Computers in Drug Safety Evaluation

Abstract

There has been increased emphasis on accurate data collection during drug safety studies. This emphasis, principally from the proposed Good Laboratory Practices Act (GLP), was directed at keeping accurate records of the millions of separate pieces of preclinical test data and reporting them in a logical, complete, and cohesive form. When we, at Hoechst-Roussel, studied our problems of data collection, storage and retrieval, we decided that a computer would be highly useful in helping perform our record keeping. We set certain goals for the computer system. Among these were: -it had to be simple, understandable and user oriented. -it had to use a free form natural language format. -it had to be one hundred percent accurate. Data could not be lost, misfiled, or improperly manipulated. -it had to be secure and protected from unauthorized use. -it had to be economical to produce and operate. -it had to save significant amounts of time in performing drug safety evaluations. -the computer had to be able to accept a number of users' input simultaneously both in key-entry (typed in on a typewriter-like keyboard) and machine direct on-line modes. A system was constructed along these guidelines. Hoechst chose the DEC PDP11/55 minicomputer (Digital Equipment Corpora-'$ tion, Maynard, MA) as the computer mainframe. This unit, together with two RK05 and one RP06 disk storage units, has an operating capacity of 96,000 words (2 bytes = 1 word) of which 16,000 words are in a fast bipolar memory. The disk storage units enable long term