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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS

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THE ESSENCE OF THE GUIDELINES presented here—start with your reports, enter the data directly into the computer, validate on entry, and monitor your results continuously—first appeared in a newsletter I edited in the mid-1980s.The reactions of readers then ranged from tepid to outwardly hostile:“We can’t afford to give every physician a computer,” raged one data manager, ignoring the $10,000 per patient that is the normal minimal expense for clinical data.“What will become of all the people we’ve trained as encoders?” moaned another months before the furious downsizing that characterized the late ’80s

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