Clinical Trial Resource Center

Therapeutic Areas

Cardiology/Vascular Diseases
Endocrinology
Gastroenterology
Genetic Disease
Hematology
Immunology
Infections and Infectious Diseases
Nephrology
Neurology
Oncology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Trauma (Emergency, Injury, Surgery)

Center Overview

The Clinical Research Department of The William W. Backus Hospital was established in September 2000 to support the efforts of Hospital staff participating in clinical trials. The department is strongly supported by Hospital Administration and is recognized for providing an important benefit to the Hospital and community.

The Clinical Research Department can contract for a study directly and be responsible for the overall coordinating of the study, or a Hospital-affiliated physician who has recruited a study can contract with the department for specific research services.

Clinical Research Experience

Our hospital has conducted Phase II-Phase IV clinical trials in oncology, diabetes, cardiology, HIV, rheumatology and psychiatry for the last 15 years. Other projects have included registries of Deep Vein Thrombosis, Acute Coronary Syndrome, and Congestive Heart Failure; studies on gene expression of human joint tissue and Community-Acquired Pneumonia.

Our site has worked with a variety of sponsors and CROs, such as:

Facility Description

The William W. Backus Hospital is a 213-bed acute care community hospital. Fully accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and licensed by the State of Connecticut, Backus Hospital is the primary source of acute care health services for some 150,000 people in eastern Connecticut.

Backus Hospital is a Level 2 Trauma Center and has an Air Medical Support Facility. As the state's only designated Trauma Center east of the Connecticut River, Backus Hospital is the sole regional facility that can receive, via emergency helicopter, patients with severe traumatic injuries.

The Hospital also boasts several specialized services: The Psychiatric Services Department includes an 18-bed inpatient facility, partial hospitalization program and outpatient Mental Health Clinic. Backus Hospital has a state-of-the-art Diagnostic Cardiac Catheterization Laboratory, as well as the Dr. Sultan Ahamed Radiation Therapy Center. Backus has opened a new Outpatient Care Center a few miles from the Hospital. Outpatient services at this location include: diabetes, wound care, and other endocrine-related disorders, as well as a rheumatology department, foot clinic, ostomy clinic, education rooms and a research area. Also housed in the center are a blood draw station, a diagnostic imaging center and an anti-coagulation clinic. The Hospital will continue to develop the site as community needs are identified. The Diabetes Management Center, accredited by the American Diabetes Association, includes a multi-disciplinary team consisting of board-certified endocrinologists, certified diabetes educators, registered dieticians and nurse specialists.

Specialized diagnostic imaging equipment includes: Positron Emission Tomography (PET), Bone Densitometry, CT Scan, Magnetic Resonance Imaging (MRI), Nuclear Medicine Imaging and Stereotactic Breast Biopsy.

Backus Hospital has twelve contemporary Operating Room suites where complex surgical procedures are performed, including laser, lithotripsy, neurosurgery, orthopedic, total hip and knee replacement, plastic, radial keratotomy, retinal, thoracic, urology and vascular.

The Laboratory, Pharmacy, and Diagnostic Imaging departments, among others, are in full support of clinical research at the hospital. All research is coordinated through the Clinical Research Department to facilitate study processes.

The Hospital is easily accessible from two major highways, Routes 2 and 395. Local public transportation stops at the Hospital's main entrance. This site is approximately one hour from two international airports, Providence, RI and Hartford, CT. Local attractions include Olde Mystic Village, Mystic Seaport, and Mohegan Sun and Foxwoods Casinos. Norwich is within two and one-half hours from New York City and two hours from Boston.

Investigator Experience

Diabetes

Ria Lim, M.D.
Endocrinologist, Backus Diabetes Management Center
Board Certified in Internal Medicine
Research Experience:
Sub-Investigator on several clinical trials in diabetes and related disorders

Cardiology

John Foley, M.D., FACC
Director of Heart Failure Services, The William W. Backus Hospital
Attending Cardiologist, Cardiology Associates, Norwich, CT
Clinical Instructor of Medicine, Yale University Medical School
ACLS Instructor, American Heart Association
Board Certified in Internal Medicine and Cardiovascular Disease
Research Experience:
Principal Investigator - A Randomized, Double-Blind, Placebo-Controlled Study of Two Intravenous Dosing Regimens of h5G1.1-scFv in Patients with Acute Myocardial Infarction Undergoing Thrombolytic Reperfusion Therapy [Complement Inhibition in Myocardial Infarction Treated With Thrombolytics (COMPLY)], Procter & Gamble Pharmaceuticals
Principal Investigator – Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure [Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study With Tolvaptan (EVEREST)], Otsuka Maryland Research Institute
Principal Investigator - A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular Artial Fibrillation
Principal Investigator on an Acute Coronary Syndrome registry, a Heparin-Induced Thrombocytopenia registry and two Congestive Heart Failure registries

Faisal Hasan, M.D., F.A.C.C.
Attending Cardiologist, Cardiology Associates, Norwich, CT
Clinical Instructor of Medicine, Yale University Medical School
Board Certified in Internal Medicine and Cardiovascular Disease
Research Experience:
Principal Investigator - A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP
Sub-Investigator on several clinical trials in cardiology

Oncology

Dennis Slater, M.D.
Attending Oncologist, Eastern Connecticut Hematology and Oncology, Norwich, CT
Medical Staff Member, The William W. Backus Hospital
Board Certified in Internal Medicine and Medical Oncology
Research Experience:
Principal or Co-Investigator on multiple oncology clinical trials over the last 15 years

Mandeep Dhami, M.D.
Attending Oncologist/Hematologist, Eastern Connecticut Hematology and Oncology
Medical Staff Member, The William W. Backus Hospital
Board Certified in Internal Medicine, Medical Oncology and Hematology
Research Experience:
Principal or Co-Investigator on multiple oncology clinical trials

Kandhasamy Jagathambal, M.D.
Attending Oncologist/Hematologist, Eastern Connecticut Hematology and Oncology
Medical Staff Member, The William W. Backus Hospital
Board Certified in Internal Medicine, Medical Oncology, Hematology, Blood Banking and Transfusion
Research Experience:
Principal or Co-Investigator on multiple oncology clinical trials

Dinesh Kapur, M.D.
Attending Oncologist/Hematologist, Eastern Connecticut Hematology and Oncology
Director, Oncology Services, The William W. Backus Hospital
Board Certified in Internal Medicine, Medical Oncology and Hematology
Research Experience:
Principal or Co-Investigator on multiple oncology clinical trials

Psychiatry

Mahmoud Okasha, M.D.
Medical Director, Comprehensive Psychiatric Care, Norwich, CT
Medical Staff Member, The William W. Backus Hospital
Board Certified in Psychiatry & Neurology and Psychiatry
Research Experience:
Principal Investigator - A Comparison of Fasting Triglyceride Levels in Cohorts with Schizophrenia and Related Disorders Treated Chronically with Olanzapine, Risperidone, and Typical Antipsychotics (Eli Lilly & Co.)
Principal Investigator - A Phase IIB, Seven-Week, Double-Blind, Placebo- and Paroxetine-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Oral CP-122,721 in Outpatients with Major Depressive Disorder and Associated Somatic Symptoms (Pfizer)
Plus multiple other clinical trials in depression, depression in the elderly, alzheimer's disease and bipolar disorder

Infectious Disease/HIV

Clifford Stirba, MD
Medical Director, Infectious Disease Clinic of Norwich
Medical Staff Member, The William W. Backus Hospital
Private Practice, Norwich, CT
Research Experience:
Principal Investigator – Multicenter, Open-Label, Early Access Program of Enfuvirtide (FUZEON (T-20)/Ro 29-9800, HIV-1 Fusion Inhibitor) in Combination with Free Choice Antiretroviral Regimen to Assess Serious Adverse Events, Serious AIDS Defining Events, and Tolerabilty in Patients with Advanced HIV-Infection (Hoffmann-La Roche, Inc. and Trimeris Inc.)
Principal Investigator – An Open Label, Non-randomized Treatment Protocol of Tipranavir Co-administered with Low-dose Ritonavir (TPV/r) in Protease Inhibitor-experienced Patients with HIV-1 Infection (the Tipranavir Expanded Access Program) (Boehringer Ingelheim Pharmaceuticals, Inc.)
Principal Investigator – Early access of TMC114 in combination with low-dose ritonavir (RTV) and other antiretrovirals (ARVs) in highly treatment experienced HIV-1 infected subjects with limited to no treatment options (Tibotec Pharmaceuticals, Inc.)
Plus multiple other trials in infectious disease

Rheumatology

Sandeep Varma, MD
Director, Backus Department of Rheumatology
Board Certified in Rheumatology
Masters Degree in Clinical Evaluative Sciences
Research Experience
Principal Investigator - A Long-Term Study Of The Safety Of Rituxan In Patients With Rheumatoid Arthritis After An Inadequate Response To Previous Anti-Tnf Therapy (Sunstone)
Principal Investigator - The CORRONA Data Collection Program

Harjinder Singh Chowdhary, MD
Rheumatologist, Backus Department of Rheumatology
Board Certified in Internal Medicine
Research Experience:
Principal Investigator - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (Illuminate-1)
Co-Investigator – Use of Nitroglycerine Ointment in Raynauds
Co-Investigator – monoclonal antibody in SLE by RITUVA
Co-Investigator – Scleroderma-pulmonary Hypertension Registry

Please contact us for more detailed investigator credentials and current CVs.

Staff Expertise

Paula B. Provost, Ed.M.
Research Protocol Coordinator
18 years experience in clinical research (psychiatry, cardiology, diabetes, HIV, other)
Member of the Association of Clinical Research Professionals

Barbara Beene, R.N., C.D.E.
Diabetes Nurse Educator and Clinical Coordinator, Backus Diabetes Management Center
10 years experience in clinical research

Ann Hartman, RN
Clinical Coordinator, Infectious Disease Clinic of Norwich
10 years experience in clinical research

Per diem Research Assistants on staff.

Patient Demographics

The Hospital's catchment area consists of some 150,000 people. Breakdown by age and gender is as follows:

Breakdown by ethnicity is as follows:

This site has been successful in meeting or exceeding recruitment goals for patients suffering from acute myocardial infarction or congestive heart failure, insulin-naïve patients, HIV patients, patients with various forms of cancer, and patients with depression.

Other Information

The Hospital has an Institutional Review Board which meets monthly, with a submission deadline of 14 days prior to the meeting.

The Hospital has an electronic medical record system which makes data abstraction and trial pre-screening much more efficient.

Contact Center

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