PC-BASED METHODS FOR MONITORING ONGOING CLINICAL TRIALS

PHASE III HUMAN ONCOLOGY TRIALS SHOULD BE STOPPED AS SOON ASPOSSIBLE IF THERE IS CLEAR EVIDENCE THAT ONE TREATMENT IS SUPERIOR TO THE OTHERS OR THAT NO TREATMENT WILL EMERGE AS SUPERIOR. QUANTECH, INC. PROPOSES TO STUDY STATISTICAL METHODS FOR THE EARLY STOPPING OF SUCH TRIALS AND TO IMPLEMENT THESE METHODS WITHIN A MICROCOMPUTER PACKAGE FOR INTERIM CLINICAL TRIAL MONITORING. IN ADDITION TO A SELECTION OF GROUP SEQUENTIAL METHODS FOR EARLY STOPPING, THE PACKAGE WILL DISPLAY ANCILLARY DATA USEFUL TO STATISTICIANS, CLINICIANS, AND ETHICISTS CONCERNED WITH MONITORING AN ONGOING STUDY. BY USING COMMERCIAL SOFTWARE FOR A DISTRIBUTED DATA SYSTEM, REMOTE SITES WILL SWIFTLY BE ABLE TO ENTER AND DISPLAY CRITICAL OUTCOME AND TOXICITY DATARELEVANT TO AN EARLY STOPPING DECISION. THE PHASE I STUDY WILL BEGIN WITH A COMPARISON, BY COMPUTER SIMULATION, OF PROPOSALS FOR GROUP SEQUENTIAL METHODS. CRITERIA TO BE COMPARED INCLUDE POWER, SAMPLE SIZE AT STOPPING, AND THE ALLOCATION OF TYPE I ERRORS AT EACH POSSIBLE STOPPING POINT. THE PROPOSED METHODS WILL THEN BE APPLIED TO REAL DATA FROM ONCOLOGY TRIALS TO SEE IF DIFFERENT METHODS MIGHT HAVE LED TO DIFFERENT DECISIONS. DURING PHASE I, A COMPUTER SYSTEM CONTAINING A VARIETY OF STATISTICAL FEATURES FOR INTERIM MONITORING OF TRIALS WILL BE DESIGNED AND IMPLEMENTED IN A PROTOTYPE SYSTEM.