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 - 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- and federally-sponsored IRB active protocols including pediatric phase I-IV, and select adult phase I-IV clinical studies.

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. Historically, 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.

For Sponsors and CROs

Clinical Trial Support Services

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

An example of one support service offerred by Cincinnati Children’s Research Foundation 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 multi-center 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)

For sponsors and CROs, the OCTR assists to place, 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 as well as 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.

Learn more about the clinical trial support services offered by the OCTR at Cincinnati Children’s.

Facility

Research Facilities and Location

Cincinnati Children’s is the largest pediatric research center (per square footage) in the United States of America. 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 and improvement studies and more.

Our facilies include:

• Extensive clinical and academic research facilities
• Comprehensive on-site laboratories
  • Central Laboratory
  • Multiple speciality laboratories
• On-site investigational pharmacy
• Monitor rooms
• Pediatric- and adult-friendly participant exam/treatment rooms and waiting areas
• 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, as well as a short distance from downtown Cincinnati hotels.

Learn more about our facilities

Investigator

Investigator and Clinical Research Staff Experience

We have more than 1,100 experienced Cincinnati Children’s/University of Cincinnati College of Medicine investigators and more than 500 institution-wide GCP trained study coordinators to conduct sponsor-designed clinical studies.

• All major medical and surgical subspecialties
• Expert faculty and staff for protocol/product consultation
• Research pharmacists experienced with investigational drugs
• Certified study coordinators: Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Associates (SoCRA)
• CITI trained study staff

Therapeutic Areas and Centers of Expertise

The researchers at Cincinnati Children’s specialize in more than100 therapeutic areas. We also have more than 100 centers of major clinical studies expertise, which are also affiliated with other treatment and research centers nationally and internationally (visit Specialties and Centers of Expertise to see a full listing).

Patients

Patient Demographics and Statistical Highlights

Cincinnati Children’s recruits pediatric and adult research participants primarily from the Greater Cincinnati area including eight counties. As Greater Cincinnati’s only pediatric hospital, Cincinnati Children’s serves families in Southwestern Ohio, Southeastern Indiana and Northern Kentucky. Cincinnati Children’s patient racial profile includes 19.2 percent African-American, 0.1 percent American Indian/Alaska Native, 1.4 percent Asian/Pacific, 63.5 percent Caucasian, 0.1 percent Native Hawaiian/other Pacific Islander and 15.8 percent other. 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.

For further information about patient demographics as well as statistical highlights from FY2016, visit our Facts and Figures .

Other

For more information about Cincinnati Children’s and how we can support your clinical trial, please visit:
www.cincinnatichildrens.org
www.cincinnatichildrens.org/octr
www.cincinnatchildrens.org/clinical-studies
https://www.cincinnatichildrens.org/research/cincinnati/support

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.