METHODS FOR CONDUCTING A CLINICAL TRIAL

摘要

The present disclosure relates generally to methods for selecting subjects for a clinical trial and includes methods for conducting a clinical trial to study the efficacy and/or safety of a drug by selecting subjects, for inclusion in a subsequent double-blind treatment period of the clinical trial, that do not exhibit adverse events to the drug. Methods for conducting a clinical trial may comprise the following: (1) an open-label titration period, (2) an adjustable dose treatment period and (3) a fixed dose treatment period. Optionally, the clinical trial may comprise a washout period prior to the open-label titration period. Also provided are methods for doing business by selecting subjects for a clinical trial for a drug that do not exhibit adverse events to the drug. Such methods may generate, revenue by reducing the length of time required to complete the clinical trial, increasing the likelihood that the drug will obtain regulatory approval and/or reducing the length of time it takes to bring advance the drug to market.