Center Overview

The CAMC Institute Clinical Trials Center is a centralized clinical research center dedicated to research full-time, and is affiliated with West Virginia University, providing superior patient care and clinical trial performance. The Center is experienced in conducting Phase II-IV clinical trials evaluating a myriad of therapeutic areas. It gives area patients access to investigational drugs, innovative procedures, and new therapies, reducing their need to travel outside West Virginia for care. Some highlights of the Center are:

• Research staff is available 24 hours a day, seven days a week, for protocol-specific patient care.
• Complete adherence to FDA regulations
• Protocol adherence
• In full compliance with GCPs and GLPs
• Complete set of SOPs
• Our clinical investigators are board-certified and our organization is well-versed in FDA regulations and guidelines.
• Secured investigational drug service space and drug storage
• Secured storage space for case report forms and other study-related documents
• Computerized patient database
• Computerized multi-disciplinary investigator database
• CLIA- and CAP-approved laboratory (CAMC)

The CAMC Institute is a CAMC, Inc., subsidiary, which includes hospitals, primary care facilities, subspecialty practices, a university affiliation, a children's hospital, and nursing homes. We can provide virtually any patient population in a variety of settings. Because of our affiliation with Charleston Area Medical Center, we have access to over 550 physicians and surgeons.

About 80% of the Center's studies come from industry or cooperative groups, including the National Cancer Institute's network affiliates. The remaining 20% are generated by local investigators. The Center is involved in many national, multicenter studies.

The CAMC Institute Clinical Trials Center provides a focused mechanism for evaluating new drugs and drug uses, new medical devices, and quality of life aspects associated with the use of these products. These studies are conducted within our own facilities as well as at hospitals, clinics, and physicians' offices. The Institute plays an essential role in encouraging and supporting quality research in a controlled medical setting.

The CAMC Institute Clinical Trials Center is an obvious choice for today's researcher. Our current involvement includes clinical trials of drugs and devices, prevention programs, outcomes/quality improvement, and quality of life studies. We conduct both industry-sponsored and federally funded clinical trials. These projects have been implemented in a variety of therapeutic areas including cardiology, oncology, infectious diseases, endocrinology/metabolism, gynecology, surgery, and device development.

The Center also offers centralized management for clinical trials, providing a single point of contact to sponsors and contract research organizations. In addition, a centralized institutional research and grants review office is available for prompt human subject and contract review.

West Virginia statistics indicate that the state's rates of heart disease and stroke mortality have been higher than the national average for the past three decades, and the gap between the state and nation continues to widen. Helping CAMC, Inc., reduce these dismal statistics is central to the Clinical Trials Center's mission. Recent efforts aimed at reducing cardiovascular morbidity and mortality have attracted studies on reducing restenosis rates after angioplasty and treating patients with unstable angina and MI.

We are interested in conducting research that will benefit the people of West Virginia. The application of what we learn from research is vital to the improvement of the health, quality of service, and patient care throughout West Virginia. As a system, we at CAMC, Inc., are dedicated to providing the latest in new therapies and applications. As professionals in a growing research testing center, we make our facilities and resources available for clinical research studies.

Through research, education, intervention, and health promotion, we can change lives and improve the health of the people we serve. Services performed by the CAMC Institute Clinical Trials Center are multifaceted, improving health care opportunities for CAMC, Inc., professionals and patients. Research projects support CAMC, Inc., focus on health promotion and prevention.

On the preventive front, the CAMC Institute Clinical Trials Center was chosen as one of three sites in the nation to participate in a two-year smoking cessation trial. One hundred and eighty-four West Virginians participated in this trial.

CAMC Institute's Clinical Trials Center has established a reputation for conducting clinical trials efficiently and effectively. Our investigators are experienced with clinical trials and have a broad range of specialties. We also have experienced certified clinical research coordinators, research nurse coordinators, research assistants, and support staff. Biostatistical assistance and study analysis is available through the CAMC Institute, as well as research assistance for preparation of institutional review board and other regulatory documentation. We are also very experienced in budget preparation and study implementation.

Our patient referral base and our continually expanding computerized database assure rapid patient screening and enrollment. Our affiliations with hospitals, clinics, managed care, extended care facilities and private physicians help to provide an aggressive, cost-efficient approach to patient recruitment.

All studies are conducted by trained coordinators and investigators according to rigorous quality standards.

Research Support Services:

• Patient recruitment and follow-up
• Centralized site management for clinical trials
• Experienced and certified study coordinators
• Core research support staff
• Preparation for site qualification
• Study implementation
• Study analysis
• Research assistance for preparation of IRB and regulatory documents
• Identification of research opportunities
• Study recruitment
• Referral education
• Advertising
• Teaching/inservice of staff nurses, physicians, allied health, and patients and their families
• Data collection and management; data storage
• Study medication and study device responsibility; pharmacy liaison

Clinical Research Experience

The CHERI Clinical Trials Center has been involved with clinical research for 17 years. We conduct studies in Phases II, III, IIIb/IV in:

• Cardiology (both device and drug)
• Endocrinology/Metabolism
• Internal Medicine
• Hematology/Oncology
• Infectious Disease
• Neurology
• OB-GYN
• Pain Management
• Pediatrics
• Reproductive Medicine
• Respiratory Disease/Pulmonology
• Smoking Cessation
• Surgery

Sponsors we have worked with:

• Advanced Cardiovascular Systems, Inc.
• The Agency for Health Care Policy and Research (AHCPR)
• Alexion Pharmaceuticals
• Amgen
• Arterial Vascular Engineering, Inc.
• Boston Scientific Corporation
• Bristol-Myers Squibb Company
• Centocor
• Cordis
• Eastern Cooperative Oncology Group (National Cancer Institute)
• Eli Lilly
• Embol-X
• Genentech
• Gilead Sciences
• Glaxo Wellcome
• Guidant Corporation
• Hoechst Marion Roussel
• Hoffman-LaRoche, Inc.
• I.D.D.S. Inc.
• ImClone Systems Inc.
• Johnson and Johnson
• Medtronic AVE
• National Heart, Lung & Blood Institute (NHLBI)
• National Surgical Adjuvant Breast and Bowel Project (National Cancer Institute)
• Novartis
• Ortho-McNeill
• Parke-Davis
• Pediatric Oncology Group (National Cancer Institute)
• Pfizer
• Rhone-Poulenc Rorer
• Sanofi
• Schering-Plough Corporation
• Schneider
• Shelhigh, Inc.
• SmithKline Beecham
• Southwest Oncology Group (National Cancer Institute)
• St. Jude Medical
• Texas Biotechnology
• 3 M

CROs we have worked with:

• Advanced Biologics
• Bailer Research
• Clin Trials
• Clinical Research Partners, Inc.
• Covance
• ICON Clinical Research
• Kern McNeill International
• Paragon Biomedical
• Parexel International Corporation
• Pharmaceutical Research Associates
• The Phoenix
• PPD Pharmaco
• PPD Development
• Quintiles, Inc.
• Quintiles Pacific, Inc.
• Scirex

Facility Description

The CAMC Institute Clinical Trials Center, with its affiliation to Charleston Area Medical Center (CAMC), West Virginia's largest health care provider, and West Virginia University, is an obvious choice for today's researcher. CAMC is fully accredited by Joint Commission for the Accreditation of Health Care Organizations (JCAHO). In addition, the medical center is affiliated with many other hospitals and health care facilities throughout the state and serves southern West Virginia's population of more than 500,000. Demographically, the population is broadly distributed among all age, education, and income groups. We have the capabilities of conducting outpatient studies within the CAMC Institute Clinical Trials Center. The center is equipped with full service exam rooms and laboratory, an EKG machine, locked storage for investigational drugs and devices, refrigerator for temporary storage of drug and/or specimens, and secure storage for CRFs. In addition, we are able to conduct inpatient studies at Charleston Area Medical Center. CAMC is a 900 bed full service hospital with a dedicated Investigational Drug Pharmacist. Geographically, we are five minutes from Yeager Airport, and 2-4 hours from several major cities, including Pittsburgh, Columbus, and Cincinnati.

Investigator Experience

Ali F. AbuRahma, M.D.
Peripheral Vascular and Vascular Surgery, General Surgery

Mario R. Balmaseda, M.D.
Physical Medicine and Rehabilitation

Mark C. Bates, M.D.
Cardiovascular Disease

James P. Boland, M.D.
General Surgery, Vascular Surgery, Trauma, Thoracic and Cardiovascular Surgery

John L. Chapman, M.D.
Thoracic and Cardiovascular Surgery, Vascular Surgery

Justin D. Cohen, M.D.
Hematology/Oncology

Michael A. Covelli, M.D.
General Surgery, Surgical Oncology, Vascular Surgery

Nestor F. Dans, M.D.
Thoracic and Cardiovascular Surgery, Vascular Surgery

John A. DeLuca, M.D.
General Surgery, Vascular Surgery, Trauma

James N. Frame, M.D.
Hematolory/Oncology

John L. Goad, M.D.
Cardiovascular Disease

Gordon Green, M.D.
Pediatrics and Emergency Medicine

Edward J. Grey, M.D.
Pulmonary Disease

Stephen R. Grubb, M.D.
Endocrinology, Diabetes, and Metabolism

Omar K. Hallak, M.D.
Cardiovascular Disease

Michael B. Harman, M.D.
Radiation Oncology

Sulaiman B. Hasan, M.D.
Thoracic and Cardiovascular Surgery, Vascular Surgery

S. Greg Heywood, M.D.
Obstetrics and Gynecology

Stephen Jubelirer, M.D.
Hematology/Oncology

James W. Kessel, M.D.
General Surgery, Vascular Surgery, Trauma

Jamal H. Khan, M.D.
Thoracic and Cardiovascular Surgery, Vascular Surgery

M. Zafrullah Khan, M.D.
Thoracic and Cardiovascular Surgery, Vascular Surgery

Raheel R. Khan, M.D.
Pediatric Infectious Diseases

Jay J. Kim, M.D.
Thoracic and Cardiovascular Surgery, Vascular Surgery

Kiren J. Kresa-Reahl, M.D.
Neurology

Kee C. Lee, M.D.
Thoracic and Cardiovascular Surgery, Vascular Surgery

Stephen A. Lewis, M.D.
Cardiovascular Disease

Donald R. Lilly, M.D.
Cardiovascular Disease

B. Daniel Lucas, Pharm. D.
Cardiovascular Pharmacology/Outcomes/Pharmacoeconomics

Frank C. Lucente, M.D.
General Surgery, Vascular Surgery, Trauma

Firasat S. Malik, M.D.
Thoracic and Cardiovascular Surgery, Vascular Surgery

Eric P. Mantz, M.D.
General Surgery, Vascular Surgery

Ronald McCowan, M.D.
Cardiovascular Disease, Clinical Cardiac Electrophysiology

Kathleen Mimnagh, M.D.
Internal Medicine, Emergency Medicine

Norman Montalto, D.O.
Family Practice

Kurt M. Nelhaus, M.D.
Critical Care Medicine and Pulmonary Disease

Frederic H. Pollock, M.D.
Orthopedics

Humayun Rashid, M.D.
Thoracic and Cardiovascular Surgery, Vascular Surgery

M. Salim Ratnani, M.D.
Thoracic and Cardiovascular Surgery, Vascular Surgery

Harry L. Reahl, M.D.
Neurology

J. Gregory Rosencrance, M.D.
Internal Medicine

Ron Sarken, M.D.
Hematology/Oncology

David E. Seidler, M.D.
Emergency Medicine

Arvin B. Shah, M.D.
Hematology/Oncology

A. Christine Teague, Pharm.D.
Pharmacy/Infectious Diseases

Jashvantlal K. Thakkar, M.D.
Cardiovascular Disease

James P. Tierney, D.O.
Urology

S. Willis Trammell, M.D.
General Surgery, General Vascular Surgery

N. Andrew Vaughan, M.D.
Cardiovascular Disease

Stafford G. Warren, M.D.
Cardiovascular Disease

Todd A. Witsberger, M.D.
General Surgery, General Vascular Surgery, Trauma

Feredoun Zangeneh, M.D.
Pediatric Endocrinology

Staff Expertise

Holly Blackwood, RN, BSN
Clinical Research Coordinator
2+ years experience in clinical research

Abdul Karim Elhabyan
Clinical Research Fellow

Joy S. Hogan, LPN Ph
Clinical Research Coordinator
4 months experience in clinical research

B. Daniel Lucas, Jr. Pharm.D.
Director, Centers for Clinical Sciences Research
8 years experience in clinical research

Lisa Luikart, B.B.A.
Clinical Research Coordinator
3 years experience in clinical research

Jean Matthews, RN
Clinical Research Coordinator
4 months experience in clinical research

Sandi Mitchell
Staff Assistant
1 year experience in clinical research

Barbara Resler, RN, MSN
Clinical Research Coordinator
1 year experience in clinical research

Kristi Denison Sutphin, B.B.A.
Clinical Research Coordinator
1 year experience in clinical research

Cyndi Tignor, RN
Clinical Research Coordinator
1 year experience in clinical research

Patient Demographics

Charleston Area Medical Center (CAMC) serves Southern West Virginia's population of more than 500,000. Demographically, the population is broadly distributed among all age, educational, and income groups. According to the U.S. Census Bureau, West Virginia's population has the highest median age (37.7) in the nation, and ranks fourth in the United States in the proportion of its population that is elderly (65+). In addition, women compose a larger percentage of the population in West Virginia than in the nation as a whole (53.1%).

According to the 1998 West Virginia County Health Profiles, West Virginia ranks higher in a national comparison in the following areas:

• Cardiovascular diseases
• All cancers
• Chronic obstructive pulmonary disease (COPD)
• Unintentional injuries
• Diabetes mellitus
• Chronic smoking (ranked 7th for adults and 1st for high school students in nation)
• Smokeless tobacco use (ranked 1st in nation)
• Obesity (ranked 7th in nation)
• Hypertension
• Sedentary lifestyles (ranked 4th in nation)

West Virginia residents exhibit behavioral risk factors well above the national average, and the risk factors in CAMC's referral region exceed the state average.

• Total cardiovascular diseases are the most common cause of death in the state, accounting for 40% of all deaths. West Virginia is ranked 4th in the nation for rates of death due to total cardiovascular diseases.
• Cancer is the second most common cause of death in the state, accounting for 25% of all deaths in West Virginia. Lung cancer (WV ranked 1st in the nation for rates of death due to lung cancer), colorectal cancer (WV ranked 19th for rates of death due to colorectal cancer), and breast cancer (WV ranked 43rd for rates of death due to breast cancer) are the three most common killers in the state. West Virginia is ranked 7th in the nation for rates of death due to all cancers. Southern West Virginia has a significantly higher incidence of lung cancer than the rest of the nation, particularly among males (23% versus 13%).
• COPD is the third most common cause of death in West Virginia. The state is ranked 1st in the nation for rates of death due to COPD.
• Diabetes is the fifth most common cause of death in WV. It affects more than 25% of West Virginians by the time they reach 65 years of age. The state is ranked 10th in the nation for rates of death due to diabetes.
• Prevalence of end-stage renal disease in West Virginia is markedly higher than the national rate.
• Estimates of men and women in West Virginia aged 50 and over who have osteoporosis are higher than national estimates.
• West Virginia's overall death rate was ranked 1st in the nation in 1996.
• West Virginia ranked 30th in the nation for rates of death due to stroke.

In addition, CAMC was rated as one of the best facilities for neurosciences and neurology in U.S. News and World Report's 1999 guide to America's Best Hospitals. Out of 50 health care facilities acknowledged for excellence in neurology and neurosciences in the U.S., CAMC was ranked 35th.

Other Information

Our staff is experienced with using Remote Data Entry.

Contact Information

For more information, please contact:

Clinical Trials Operations Manager
CAMC Institute
Clinical Trials Center
3100 MacCorkle Avenue, S.E.
Suite 306
Charleston, WV 25304 USA
Phone: 304-388-9934
Fax: 304-388-9935
E-mail: dan.lucas@camc.org