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 70 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 studies Phase I-IV) conforming to all regulatory requirements in an efficient and fiscally sound manner. Cincinnati Children’s conducts more than 1,000 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 2006 include:

• $203 allocated to biomedical research
• $123.4 million awarded in research grants and contracts
• $92.1 million in NIH research grant funding received, making Cincinnati Children’s the second highest recipient of such funding among comprehensive pediatric centers
• $8 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 Clinical Trials Office

The Clinical Trials Office (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 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. Annually, Cincinnati Children’s has more than 1000 investigator-initiated, industry- and federally-sponsored active IRB protocols in many of the major sub-specialty areas.

The CTO has access to all 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 Gamble Program for Clinical Studies, the General Clinical Research Center (GCRC), the Pediatric Pharmacology Research Unit (PPRU) and the Translational Research Trials Office (TRTO).

PPRU

• Cincinnati Children’s has one of 13 PPRUs established by the National Institute of Child Health and Human Development (NICHD) in response to the need to develop appropriate drug therapy for pediatric patients. The 13 PPRUs form a network of research centers across the United States designed to do both pharmaceutical and federally sponsored pediatric pharmacology studies. The mission of the PPRU network is to facilitate and promote pediatric labeling of new drugs or drugs already on the market. The network strives to foster cooperative and complementary research efforts among academia, industry and health professionals. The network sites care for 177,000 pediatric inpatients a year and more than 2 million outpatient pediatric contacts annually. Industry sponsors and investigators may submit protocols to Cincinnati Children’s PPRU for consideration to be conducted by all 13 PPRU network sites.

GCRC

• 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.

CCCR

• 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 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 20 exam rooms and an extended-stay adult unit with 36 beds.

• 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 disease (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.

• The TRTO assists researchers with a wide variety of needs related to investigator-initiated 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. TRTO staff oversees clinical data collection, tracking and reporting to local and federal agencies. In addition, the TRTO assists 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. 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 outpatient treatment satellites, all of which provide pediatric sub-specialty care.

CTO’s Clinical Research Study Credentials

Clinical Research Staff

• Experienced investigators to conduct sponsor designed clinical studies
• More than 500 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 200 experienced 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 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
• Study report preparation and submission

Participant Identification and Recruitment

• Full-time, experienced participant recruiters working with a full-complement of Cincinnati Children’s marketing and public relations staff
• Access to large, diverse pediatric and adult populations throughout the region, including Southwestern Ohio, Southeastern Indiana and Northern Kentucky
• Volunteer and past study participant database

Research Facilities - 1,000,000 square feet

• Extensive clinical and academic research facilities
• Comprehensive on-site laboratories (www.cincinnatichildrens.org/labs)
  • Central Laboratory
  • Laboratory of Applied Pharmacokinetics and Therapeutic Drug Management
  • Laboratory for Specialized Clinical Studies
  • Mass Spectrometry Laboratory
• On-site investigational pharmacies
• Monitor rooms, pediatric- and adult-friendly subject 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
• Report and manuscript writing submission and publication

The CTO is in the CCCR located on the Oak Campus of Cincinnati Children's Hospital Medical Center. Cincinnati Children’s, a 475-bed inpatient and outpatient facility, is one of the largest pediatric treatment facilities in the country. 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, a Delta Airlines hub. 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.

More than 100 therapeutic areas including:

Adolescent medicine Allergy and Clinical Immunology Anesthesia Biostatistics Cardiology Clinical Pharmacology Critical Care Medicine Dermatology Developmental Biology Developmental Disorders Drug and Poison Information Emergency Medicine Endocrinology Gastroenterology and Nutrition General and Community Pediatrics Gynecology Hematology-Oncology Human Genetics Infectious Diseases Informatics Mass Spectrometry Laboratory Molecular Cardiovascular Biology Neonatology Nephrology Neurology

Pathology Physical Medicine & Rehabilitation Psychiatry Psychology Pulmonary Biology Pulmonary Medicine Radiology and Imaging Research Center Rheumatology Technology Transfer Transplant Medicine Surgery Cardiothoracic Surgery Neurosurgery Ophthalmology Orthopedics Otolaryngology Plastic Surgery Urology

Clinical Trials Office, Division of Clinical Pharmacology

Michael Spigarelli, MD, PhD, medical director of the Clinical Trials Office
Phone: (513) 636-3232
E-mail: michael.spigarelli@cchmc.org

Philip D. Walson, MD, director of the Division of Clinical Pharmacology
Phone: (513) 636-5311
E-mail: p.walson@cchmc.org

Melinda Muenich, RN, MBA, business director
Phone: (513) 636-7130
E-mail: melinda.muenich@cchmc.org

Jackie Hullfish, BS, regulatory affairs coordinator
Phone: (513) 636-5872
E-mail: jackie.hullfish@cchmc.org

Mark Schuller, MA, marketing and recruiting manager
Phone: (513) 636-0314
E-mail: mark.schuller@cchmc.org

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

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

Pediatric Pharmacology Research Unit

Alexander A. Vinks, PharmD, PhD, director of the Pediatric Pharmacology Research Unit and Laboratory of Applied Pharmacokinetics and Therapeutic Drug Management
Phone: (513) 636-0159
E-mail: sander.vinks@cchmc.org

Denise Maseck, RN, BSN, Research Nurse Manager, Pediatric Pharmacology Research Unit
Phone: (513) 636-0157
E-mail: denise.masek@cchmc.org

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 one of every four families in Southwestern Ohio, Southeastern Indiana and Northern Kentucky. Cincinnati Children’s patient racial profile includes 18% African-American, .5% Asian, 68% Caucasian, .9% Hispanic and 12% other. Cincinnati Children’s cares for patients from most of the 50 states and countries around the world with nearly 900,000 patient encounters every year.

Admissions (FY 2007)

Admissions	16,645
Short-stay visits	10,159
Emergency Department visits	93,416
Beds in service	475
Patient encounters	917,204

Outpatient Visits (FY 2007)

Including outpatient surgery and urgent care

783,043

Surgical Procedures (FY 2007)

Inpatient	5,892
Outpatient (includes satellites)	23,069

Transplants (FY 2007)

Stem Cell	72
Heart	4
Liver	21
Kidney	18
Small Bowel	0

Annually, Cincinnati Children's has more than 1,000 investigator-initiated, industry- and federally-sponsored active IRB protocols in many of the more than 100 therapeutic areas. For study highlights, please go to http://www.cincinnatichildrens.org.

If you are investigating a site to conduct future studies or would like further information, we encourage you to contact or visit us in Cincinnati. Our experienced, personable and caring staff is ready to assist you in the coordination of your studies. We appreciate your considering Cincinnati Children’s Clinical Trials Office and look forward to working with you in the future.

CenterWatch is listing the following trials that are actively recruiting patients at this center.

• (ANBL0621) A Phase II Study of ABT-751 in Children with Relapsed or Refractory Neuroblastoma
• (ANHL06P1) A Phase I/II Pilot Study of Ifosfamide, Carboplatin, Etoposide, and Monoclonal Antibody SGN-30 in Pediatric Patients with CD30-Positive Recurrent Anaplastic Large Cell Lymphoma
• (OSU 0479) Flavopiridol in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Chronic Myelogenous Leukemia
• ¹³¹I-Metaiodobenzylguanidine (MIBG) with Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
• A Feasibility Pilot and Phase 2 Study of Chemoimmunotherapy with Epratuzumab for Children with Relapsed CD22-Positive Acute Lymphoblastic Leukemia
• A Phase 1 Study of SAHA in Pediatric Patients with Recurrent or Refractory Solid Tumors (Including Lymphomas) and Leukemia Followed by a Phase I Study of SAHA in Combination with 13 Cis-Retinoic Acid for Patients with Selected Recurrent/Refractory Solid Tumors
• A Phase I Study of CEP-701 in Patients with Refractory Neuroblastoma
• A Phase I Study of Vinblastine in Combination with Carboplatin for Children with Newly Diagnosed and Recurrent Low Grade Gliomas
• A Phase I Study Of Zoledronic Acid (Zometa) with Cyclophosphamide in Children with Recurrent or Refractory Neuroblastoma and Cortical Bone Involvement
• A Phase II Study of Sulindac and Tamoxifen in Patients with Desmoid Tumors that are Recurrent or Not Amenable to Standard Therapy
• A Phase II Study of Sulindac and Tamoxifen in Patients with Desmoid Tumors that are Recurrent or Not Amenable to Standard Therapy
• A Phase II Study of the Combination of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults with CD20 Positive Post-Transplant Lymphoproliferative Disease (PTLD) following Solid Organ Transplantation (SOT)
• A Phase II Study to Assess the Ability of Neoadjuvant Chemotherapy +/- Second Look Surgery to Eliminate All Measurable Disease Prior to Radiotherapy for Non-Germinomatous Germ Cell Tumor (NGGCT)
• A Phase Study of Temozolomide, Oral Irinotecan, and Vincristine for Children with Refractory Solid Tumors
• A Phase Study of Temozolomide, Oral Irinotecan, and Vincristine for Children with Refractory Solid Tumors
• A Pilot Study of Temozolomide and 06Benzylguanine for Treatment of Newly Diagnosed High Grade Glioma, Using Autologous Peripheral Blood Stem Cells Genetically Modified for Chemoprotection
• A Pilot Trial of Oxandrolone for the Treatment of Bone Marrow Aplasia in Fanconi Anemia
• A Research Study to Test the Safety of Reinfusing Autologous Bone Marrow, Cord Blood or Peripheral Blood Cells in Patients With Fanconi Anemia
• ADVL0612: A Phase I Study of Sunitinib (SU11248), an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Children with Refractory Solid Tumors
• Clinical Research Study for Children with Spastic Diplegia
• Collection of Hematopoietic Cells from Patients with Fanconi Anemia (FA) for Future Autologous Reinfusion and Research
• Comprehensive Sickle Cell Centers Collaborative Data Projects
• Dipyridamole/Magnesium to Improve Sickle Cell Hydration
• Dipyridamole/Magnesium to Improve Sickle Cell Hydration
• Early-Onset Bipolar Medication Study
• Effectiveness of Hydroxyurea and Magnesium Pidolate Alone and in Combination in Hemoglobin SC Disease: A Phase II Trial
• Epidemiology of Priapism
• Etanercept (Enbrel) in Children with Fanconi Anemia and Early Bone Marrow Failure, A Pilot Study
• Gene Transfer for Patients with Fanconi Anemia, Genotype A: A Pilot Study
• Herpes Vaccine Study for Women
• High Risk B- Precursor Acute Lymphoblastic Leukemia Study
• Ovary Protection Medication Study for Childhood Onset Lupus (ages 21 and under).
• Pediatric ADHD Study
• Pediatric Scoliosis Research Study
• Perinatal Neuroblastoma: Expectant Observation (Children's Oncology Group Pilot Study)
• Phase I Study of Fenretinide (4-HPR, NSC 374551) Lym-X-Sorb™ (LXS) Oral Powder In Patients with Recurrent or Resistant Neuroblastoma IND# 68,254
• Phase I Study of the RAF Kinase and Receptor Tyrosine Kinase Inhibitor Sorafenib in Children with Refractory Solid Tumors or Refractory Leukemias
• Rare Benign Vascular Tumor Registry
• Role of Placenta Growth Factor in Sickle Acute Chest Syndrome
• Self-Test Study for Females 14 to 21 -
  Do you experience vaginal itching or burning?
• Sickle Cell Adult Neurological Dysfunction (SCAN) Study
• Silent Infarct Transfusion Trial (SITT)
• Study for Teens Having Weight-Loss (bariatric) Surgery

For more information, please contact:

Mark Schuller
Marketing and Recruiting Manager
Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation
Clinical Trials Office
3333 Burnet Avenue
MLC 7004
Cincinnati, OH 45229-0161 USA
Phone: 513-636-0314
Fax: 513-636-0168
E-mail:

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.

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Last updated on May 9, 2008

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