Abstract
A multicentre clinical trial of a new injectable cephalosporin, ceftazidime, was designed based on the use of microcomputers for data entry and collection. The computer program was designed to ensure uniformity of data from different centres, to allow only patients defined in the clinical trial protocol to enter, and to ensure that all the data required were collected accurately. Both drug efficacy and safety were considered. Fifty-eight centres took part in this trial. Useful clinical and safety information was generated. Investigators found the microcomputer easy to operate. It was concluded that the use of microcomputers offers a framework for collecting clean, complete comprehensive patient data from a large number of patients. We believe that in the future, large multicentre clinical trials will routinely use the direct entry and data collection method.
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