol Assess Health Care 1991; 7 (4): 561–73PubMedCrossRefGoogle Scholar
Drummond ME. Economic evaluation of pharmaceuticals: science or marketing? PharmacoEconornics 1992; 1 (1): 8–13CrossRefGoogle Scholar
Freund DA, Dittus RS. Principles of pharmacoeconomic analysis of drug therapy. PharmacoEconomics 1992; 1 (1): 20–9PubMedCrossRefGoogle Scholar
Luce BR, Simpson K. Methods of cost effectiveness analysis: areas of consensus and debate. Report prepared for Pharmaceutical Manufacturers Association, April 22, 1993Google Scholar
Luce BR. Cost-effectiveness analysis: obstacles to standardisation and its use in regulating pharmaceuticals. PharmacoEconomics 1993; 3 (1): 1–9PubMedCrossRefGoogle Scholar
Bootman JL, Larson LN, McGhan WF, et al. Pharmacoeconomic research and clinical trials: concepts and issues. DICP Ann Pharmacother 1989; 23: 693–7Google Scholar
Johannesson M, Johansson P-O, Jonsson B. Economic evaluation of drug therapy: a review of the contingent valuation method. PharmacoEconomics 1992; 1 (5): 325–37PubMedCrossRefGoogle Scholar
Eisenberg JM. Clinical economics: a guide to the economic analysis of clinical practices. JAMA 1989; 262 (20): 2879–86PubMedCrossRefGoogle Scholar
Hillman AL, Eisenberg JM, Pauly MV, et al. Avoiding bias in the conduct and reporting of cost-effectiveness research sponsored by pharmaceutical companies. N Engl J Med 1991; 324 (19): 1362–5PubMedCrossRefGoogle Scholar
Ontario Ministry of Health. Ontario guidelines for economic analysis of pharmaceutical products. Toronto: Queen’s Printer for Ontario, 1994Google Scholar