Guides to Support the Regulatory Journey

The OCTR Provides a One-Stop Shop to Assist Clinicians and Scientists with Every Stage of Clinical Research

The Office for Clinical and Translational Research (OCTR) provides a crucial support system for clinical research investigators and industry sponsors.

OCTR facilitates pediatric and adult clinical research at each step, from identifying and developing research opportunities through the final phases of clinical trials.

Cincinnati Children's is one of the few pediatric institutions in the U.S. with the infrastructure necessary to support such projects.

The 45-plus members of the OCTR's multidisciplinary team function as an in-house agency and “one-stop” clinical research support center for investigators.

The OCTR team works alongside the basic scientists and clinicians. It includes regulatory specialists with strong scientific backgrounds, and partners with experts from the federal Food and Drug Administration and the Institutional Review Board.

Typically, the OCTR assists researchers to improve existing treatments or explore new options. Sometimes, it scrutinizes in-use medications. One recent example is a study analyzing the efficacy of two drugs used to treat migraine headaches.

OCTR Director Scott Powers, PhD, Division of Behavioral Medicine and Clinical Psychology, was a key recipient of research assistance this past year.

In a clinical trial that was halted early, Powers and colleagues found that the commonly prescribed drugs amitriptyline and topiramate were no more effective than a placebo in reducing the severity and frequency of migraines. Both drugs have side effects.

“The OCTR was tremendous,” says Powers, who also is co-director of the Headache Center at Cincinnati Children’s.

“I used every piece of that office," he says, "from protocol to IND (investigational new drug application) to research nurses to a medical writer.”