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.
Examples of Sponsors/CROs with which the CTRU is currently or has worked with in the past:
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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.
Cardiology/Vascular Diseases
Dental/Maxillofacial Surgery
Dermatology/Plastic Surgery
Endocrinology
Gastroenterology
Hematology
Immunology/Infectious Diseases
Musculoskeletal
Nephrology/Urology
Neurology
Obstetrics/Gynecology
Oncology
Ophthalmology
Otolaryngology
Pediatrics/Neonatology
Pharmacology/Toxicology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Trauma/Emergency Medicine
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).
John Naim, Ph.D.
Director
West Virginia University - Clinical Trials Research Unit
1637 Health Sciences South
PO Box 9260
Morgantown, WV 26506
USA
304-293-4944
304-293-8698 (fax)
jnaim@hsc.wvu.edu
www.hsc.wvu.edu/mbrcc/ctru
- (CIRB Study) CALGB 10603: Phase III Randomized, Double-Blind Study of Induction and Consolidation plus Midostaurin or Placebo in Newly Diagnosed Patients Less than 60 with FLT3 Mutated Acute Myeloid Leukemia
- (CIRB)ECOG 1505: Ph3 Randomized Trial of Adjuvant Chemotherapy with or without Bevacizumab for pts with Completely Resected Stage IB-IIIA NSCLC
- (CIRB)ECOG 5103: A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
- 0822GCC: A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination with Either Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer Patients.
- 2010EAP: An Open-Label, Expanded Access Protocol of BSI-201 in Combination with Gemcitabine/Carboplatin in Patients with ER-, PR-, and HER2-Negative Metastatic Breast Cancer.
- 273-08-201: A Multi-center, Phase 2, Single-Arm, Open-label Exploratory Study of Individually Optimized Conditioning Using PK-directed Dose Adjustment of Once Daily Intravenous Busulfan, Followed by Autologous Hematopoietic Stem Cell Transplant in Subjects with Non-Hodgkin's Lymphoma and Hodgkin's Lymphoma
- 3144A2-3004-WW: A Randomized Double-blind Placebo-Controlled Trial of Neratinib (HKI-272) After Trastuzumab in Women With Early-Stage HER-2/neu Overexpressed/Amplified Breast Cancer
- ACOSOG Z1071: A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following reoperative Chemotherapy in Women with Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis
- ACOSOG-Z5041: Ph2 of Neoadjuvant and Adjuvant Gemcitabine Hydrochloride and Erlotinib Hydrochloride in pts + Resectable Adenocarcinoma of the Pancreas Undergoing Pancreatectomy.
- BMTCTN-0701: Phase II Trial of Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for Patients with Relapsed Follicular Non-Hodgkin's Lymphoma Beyond First Complete Remission
- CALGB50303 - Phase III Randomized Study of CHOP v. Dose-Adjusted EPOCH-R with Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphoma
- Carotid Stenting for High Surgical Risk Patients; Evaluating Outcomes Through the Collection of Clinical Evidence (CHOICE)
- CIRB) NSABP B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
- ECOG 10404: Randomizewd Ph2, Three Fludarabine/Antibody Combinations for patients with Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia
- ECOG 3903: Laboratory Protocol for Collecting Diagnostic Material for ECOG Treatment Trials for Leukemia or Related Hematologic Disorders.
- GSK 111482: A Double-Blind, Randomized, Placebo-Controlled Phase III Study to Assess the Efficacy of recMAGE-A3 Plus an Antigen Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients with MAGE-A3 Positive Resected Stage III Melanoma
- H3E-US-JMIG: Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed versus Etoposide, Cisplatin, and radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other than Predominantly Squamous Cell Histology.
- H3E-US-S130: Randomized, Open-Label, Phase 3 Study of Pemetrexed plus Carboplatin Followed by Maintenance Pemetrexed versus Paclitaxel plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients with Advanced Non-Small Cell Lung Cancer of Nonsquamous Histology
- I Change Adherence and Raise Expectations (iCARE)
- MI-CP204: An Open-label, Ph1/2 Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD 19, in Adult Subjects with Relapsed or Refractory Advanced B-cell Malignancies.
- NCI 7037/CASE 5304: Ph2 Trial of BAY 43-9006 in Patients with Advanced Anaplastic Carcinoma of the Thyroid.
- NSABP B-41: A Randomized Phase III Trial of Neoadjuvant Therapy for Patients with Palpable and Operable HER2-Positive Breast Cancer Comparing the Combination of Trastuzumab Plus Lapatinib to Trastuzumab and to Lapatinib Administered with Weekly Paclitaxel Following AC Accompanied by Correlative Science Studies to Identify Predictors of Pathologic Complete Response
- NSABP B-46-I / USOR 07132: A Phase III Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
- NSABP BP59: Bone Marrow Analysis in Early Stage Breast Cancer.
- OMB110918-A Randomized, Open Label Study of Ofatumumab and Bendamustine Combination Therapy Compared with Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment
- Quantitative Determination of Substance P Concentrations in Blood, Saliva, and Urine of Patients Receiving Chemotherapy of Moderate to High Emetogenic Potential (Aprepitant)
- S0816 - A Phase II Trial of Response Adapted Therapy of Stage III-IV Hodgkin's Lymphoma Using Early Interim FDG-PET Imaging
- SGL1003 - A Phase I Dose Escalation Study of Darinaparsin in Combination with CHOP in Previously Untreated Patients with Lymphomas Who are Scheduled to Receive CHOP Alone
- WVU11010 - Phase II study evaluating the safety and efficacy of Atorvastatin for the prophylaxsis of acute graft-versus-host disease in patients undergoing matched sibling hematopoietic stem cell transplantation
- WVU11310-Once daily intravenous Busulfex as part of reduced toxicity conditioning for patients with relapsed/refractory Hodgkin and non-Hodgkin lymphomas undergoing allogeneic hematopoietic cell transplantation - A multicenter phase II study.
- WVU1909: Unrelated Reduced Intensity Umbilical Cord Blood (UBC)Transplantation