Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs

Chapter 16

Clinical Trial Misconduct

Drummond Rennie

16.1 The Scope of this Article

The purpose of clinical trials of interventions is to obtain unbiased, relevant, and reliable information on the value of the interventions [1]. Many ethical problems can occur during a trial. It can be designed incorrectly, for example, so that the results of a placebo-controlled trial on a me-too drug are worthless to the clinician who wants to know whether it represents an improvement over the best already available. Randomization can be broken and concealment made inadequate. The trial can be underpowered so that the research participants are put at risk without any hope of obtaining results of value to mankind. The trial may be stopped early by the sponsor for financial reasons [2], the results of the trial can be buried, or the same results can be reported repeatedly by different authors without cross-referencing [3], resulting in publication bias or distortion of the published literature. These and other such actions are, to varying degrees, unethical, and all of them have at one time or another been labeled research or scientific misconduct [4], but in the United States at least, they fall outside the federal definition of research misconduct and no one would be found guilty of misconduct for such acts alone.

It is particularly useful to look at the history and present situation of scientific misconduct in the United States to see how this came about, because it was in the United States ...