Clinical Trial Resource Center

Therapeutic Areas

Cardiology/Vascular Diseases
Dental and Oral Health
Dermatology
Endocrinology
Gastroenterology
Genetic Disease
Hematology
Hepatology (Liver, Pancreatic, Gall Bladder)
Immunology
Infections and Infectious Diseases
Internal Medicine
Musculoskeletal
Nephrology
Neurology
Nutrition and Weight Loss
Oncology
Ophthalmology
Otolaryngology (Ear, Nose, Throat)
Pediatrics/Neonatology
Pharmacology/Toxicology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Sleep
Trauma (Emergency, Injury, Surgery)
Urology
Vaccines

Center Overview

Mission:
The Clinical Trials Office’s mission is to provide clinical investigators and sponsors with comprehensive support services, research tools, personnel and facilities to conduct or facilitate pediatric and adult clinical research studies.

Overview:
Thank you for your interest in the Clinical Trials Office (CTO) of Cincinnati Children’s Hospital Medical Center/Cincinnati Children’s Research Foundation (Cincinnati Children’s). Cincinnati Children’s is one of the nation’s top pediatric academic medical centers with more than 80 years of experience in patient care and research (Phase I - IV clinical studies). The faculty and staff of Cincinnati Children’s routinely conduct quality research in all the major pediatric subspecialties (as well as some select adult cancer and vaccine studies Phase I-IV) conforming to all regulatory requirements in an efficient and fiscally sound manner. Cincinnati Children’s conducts more than 2,100 industry, investigator-initiated and National Institutes of Health (NIH) sponsored clinical studies, annually. Its renowned research staff attracts millions of dollars in research funding, and private and corporate donations each year.

Cincinnati Children’s highlights from fiscal year 2012 include:

• $314 allocated to biomedical research
• $173 million awarded in research grants and contracts
• $106.6 million in NIH research grant funding received, making Cincinnati Children’s the second highest recipient of such funding among comprehensive pediatric centers
• $17 million awarded in industry research grants and contracts

Cincinnati Children’s is an international leader in improving child healthcare dating back to its start in 1883. Cincinnati Children’s Research Foundation, owned and operated by Cincinnati Children’s, investigates a wide variety of childhood and adult illnesses and offers 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.

Meeting Your Clinical Studies Needs Through the CTO

Clinical Study Support Services
The CTO of Cincinnati Children’s offers a comprehensive research support program to assist you with your clinical studies. The CTO assists sponsors and investigators to place, coordinate and/or facilitate pediatric or adult clinical studies conducted at inpatient and outpatient Cincinnati Children’s facilities. The CTO understands sponsors’ needs and is committed to conducting clinical studies with heightened attention to time constraints and budgets.

The CTO has access to all of Cincinnati Children’s therapeutic divisions as well as collaborating with other Cincinnati Children’s research centers of expertise to meet your study needs. Some of those centers include the Cincinnati Center for Clinical Research (CCCR), the Clinical Translational Research Center (CTRC), the Gamble Program for Clinical Studies and Translational Research Support Services.

CCCR
The CCCR provides 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 part of a $5 million refurbishing and remodeling project included on Cincinnati Children’s Oak Campus, which is predominantly devoted to research. The research facility includes an outpatient clinic with 18 exam rooms and an extended-stay adult unit with 36 beds.

CTRC
The Clinical Translational Research Center (CTRC), formerly the General Clinical Research Center (GCRC), is based at Cincinnati Children’s main facility and provides resources to perform high-quality, patient-oriented research internally and at various health care venues in Cincinnati. The CTRC is one of 61 Clinical and Translational Science Award (CTSA) Consortium member institutions throughout the United States, funded by the National Institutes of Health (NIH) to conduct clinical research. The CTRC is dedicated to supporting pediatric and adult research. It comprises a six-room outpatient clinic, inpatient admitting capabilities for research only and mixed clinical and research admissions (including 24 hour short stays), and a sleep research lab including four beds for sleep research. Researchers can also make use of “scatter beds” for research throughout Cincinnati Children’s, University of Cincinnati Medical Center and other community locations. CTRC research nurses can perform study specific skills and procedures while the study participants are admitted or being seen clinically. The VA Medical Center CTRC satellite facility is a unit for adult subjects including two inpatient rooms with cardiac monitoring, five outpatient rooms and three procedure rooms.

Gamble Program for Clinical Studies
The Gamble Program for Clinical Studies/Division of Infectious Diseases is one of only eight National Institutes of Health funded, Vaccine Trial and Evaluation Units (VTEUs) in the nation. The focus of the Gamble Program is to perform clinical trials aimed at the treatment and prevention of infectious diseases caused by a variety of pathogens, including those that cause severe vomiting and diarrhea (such as norovirus, shigella and cholera), respiratory infections (such as influenza) sexually transmitted disease (such as genital herpes)and agents of bioterrorism (such as anthrax) . During the past 25 years, the Gamble Program has successfully completed more than 200 clinical studies, in subjects ranging in age from infants to the elderly. These trials are supported by a state of the art laboratory – the Laboratory for Specialized Clinical Studies. Their major accomplishment to date is the licensure of a rotavirus vaccine developed by Gamble researchers that is used around the world. The ongoing efforts of the program focus on finding new approaches to treating and preventing new and old infectious diseases in both children and adults.

Translational Research Support Services
The Clinical Trials Office can assist researchers with a wide variety of needs related to Investigational New Drug (IND) filings with 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 Investigational New Drug (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. Our staff oversees clinical data collection, tracking and reporting to local and federal agencies. In addition, we assist investigators in establishing and maintaining biological sediment 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. Cincinnati Children's also has service connections with other regional pediatric care facilities, as well as 15 primary care facilities and outpatient treatment satellites, all of which provide pediatric sub-specialty care.

Clinical Research Experience

CTO’s Clinical Research Study Credentials

Clinical Research Staff

• Experienced investigators to conduct sponsor designed clinical studies
• More than 1,100 Cincinnati Children’s/University of Cincinnati College of Medicine investigators
• All major medical and surgical subspecialties
• Expert faculty and staff for protocol/product consultation
• Research pharmacists experienced with investigational drugs
• More than 300 institution-wide GCP trained study coordinators
• Certified study coordinators: Association of Clinical Research Professionals (ACRP) and Society of Clinical Research Associates (SoCRA)

Study Planning

• Knowledgeable in study design to meet the needs of investigators and sponsors

Contract/Budget

• Experience in creating and negotiating contracts and budgets

Quality Protocol Conduct

• Compliance with Food and Drug Administration (FDA), International Conference on Harmonization (ICH) and Code of Federal Regulations (CFR) requirements for Good Clinical Practice (GCP) study conduct
• On-site local IRB with weekly scheduled meetings
• Experienced regulatory affairs coordinator to maintain regulatory documents both during and after study completion
• Standard Operating Procedures (SOPs) consistent with regulatory requirements
• Investigator and coordinator training in GCP and research study management with CEU and CME credits
• In-house compliance quality review (audits) of ongoing studies
• Centralized scheduling of principal investigator meetings, site assessment and initiation meetings and study monitoring visits

Participant Identification and Recruitment

• Full-time, experienced study participant recruiters to customize strategic recruitment plans (using a variety of tactics - marketing, advertising, public relations and social media) depending on the study’s needs
• Access to large, diverse pediatric and adult populations throughout the region, including Southwestern Ohio, Southeastern Indiana and Northern Kentucky
• Divisional, departmental and volunteer (healthy) study participant databases

Research Facilities - 1,000,000 square feet

• Extensive clinical and academic research facilities
• Comprehensive on-site laboratories ( www.cincinnatichildrens.org/labs)
  • Central Laboratory
  • Multiple specialty laboratories
• On-site investigational pharmacies
• Monitor rooms, pediatric- and adult-friendly participant exam/treatment rooms and waiting areas
• Convenient parking

Data Management and Reports

• Center for Epidemiology and Biostatistics providing statistical and data analysis support
• Ethically-produced, high-quality, clinical and research data

Facility Description

Cincinnati Children’s Hospital Medical Center/Cincinnati Children’s Research Foundation is a not-for-profit hospital and research center pioneering breakthrough treatments, providing outstanding family-centered patient care and training health care professionals for the future. 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 second highest recipient of NIH research grant funding among comprehensive pediatric centers.

Cincinnati Children’s is a full-service, pediatric academic medical center with 587 registered inpatient beds (including 85 inpatient psychiatry beds and 36 residential psychiatry beds) serving Southwestern Ohio, Southeastern Indiana and Northern Kentucky. It has more than 1,144,858 patient encounters, annually.

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.

Investigator Experience

More than 100 therapeutic areas including:

Staff Expertise

Office for Clinical and Translational Research

John Clancy, MD, medical director
513-636-3232
john.clancy@cchmc.org

Leslie Sullivan-Stacey, JD, director
513-803-1846
Leslie.Sullivan-Stacey@cchmc.org

Elizabeth Moriarity, BSN, regulatory affairs specialist
513-803-5025
elizabeth.moriarity@cchmc.org

Mark Schuller, MA, marketing and recruiting manager
513-636-0314
mark.schuller@cchmc.org

Jane Howie, BS, marketing and recruiting coordinator
513-636-0158
jane.howie@cchmc.org

Sara Helbig, BA, marketing and recruiting coordinator
513-636-4104
sara.helbig@cchmc.org

Pamela Jordan, BS, contracts and budgets specialist
(513) 636-3203
pamela.jordan@cchmc.org

Steve Hope, contracts and budgets specialist
(513) 803-0772
stephen.hope@cchmc.org

Patient Demographics

Cincinnati Children’s recruits pediatric and adult participants 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 19.1 percent African-American, 0.1 percent American Indian/Alaska Native, 1.2 percent Asian/Pacific, 63.6 percent Caucasian, 0.1 percent Native Hawaiian/other Pacific Islander and 15.9 percent other. Cincinnati Children’s cares for patients from most of the 50 states and 47 countries around the world with more than 1,144,858 patient encounters every year.

Admissions (FY 2012)

Outpatient Visits (FY 2012)