Who Conducts Drug Effectiveness Analyses?
A drug product is approved for sale in Canada based on demonstration of safety and efficacy in clinical trials. However clinical trials, in which a drug treatment is administered to a limited, select group of compliant patients who meet specific criteria, are not necessarily representative of the real world. The measures of safety and efficacy upon which market approval is based, may not reflect the effectiveness of a drug product within a real world setting. Furthermore, given that most available information is based on proprietary data owned by the products’ sponsors – either the patent holder or drug manufacturer – the issue of objectiveness of information on drug product effectiveness is often raised. Options for the development of objective information have been explored in Canada in the past. For example, in 1993 a recommendation was made to the Federal/Provincial/Territorial (F/P/T) deputy ministers of health to create a Canadian agency for pharmaceutical information assessment
