Coffey to present CPH Distinguished Faculty Lecture Aug. 29

UI College of Public Health 2017 Distinguished Faculty Lecture

Chris CoffeyWe Built This Network: How NeuroNEXT Increases Innovative Design in Academic Trials


Chris Coffey, PhD
Professor of Biostatistics and Director of the Clinical Trials Statistical and Data Management Center
College of Public Health, The University of Iowa

Wednesday, August 29
12:30 p.m.
Callaghan Auditorium
N110 College of Public Health Building

A reception will follow in the CPHB atrium.

The traditional approach to clinical trials tends to be large, costly, and time-consuming. Correspondingly, there is a need for more efficient clinical trial design, which has recently led to substantial interest in the use of innovative trial designs.

For example, adaptive designs allow reviewing accumulating information during an ongoing clinical trial to possibly modify trial characteristics. Although there are a large number of proposed adaptations, regulatory groups support the notion that all changes should be based on pre-specified decision rules. This often requires research groups to conduct properly designed simulation studies in order to confirm that the proposed adaptations preserve the integrity and validity of the study.

To address this issue, there has been an industry movement towards creating in-house teams primarily responsible for planning and conducting such simulations. Greater barriers exist for implementing this same type of infrastructure within the academic clinical trials environment. For example, the simulations would need to be conducted before the design is finalized – which must occur well before a typical grant submission to support funding for a proposed trial. For researchers who are completely grant-funded, few mechanisms exist to support these complex simulation studies.

As a result, there is a growing divide between the practicality and feasibility of conducting adaptive designs in industry compared to academia. Since acceptance of adaptive designs in general will depend on increasing their use across all types of clinical trials, infrastructure-building efforts are needed within the academic clinical trials environment in order to help further advance the use of adaptive designs.

One recent example of such an effort is the creation of the NINDS-funded Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). The Network infrastructure provides support for a group of senior statisticians with a great deal of experience in protocol and grant development for clinical trials. This infrastructure dramatically increases the feasibility for using more novel trial designs – including adaptive designs.

In this presentation, Dr. Coffey will provide a summary of the NeuroNEXT experience to date and illustrate how initiatives like NeuroNEXT greatly increase the practicality of using adaptive designs in an academic trials setting.


Individuals with disabilities are encouraged to attend all University of Iowa–sponsored events. If you are a person with a disability who requires a reasonable accommodation in order to participate in this program, please contact the College of Public Health in advance at 319-384-1500.

Video: CTSDMC helps research move forward

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.

Biostat’s CHAMP study cited as one of “Best Advances of 2016”

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.

Pediatric migraine study named a Top Story of 2016

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.

Read more in Iowa Now