Good Clinical Practice Q&A: Focus on Dual Enrollment

摘要

According to the draft FDA guidance on informed consent from July 2014, the FDA strongly discourages this practice, but there is no regulation that prohibits it. According to the guidance, enrollment in more than one clinical investigation could increase risks to subjects, particularly because they may be exposed to more than one investigational product for which the safety profile may not be well understood. Subjects may also find it difficult to understand all the risks and proposed benefits, much less meet the demands, of multiple protocols. Sponsors also generally include prohibitions related to the use of concomitant medications in the protocol or restrict (via exclusion criteria) inclusion of subjects who have participated in another clinical investigation within a specified period of time (for example, the washout period before a subject can enroll in a new clinical investigation). Implied in the prohibitions on concomitant medications is the idea that subjects should not participate in more than one clinical investigation.