Who We Are
The Clinical Trials Office (CTO) functions within Cincinnati Children's Research Foundation. The CTO was established as a consultative research department to help coordinate or facilitate all studies conducted by the Cincinnati Children's faculty and staff. The CTO is dedicated to providing research support services of the highest scientific quality complying efficiently with all regulatory requirements in a fiscally responsible way. It works cooperatively with many Cincinnati Children's centers of expertise to conduct studies by collaborating with and using the facilities and personnel from these divisions at Cincinnati Children's. These centers include:
The PPRU is one of 13 PPRUs established by the National Institute of Child Health and Human Development (NICHD) in response to the need for appropriate drug therapy for pediatric patients. The 13 PPRUs form a network of research centers for federally sponsored pediatric pharmacology studies across the United States. The network contains 177,000 pediatric inpatients a year and more than 2 million outpatient pediatric contacts annually. The mission of the PPRU network is to facilitate and promote pediatric labeling of new drugs or drugs already on the market. In this process, the network strives to foster cooperative and complementary research efforts among academia, industry and health professionals.
The Laboratory of Applied Pharmacokinetics and Therapeutic Drug Management provides a center for expertise in drug bioavailability, metabolism, pharmacokinetics, pharmacodynamics and clinical trials methodology. It explores new pediatric therapeutic modalities, including: molecular approaches to the treatment of diseases, application of new technology to pharmacodynamic studies and novel drug delivery systems, pediatric formulations and validation of surrogate markers. Other research interests include the development characteristics and genetic polymorphisms of drug metabolizing enzymes, as well as population pharmacokinetic modeling and simulation technology.
The GCRC is a 12-bed inpatient unit and ambulatory care facility. It is devoted to conducting high-quality, patient-oriented research studies and providing treatment of complex childhood and adult diseases. The 11,000 square foot facility provides all of the modern clinical investigation resources including biochemistry, electron microscopy, molecular biology and genetics, and mass spectrometry. Multidisciplinary groups of pediatric, surgical, obstetrical, and internal medicine sub-specialists draw on these resources to conduct research studies. The GCRC is one of 78 centers throughout the United States funded by the National Institutes of Health to conduct clinical research. It is one of eight centers housed at a pediatric facility. Since its inception in 1963, more than 25,000 infants, children, adolescents and adults have received care in the center. The GCRC fosters the growth of medical research and good research skills of investigators.
The CCCR's mission is to provide sponsors and researchers with the scientific tools and facilities to conduct today's clinical research studies. The CCCR is a 53,500 square foot facility, operated by Cincinnati Children's Research Foundation and dedicated to the support of clinical research studies for both children and adults. While Cincinnati Children's primary focus remains in pediatric care, education, and research, the CCCR was created to support both pediatric and adult (Phase I-IV) clinical research studies. The CCCR is located on Cincinnati Children's Oak Campus, and it includes an outpatient clinic and an extended-stay unit, among an extensive list of facility amenities.
Gamble Program for Clinical Studies
The Gamble Program for Clinical Studies/Division of Infectious Diseases is one of only seven National Institutes of health, Vaccine Trial and Evaluation Units in the nation. The focus of the Gamble Program is the treatment and prevention of diseases caused by a variety of viruses, including those that cause life-threatening vomiting and diarrhea (such as rotavirus), respiratory infections (such as influenza) and sexually transmitted diseases (such as genital herpes). In the past 25 years, the Gamble Program has successfully completed more than 200 clinical studies, bringing us closer to preventing influenza, rotavirus, herpes virus infections, pertussis and aiding in our fight against agents that might be used in bioterrorism attacks. Their major accomplishment to date is the licensure of a rotavirus vaccine developed by Gamble researchers that could prevent more than 500,000 deaths every year. The ongoing efforts of the program focus on finding new approaches to treating and preventing new and old diseases in both children and adults.
Translational Research Trials Office (TRTO)
The TRTO assists researchers with a wide variety of needs related to investigator-initiated investigational new drug (IND) filings with the FDA and preclinical research. Services include assisting investigators with the design of Phase I investigator-initiated clinical studies, submission of protocol/informed consent to local and federal regulatory bodies, completion and filing of IND applications, organization of regulatory documents, protocol review and monitoring, internal and external audit assistance, biostatistical support, creation of a data safety monitoring plan, management of the data safety monitoring boards, recruitment of human subjects, obtaining proper consent/assent, and data management and analysis. TRTO staff oversee clinical data collection, tracking and reporting to local and federal agencies. In addition, the TRTO assists investigators in establishing and maintaining biological specimen repositories with the use of the proprietary specimen repository database linked to a protocol management system termed Protocol Manager (PM) and Biological Specimen Tracking System (BSTS). Both disease-specific and normal donor registries have been developed. The normal donor protocols include the collection of umbilical cord blood, peripheral blood, G-CSF mobilized peripheral blood stem cells (PBSCs) and bone marrow that are available to laboratory scientists.
In addition to its internal professional staff and research facility resources, Cincinnati Children's has links to a number of large networks including cystic fibrosis, endocrinology, gastroenterology, hematology/oncology, hepatology, neonatology, rheumatology and sickle cell. It is also linked to private practice physicians and practices in Greater Cincinnati (including the practice-based research network of more than 30 practices, Cincinnati Pediatric Research Group). Cincinnati Children's also has service connections with other regional pediatric care facilities, as well as 18 primary care facilities and ten outpatient treatment satellites, all of which provide pediatric sub-specialty care.
