The consumer's risk in clinical trials.

Abstract

In any formal statistical test of the null hypothesis (the statement that a population parameter is equal to a specific value), there are two possible types of error. Type 1 or alpha error has occurred if the investigator rejects the null hypothesis when it is true. For example, an experimental treatment is declared an advance over standard treatment when it is not. Type 2 or beta error has occurred if the null hypothesis is not rejected when it is false. In this case, the investigator concludes that the experimental treatment is no different than the standard when it actually is. The two types of error can be conceptualized, respectively, as the consumer's risk and the producer's risk. In many reports of clinical trial methodology, it is the producer's risk that is emphasized. It is understandable why producer's risk would be of concern to authors of clinical studies. There are, however, numerous potential sources of consumer's risk. It is the latter type of risk that is the primary subject of this report.