Clinical trials for neurological diseases are long and arduous. See how the Clinical Trials and Statistical Data Management Center at the University of Iowa is helping to simplify the process by coordinating data for NeuroNEXT network.
The College of Public Health’s Clinical Trials Statistical and Data Management Center (CTSDMC) contributed to a 2016 children’s migraine study that was recently selected by editors at the American Academy of Neurology as one of the most important advances of the year.
The CHAMP study, co-authored by biostatistics professor and CTSDMC director Christopher Coffey, found that prescribed medications are no more effective than a placebo when used to prevent migraines in children and teens. The study was published in the New England Journal of Medicine.
Bruce Cohen, professor of pediatrics at Northeast Ohio Medical University and a member of the academy’s editorial advisory board for the weekly publication, Neurology Today, identified the CHAMP study as one of only two studies that met the criteria for “Best Advances of 2016” in the Pediatric Neurology category. The designation is intended to highlight “the most important advances, policies, and professional issues that occurred during the past 12 months,” according to the publication.
Joe Cavanaugh, professor and head of the Department of Biostatistics, said the citation was “impressive recognition of a study that will clearly have a profound impact on the treatment of pediatric migraines.”
“Yet another example of the stellar research being conducted by our colleagues in the CTSDMC!” said Cavanaugh.
Congratulations to the Clinical Trials Statistical and Data Management Center, which 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 UI College of Public Health’s Clinical Trials Statistical and Data Management Center. Christopher Coffey, director of the CTSDMC and professor of biostatistics in the UI’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.