Every day at Cincinnati Children’s, hundreds of children visit our campuses to receive investigational medications, emerging therapies, new diagnostic tests, behavioral interventions, and other innovative forms of care.

At any given time, we have more than 50 clinical trials actively enrolling participants to learn more about childhood development, disease risk and more.

Helping our research faculty conduct clinical research takes a team of more than 30 people working in the Office for Clinical and Translational Research (OCTR). The office provides assistance for all types of studies with investigators determining the level of support they need.

Working with industry

The OCTR offers specialized experience in supporting complex industry clinical trials, including participant and sponsor interactions, data collection, and regulatory activities.

For example, Cincinnati Children’s has been a strategic partner in Pfizer’s Investigator Networks, Site Partnerships, and Infrastructure for Research Excellence (INSPIRE) network for several years. We also collaborate with the Institute for Advanced Clinical Trials for Children (I-ACT), which receives FDA support for their mission to ensure quality pediatric clinical trials.

Ongoing support for trials

“The OCTR team and the excellence of pediatric investigators on our faculty attracted I-ACT leadership to choose Cincinnati Children’s as a network site,” says our I-ACT site champion Scott Powers, PhD. “A key goal of I-ACT is to streamline and increase the efficiency of clinical trial start-up, so the data that the OCTR team generates about this process will be critical to our improvement science mission.”

Once a clinical trial begins, the OCTR’s clinical research coordinators and research nurses work closely with the staff in the Schubert Research Clinic (SRC), which was launched as part of our recently built Clinical Sciences Pavilion. The SRC consolidates a number of clinical research activities, including 28 exam rooms, an imaging center and a metabolic kitchen.

“The OCTR staff brings a high level of clinical research implementation and understanding of SRC processes for all the studies that they conduct here. This allows for successful study visits and creates a cohesive study team,” says Becca Harper, Director of the Schubert Research Clinic.

One-stop for families

Neurology expert Steve Wu, MD, Director of the Dystonia Clinic, recently worked with the OCTR on an investigational drug study to evaluate a potential treatment for ataxia telangiectasia.

“The OCTR’s support was crucial, especially for study coordination and regulatory services,” Wu says. “This was a complex study. In addition to the OCTR and SRC, we relied on support from multiple other divisions.”

During a day-long visit, patients could be seen by neurologists, behavioral scientists, RNs, and cardio-perfusion staff. Microbiologists, the Investigational Pharmacy and other lab personnel also were involved.

And yet, the patient and family stay in one place during their visits.

“The OCTR and SRC helped bring everything to them,” Wu says.