Microcomputer voice-response telephone entry for balanced clinical trial randomization

Simple randomization of patients to treatment regimens in clinical trials can result in inbalance among stratum categories. Procedures that produce balance may lack randomness. Systems that are not deterministic yet produce balance are often extremely complex and are not easily performed by randomization clerks. A microcomputer-based voice-response system has been implemented that permits clinic staff to easily randomize patients in clinical trials despite the complexity of the algorithm. Data entry is accomplished by the use of Touch-Tone keys. Input prompts and regimen assignment are spoken by a commercially available voice synthesizer.