DATA MONITORING OF GLOBAL TRIALS: SOME GENERAL ISSUES AND A CASE STUDY
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*Susan Ellenberg, University of Pennsylvania 

Keywords: DMC, global trial, benefit-risk, monitoring, ethics

Global trials present special challenges to data monitoring committees (DMCs). Balancing ethical issues with scientific considerations is always in the remit of a DMC, but in a trial in which there may be widely varying perspectives on ethical considerations, finding this balancing can be difficult. A DMC for a global trial should ideally include members who are aware of and sensitive to these varying perspectives and can incorporate them into discussions and evaluations of the emerging data. In some cases, especially when trials are conducted in developing countries, practical and financial considerations may also arise in DMC decision-making. Specific cases illustrating how DMCs struggle with these issues will be presented.