OMERACT II : the biologics perspective.
Outcome measures in rheumatoid arthritis clinical trials. III : Health economics. Ottawa CAN, 1994/06/30.
The development of biologic agents for the treatment of rheumatic diseases will necessitate inclusion of pharmacoeconomic analyses in the phase III trials.
These products are expensive to manufacture, administer, and monitor.
Typically, they require parenteral administration and regular monitoring.
Often the duration of benefit is brief ; although they may effectively serve as « induction therapy. » It will be necessary to prospectively collect information about its costs (both direct and indirect) and the costs of alternative treatments.
In the multicenter clinical trials for approval, patients'opinions about their health status, quality of life, and the treatment itself must be sought.
Use of a health utilities instrument will allow comparison of different therapeutic interventions.
The promise of specifically targeting disregulated immune responses without altering underlying normal immune function makes biologic agents uniquely attractive for use in an early disease population.
It will therefore be important to identify those indirect costs saved or gained by maintaining function and work capacity, as well as the direct (and indirect) costs incurred by treatment associated toxicities.
Recognizing that all clinical trials are imperfect models of current medical practice, it will be necessary to analyze trial data in the context of additional demographic and epidemiologic information about the disease and currently available tr.
Mots-clés Pascal : Evaluation, Essai clinique, Méthodologie, Economie santé
Mots-clés Pascal anglais : Evaluation, Clinical trial, Methodology, Health economy
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 95-0423535
Code Inist : 002B30A01C. Création : 01/03/1996.