Overview

Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation is an international leader in improving child healthcare dating back to its start in 1883. Cincinnati Children's is a pediatric academic medical center (a nonprofit hospital and research center) pioneering breakthrough treatments, providing outstanding family-centered patient care and training health care professionals for the future. It has 673 registered inpatient beds including 102 inpatient behavioral health beds and 30 residential behavioral health beds serving southwestern Ohio, southeastern Indiana and northern Kentucky. It has more than 1,304,000 patient encounters, annually.

Cincinnati Children's is accredited to conduct clinical research by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and has been conducting pediatric research since 1931. It is the third highest recipient of NIH research grant funding among comprehensive pediatric centers. Annually, it has more than 2,000 investigator-initiated, industry-sponsored and federally sponsored IRB-active protocols including pediatric phase 1 to 4 and select adult phase 1 to 4 clinical studies.

Research Experience

Cincinnati Children's Research Foundation is dedicated to advancing basic, translational, clinical and outcomes-based research. Our researchers investigate a wide variety of childhood and adult illnesses and offer patients access to leading-edge treatments. The Research Foundation investigators have made major contributions to the advancement of pediatric medicine since it opened in 1931. Achievements by Cincinnati Children's researchers include such breakthrough discoveries as the Sabin oral vaccine, the first practical heart-lung machine that made open-heart surgery possible, and the discovery of the key ingredients of the surfactant preparation used throughout the world to save the lives of thousands of premature infants each year. More recently, Cincinnati Children's researchers were responsible for the discovery and testing of a vaccine (Rotarix) that prevents rotavirus infection, which kills half a million children throughout the world each year.

Facility Description

Cincinnati Children’s is the largest pediatric research center (per square foot) in the U.S. We provide more than 1.4 million square feet of research laboratory space to investigators working to improve child health. Included in that 1.4 million square feet is our new Clinical Sciences Pavilion. The pavilion added 445,000 square feet of space for expanded laboratories, an imaging center and supporting infrastructure. The expansion has helped to attract more of the world’s top pediatric scientists to pursue clinical trials, translational research, outcomes, improvement studies and more.

Our facilities include:

• Extensive clinical and academic research facilities;
•  Comprehensive on-site laboratories (central laboratory and multiple specialty laboratories);
• On-site investigational pharmacy;
• Monitor rooms;
• Pediatric- and adult-friendly participant exam/treatment rooms and waiting areas; and
• Convenient parking.

The medical center is located approximately three miles from downtown Cincinnati and about sixteen miles (25 minutes) from the Greater Cincinnati/Northern Kentucky International Airport. Cincinnati Children’s is in close proximity to comfortable hotel accommodations within a five-block area and is a short distance from downtown Cincinnati hotels.

Investigator Experience and Staff Expertise

We have more than 1,100 experienced Cincinnati Children’s/University of Cincinnati College of Medicine investigators and more than 500 institutionwide GCP-trained study coordinators to conduct sponsor-designed clinical studies in the following areas:

• All major medical and surgical subspecialties;
• Expert faculty and staff for protocol/product consultation;
• Research pharmacists experienced with investigational drugs;
• Study coordinators certified by the Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Associates (SoCRA); and
• CITI-trained study staff.

The researchers at Cincinnati Children’s specialize in more than 100 therapeutic areas. We also have more than 100 centers of major clinical studies, which are affiliated with other treatment and research centers nationally and internationally.

Patient Demographics

Cincinnati Children’s recruits pediatric and adult research participants primarily from the Greater Cincinnati area, including eight counties. Cincinnati Children’s patient racial profile includes:

Cincinnati Children’s cares for patients from all 50 states and 68 countries around the world with more than 1,304,000 patient encounters every year.

Other Information

Clinical Trial Support Services for Sponsors and CROs

Cincinnati Children stands ready to support research efforts by offering a wide array of research support services, shared facilities, expert consultation, research personnel and research tools for sponsors and CROs to conduct or facilitate clinical research.

An example of one support service offered by Cincinnati Children’s is the Office for Clinical and Translational Research (OCTR). The mission of the OCTR is to support and advance high-quality human subject research in accordance with the institutional mission surrounding research and education. Some support services provided by the OCTR include:

• Identification and development of research opportunities;
• Investigator identification and qualification coordination;
• Protocol development;
• Study feasibility;
• Contracts and budgets (for all funding sources);
• Translational regulatory affairs;
• Project management (single- and multicenter studies);
• Clinical operations and research study management;
• Participant recruitment and retention;
• Integration/collaboration with institutional research partners, including the Center for Technology Commercialization, Biobank, Division of Clinical Pharmacology, Data Management Center, Data Coordinating Center.

The OCTR helps sponsors and CROs place and coordinate and/or facilitate select pediatric or adult clinical studies conducted at inpatient and outpatient Cincinnati Children's facilities. The OCTR understands the needs of sponsors and CROs and is committed to conducting clinical studies with heightened attention to time constraints and budgets. The OCTR has access to all of Cincinnati Children's therapeutic divisions and collaborates with other Cincinnati Children's research centers of expertise to meet individual study requirements. Some of those centers of expertise include the Schubert Research Clinic and the Gamble Program for Clinical Studies.

If you are seeking test sites for a future study and would like further information, we encourage you to contact or visit us in Cincinnati. Our experienced, personable and caring staff are ready to assist you in the coordination of your studies. We appreciate your considering the Office for Clinical and Translational Research at Cincinnati Children’s and look forward to working with you in the future.