West Virginia University's Clinical Trials Research Unit (CTRU) is dedicated to providing the services and expertise that investigators need to conduct clinical trials and expand the growing body of biomedical knowledge. We offer a wide range of administrative and budgetary services to both clinical investigators and private industry.

Because West Virginia University is the state's primary research institution, the CTRU physicians represent a comprehensive range of specializations. Our staff has a sterling reputation for excellent patient care as well as timely delivery of valid and reliable data.

Unlike many other academic health centers, West Virginia University provides primary care services to a large, stable population of rural patients. WVU also provides secondary and tertiary care. Our patient population ensures a high degree of follow-up care and study completion that many other clinical trials facilities cannot offer.

WVU clinical investigators have a long history of conducting both industry sponsored and investigator initialized research. The CTRU was created nearly 10 years ago to help further the clinical research efforts in all therapeutic areas at WVU hospitals and the Health Sciences Center.

Since the CTRU represents the entire WVU Health Sciences Center, the CTRU is the only administrative unit you need to communicate with during the clinical trial process. With a single phone call or e-mail to the CTRU, you can request information about our investigators, programs, and resources and initiate the process of formalizing a clinical trial agreement.

The CTRU provides our industry clients with services throughout the entire clinical trial process. Some of our offerings are:

• Establishment of cost centers
• Oversight of the receipt and disbursement of funds
• Compilation of retrospective information on patient enrollment
• Data management
• Computer-based reconciliation of clinical expenses
• Computerized event monitoring to identify potential study participants as they are admitted to the hospital or seen in the outpatient clinics
• "Standard Contract Template" The template allows the modification and customization to fit the needs of a particular study.

Amgen Aventis Bristol-Myers Squibb Eli Lilly Genentech Glaxo SmithKline Johnson and Johnson Merck & Co. Novartis

Ortho-McNeill Parke-Davis Pfizer Pharmanet Covance ICON Clinical Research PPD Development Quintiles And many more

The CTRU is a part of the Mary Babb Randolph Cancer Center (MBRCC) at West Virginia University's Robert C. Byrd Health Sciences Center (HSC) and serves all of the HSC. With more than one million square feet of classroom, laboratory, library, clinical, and office space, the HSC is West Virginia's flagship institution for health care, education, and research. The HSC has won national recognition for its innovative programs and commitment to raising the quality of health statewide.

Our Schools of Dentistry, Medicine, Nursing, and Pharmacy offer a comprehensive range of undergraduate, graduate, and professional degrees in health care and biosciences. The degree programs offered by the HSC have developed a strong group of professionals prepared to meet the varied health care needs of the state and nation.

Clinical trials are conducted at the Mary Babb Randolph Cancer Center (MBRCC) and the Robert C. Byrd Health Sciences Center (HSC) at West Virginia University in Morgantown, West Virginia. Located in northern West Virginia, Morgantown is easily accessible from Pittsburgh, PA (77 miles) and Washington, DC (218 miles).

WVU clinical investigators represent the thought leaders in many specialized areas. Examples include: Oncology, Surgery, Cardiovascular Specialties, Neurology, Pulmonary, Critical Care, Pediatrics, Neonatology, Infectious Diseases, Behavioral Medicine, Pharmacokinetics and Pharmacogenomics.

With over 100 years of combined nursing experience, all of our study coordinators are screened for a high commitment to quality clinical practice. These registered nurses work closely with West Virginia University's diverse faculty to ensure consistent, reliable care. They also handle submissions to the University's Institutional Review Board (IRB), a highly respected organization that ensures adherence to Federal standards and guidelines.

West Virginia University provides primary, secondary and tertiary care services to over 600,000 patients. Most of these patients are from rural communities and represent a stable population. Our patient population ensures a high degree of patient compliance that many other clinical trials facilities cannot offer.

The CTRU is adept at helping clinical researchers understand and navigate WVU's clinical trials system. The three tracks that comprise the Health Sciences protocol, contract, and budget approval processes are:

• Institutional Review Board (IRB)- WVU maintains 2 local IRBs and each meets 1 time per month.
• Office of Sponsored Programs (OSP)- works closely with the CTRU in contract development, budget negotiations and seeking all necessary administrative approvals
• Regulatory Documents

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

• A Multicenter, Open-Label, Randomized, Phase II/III Study to Evaluate the Safety and Efficacy of Combretastatin A-4 Phosphate in Combination with Paclitaxel and Carboplatin in Comparison with Paclitaxel and Carboplatin Against Anaplastic Thyroid Carcinoma (OXC4T4)
• A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects with Severe Lung Disease (TOPIC)
• A Phase 3, Multicenter, Randomized, Evaluation Committee-Blinded Study to Assess the Efficacy of Topical Administration of Omiganan 1.0% Gel in Preventing Local Catheter Site Infections and Catheter Colonization in Patients Undergoing Central Venous Catheterization.
• A Phase 3b, Open-Label, Single-Group Immunogenicity and Safety Study of Topical Recombinant Thrombin (rThrombin) in Surgical Hemostasis
• A Phase II Randomized Trial of BAY 43-9006, a Novel Raf Kinase Inhibitor, versus BAY 43-9006 plus Paclitaxel/Carboplatin in Women with Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer (CASE 2804)
• A Phase III Study of SU011248 in Combination with Paclitaxel versus Bevacizumab with Paclitaxel in the First-Line Advanced Disease Setting in Patients Having Breast Cancer (A6181094)
• A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency (Altus 0000726)
• A Prospective, Multi-Center, Randomized, Controlled Clinical Study Comparing SyntheCel Dura Replacement to Other Dura Replacements in Patients Requiring Dura Repair Following Cranial Surgery.
• A Randomized, Open Label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder (TIP) Compared to TOBI in Cystic Fibrosis (CF) Subjects (TIP 003)
• Carotid Stenting for High Surgical Risk Patients; Evaluating Outcomes Through the Collection of Clinical Evidence (CHOICE)
• Cognitive Function in Cancer Chemotherapy (CFCC)
• Evaluation of Molecular Abnormalities of Potential Relevance to the Efficacy of Targeted Anticancer Treatment in Lung and Head & Neck Cancers (EGFR)
• Examination of PNH, by Level Of CD59 on REd and white blood cells, in bone marrow failure syndromes (EXPLORE)
• Multi-Center, Multi-National, Randomized, Placebo-Controlled Trial of Azithromycin in Subjects with Cystic Fibrosis 6-18 years old, Culture Negative for Pseudomonas aeruginosa (AZ0004)
• Quantitative Determination of Substance P Concentrations in Blood, Saliva, and Urine of Patients Receiving Chemotherapy of Moderate to High Emetogenic Potential (Aprepitant)

For more information, please contact:

John Naim, Ph.D.
Director
West Virginia University - Clinical Trials Research Unit
1637 Health Sciences South
PO Box 9260
Morgantown, WV 26506 USA
Phone: 304-293-4944
Fax: 304-293-8698
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.

Name:
Address:
City:
State:
Zip:
Phone:
Email address:
Message:

Please note: A number of commercial online services display an error message after you click on Send. Please be assured that your message has been received.

Last updated on May 1, 2008

PAC>