Multinational megatrials or new approaches in clinical trials

Abstract

Background of study. Clinical trial investigators and sponsors often underestimate the level of screening necessary to yield a suf®cient inclusion number. Without the resources to manage this, inclusion criteria can be compromised in an effort to recruit from a modest pool of potential subjects.Objective. We show the use of intensive advertising for subject recruitment.Design. Small and large advertisements for a trial of a relatively common indication with wide inclusion and exclusion criteria were placed consecutively in national newspapers, and were broadcast on commercial radio stations.Results. To recruit 145 subjects for the trial, over 500 individual screens from a total of more than 7000 responders were necessary. Observations revealed that more potential subjects responded to the large ads and radio broadcasts, while the response to the small ads was poor.Conclusion. Intensive advertising strategies can positively in¯uence the rate of enrolment and should be considered a necessary expense by any large trial investigator. Depending on demographic targeting factors and trial requirements, different media may be more ef®cient. A critical review of the screening volumes required for successful subject inclusion is necessary.