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An Insider’s Guide to Clinical Trials$
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Curtis L Meinert

Print publication date: 2011

Print ISBN-13: 9780199742967

Published to Oxford Scholarship Online: September 2011

DOI: 10.1093/acprof:oso/9780199742967.001.0001

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An Insider’s Guide to Clinical Trials
Author(s):

Curtis L. Meinert

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780199742967.003.0019

This chapter considers the factors behind the conflicting results of clinical trials. The fact is that truth in medicine is elusive and fleeting. That which is “truth” today is passé tomorrow. The tried-and-true method of coming to what we accept as “truth” in science is by replication. However replication, in the strict sense of usage, is impossible in trials. No two trials are the same. The enrollment criteria will differ, the data collection schedules will differ, the treatment protocols will differ, even the treatments may be different. Hence, a single trial that reproduces a positive result seen in a previous trial is not sufficient to establish the value of that treatment. It takes multiple trials, usually spanning a period of years if not decades. There is no “trial master” in the sky. There is nobody to ensure a stream of trials until a consensus view develops. Nor is there anyone to shut off trials once the “answer is in.” Replication becomes duplication when the answer is in. But, when is that point reached? There is no bright line of demarcation.

Keywords:   clinical trials, medical research, treatment, truth, replication

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