Distinctions between fraud, bias, errors, misunderstanding, and incompetence

Randomized clinical trials are challenging not only in their design and analysis, but in their conduct as well. Despite the best intentions and efforts, problems often arise in the conduct of trials, including errors, misunderstandings, and bias. In some instances, key players in a trial may discover that they are not able or competent to meet requirements of the study. In a few cases, fraudulent activity occurs. While none of these problems is desirable, randomized clinical trials are usually found sufficiently robust by many key individuals to produce valid results. Other problems are not tolerable. Confusion may arise among scientists, scientific and lay press, and the public about the distinctions between these areas and their implications. We shall try to define these problems and illustrate their impact through a series of examples. (C) Elsevier Science Inc. 1997.