Rittenhouse B; International Society of Technology Assessment in Health Care. Meeting.
Abstr Int Soc Technol Assess Health Care Meet. 1993; 9: 76.
School of Pharmacy, The University of North Carolina, Chapel Hill 27599.
Clinical trials impose a set of rigid procedures on both clinicians and subjects. In particular, trials exclude patients who are unlikely to benefit from treatment. Such limitations do not reflect the probable actual pattern of use of the product once it is marketed. It is that pattern of use that is most relevant for economic assessment. This study presents a rudimentary economic model of a product (HA-1A) for the treatment of gram negative bacteremic patients. In one version, the criteria for administering the product are the relatively strict ones used in the published results from the only reported clinical trial. In another version, looser criteria reflect research that suggests the likely administration of the product in the absence of strict guidelines. This research suggests that not only is the sample of gram negative bacteremic patients used in the trial not representative (an overestimate) of the bacteremic population, but, in practice, many patients who are not in fact bacteremic would also be expected to (inappropriately) receive the drug. The significant difference in results between these two versions indicates (1) the importance of guidelines in predicting both health and economic outcomes and (2) the problems with using clinical trials and methods appropriate for answering one set of questions--efficacy and safety--to make inferences about a different set of issues--the performance of treatments in practice.
Publication Types:
Keywords:
- Clinical Trials as Topic
- Evaluation Studies
- Guidelines as Topic
- Humans
- Models, Economic
- Quality Control
- economics
- methods
- standards
- therapy
- hsrmtgs
Other ID:
UI: 102211471
From Meeting Abstracts