TABLE 1

Recommendations for Practice

• DMCs should be established for all pediatric trials: (1) addressing major morbidity or mortality end points; (2) with preplanned interim analyses and the possibility of early stopping; (3) in populations with a high risk of severe outcomes; and (4) investigating new interventions with few safety data available
• Criteria for conflicts of interest should be established by the trial sponsor. Sponsors should avoid including persons with major conflicts of interest on the DMC to maximize independent decision-making
• A charter describing DMC operational procedures, including assessment of conflicts of interest, should be established and agreed on by the trial sponsor, steering group (if any), and the DMC before opening the trial to accrual
• The final report of a trial should describe the key aspects of DMC activities, including conduct of interim analyses, whether they were planned or ad hoc, their timing, what triggered them, and which statistical methods were used; it should also state whether the trial stopped early, for what reason, and whether the decision was based on a recommendation from the DMC