A computerized patient registration and treatment randomization system for multi-institutional clinical trials.

Computerized registration and randomization for a cooperative clinical trials group is a useful addition to its data gathering and managing process. An automated system eliminates unnecessary paperwork, allows more sophisticated randomization algorithms to be implemented, and makes available a variety of computer-generated reports such as confirmation of registration forms, accrual results, and other statistical tables. This paper describes the design and implementation of such a system for a relatively large cooperative group, the Eastern Cooperative Oncology Group (ECOG), as well as gives general recommendations for conversion of a manual registration and randomization process to an automated one. Our general interactive system, known as PRS for Patient Randomization System, was designed to be easily expandable as its functions increase over time, and transportable to other clinical trials settings.