METHOD, SYSTEM AND DATABASE FOR PERFORMING POST-MARKETING SURVEILLANCE AND EVALUATION OF DRUGS

摘要

A system and a method for surveying and assessing the contribution of drugsrisks ofadverse events, comprising a) identification and studying a plurality of case-groups ofdifferent categories of adverse events, each case of a given case-group beingfaced witha given adverse event; a pool of potential referents identified regardless ofa previousmedical history thereof; and a large number of drugs and vaccines used by thecasesand the potential referents; b) selecting controls sampled from the pool ofpotentialreferents according to predetermined criteria; c) matching the controls tospecific casesof the case-groups; and d) conducting statistical analyses by comparing casesandcontrols to identify drugs that are susceptible to be associated with amodified risk of atleast one of the adverse events and factors associated with this risk; whereinthe stepsa) to d) are performed on a systematic prospective on-going plan