The University of Iowa’s Clinical Trials Statistical and Data Management Center contributed to a study that was named one of the New England Journal of Medicine’s Journal Watch Pediatrics and Adolescent Medicine Top Stories of 2016.
The study found that two pills frequently prescribed to children to prevent migraines were no more effective than a placebo, even though the two drugs—amitriptyline and topiramate—prevent migraines in adults.
The evidence was so overwhelming researchers stopped the trial early. The results were published in the The New England Journal of Medicine.
The study was conducted by Cincinnati Children’s Hospital Medical Center and the University of Iowa College of Public Health’s Clinical Trials Statistical and Data Management Center. Dr. Christopher Coffey, director of the CTSDMC and professor of biostatistics in the University of Iowa’s College of Public Health, says the data management center served as the data coordinating center (DCC) for the study. Coffey says UI researchers entered and cleaned the data using a web-based data entry system developed and maintained at the DCC.
The UI researchers also had primary responsibility for all statistical aspects of the study and analyzing primary study data. They were responsible for all data management, safety monitoring, and clinical site monitoring activities for the study.