Disclosing the Possibility of Early Trial Termination to Prospective Clinical Trial Participants

Many participants are motivated to enroll in clinical trials both for the prospect of individual benefit and for altruistic reasons. When a clinical trial is stopped early, it may significantly alter the participant trial experience and impact the likelihood that the trial will contribute to generalizable knowledge. Despite the frequency with which trials are stopped early, occurring in ten to thirty percent of trials, participants are rarely informed of this possibility during the informed consent process. Therefore, they are not given the opportunity to take this into consideration in their decision-making process. To redress this, we advance a framework for disclosing the possibility of early trial termination to prospective participants, arguing that disclosure is justified because it supports participant decision-making and promotes transparency and trust in the research enterprise.