- About BRI
- Contact Us
- Seminars
- Events / News
- Type 1 Diabetes Open House
- Oppurtunities for Giving
- Our Research
- For Patients and Public
- For Investigators
- Rasmuson
- Mission
- Actively Enrolling Clinical Trials
- Rasmuson Clinical Research
- Frequently Asked Questions
- Alaskan Clinical Trial Clinicians at Virginia Mason
- Alaska Community Events & News
- Contact Us
- Scientific Papers
- Quick Research Links
- Tetramer Info
- Employment
- VM Medical Center
- Site Map
Clinical Research
What is Clinical Research?
Clinical research projects are scientific studies in which people help doctors to improve health and health care for themselves and others. Many of today's treatments for illness are based on the result of past clinical research.
The Rasmuson Foundation recognizes that clinical research provides a special opportunity for Alaskans to improve personal health and advance medical knowledge. The Benaroya Research Institute at Virginia Mason is honored to help in this effort to benefit current and future Alaskans. Clinical Trials test new treatment for diseases. Translational Studies look for the causes of diseases in order to prevent and treat disease in the future.
Benaroya Research Institute's Clinical Research Program
Benaroya Research Institute at Virginia Mason (BRI) is dedicated to exploring the causes and cures of human disease. Key to this mission is innovation in clinical research. We are committed to staying at the forefront of our changing medical and scientific environments by combining expertise in laboratory investigation with breakthrough research. This bench-to-bedside approach allows for rapid development of scientific findings into medical treatment advancements with the potential to directly benefit people living with disease.
BRI's state-of-the-art facilities have been designed to offer both patients and researchers the most comfortable and efficient environment in which to conduct clinical trials. Our Clinical Research Center (CRC) in the Virginia Mason Medical Center is committed specifically to providing patients with the best possible treatment and oversight of research procedures - from simple interviews to the most sensitive of care. It is staffed by experienced and caring personnel who are specifically trained in the oversight of clinical trials. The CRC also offers trial participants shorter wait times, a relaxing environment in which to receive care, video and reading libraries, and other amenities to make participants visits relaxing and rewarding.
BRI's clinical research program is directed by Drs. Andrew Jacobs and Consuelo Blosch. Our Vision is to conduct the highest quality innovative clinical research, deploying the best resources of our clinical, basic science and translational research programs. Our Mission is to improve the health and well being of our patients and the community, using the tools of discovery. The program provides skilled physicians who lead our trials as Principal Investigators, and empathic care of our clinical trial participants from a highly experienced staff in the conduct of clinical trials. Our team includes Unit Managers, Clinical Research Coordinators, Research Assistants and knowledgeable administrative personnel (Institutional Review Board; Regulatory Compliance and Education; and office personnel). Our care of patients begins with a discussion with the patient which describes the clinical trial in detail, giving patients time to understand and ask questions to be able to make an informed decision to participate in a clinical trial. Our care of the patient continues with screening, or review, of the patient's medical history to determine if he/she meets entry criteria for a clinical trial; enrollment into a trial; and retention of the patient through the completion of the trial.
With hundreds of studies underway, there are many opportunities for both healthy volunteers and people living with disease to participate, and help contribute to a cure for diseases such as diabetes, arthritis, cancer, heart disease, and others.
Explore our research studies underway to get general information about research projects, or to find out about opportunities to participate in a clinical research study.
For more information about clinical research and specific diseases, see frequently asked questions, and other online resources.
Actively Enrolling Clinical Trials
Please call 1-800-354-9527 (Virginia Mason Hospital Operator). Ask for the coordinator listed under the trial(s) you are interested in participating and/or obtaining more information.
Heart Institute
(Cardiology)
Principal Investigator: Mark Hill, MD
Coordinator: Jill Zeller, RN
Email: Jill.zeller@vmmc.org
Cancer
(Oncology)
Principal Investigator: Andrew Jacobs, MD
Coordinator: Louise Soltow
Email: louise.soltow@vmmc.org
Principal Investigator: Andrew Jacobs, MD
Coordinator: Louise Soltow
Email: louise.soltow@vmmc.org
Principal Investigator: Thomas Malpass, MD
Coordinator: Marisa Cody
Email: Marisa.cody@vmmc.org
Principal Investigator: Henry Otero, MD
Coordinator: Louise Soltow
Email: louise.soltow@vmmc.org
Principal Investigator: Jacqueline Vuky, MD
Coordinator: Louise Soltow
Email: louise.soltow@vmmc.org
Digestive Disease Institute (DDI)
(Gastroenterology)
Principal Investigator: Richard Kozarek, MD
Coordinator: Nicoline Lomah
Email: Nicoline.lomah@vmmc.org
Efficacy and Safety of DNK333 in Women With Diarrhea-Predominant Irritable Bowel Syndrome
Principal Investigator: Otto Lin, MD
Coordinator: Nicoline Lomah
Email: Nicoline.lomah@vmmc.org
Neurology
Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-Remitting Multiple Sclerosis
Principal Investigator: Mariko Kita, MD
Coordinator: Leslie Stevens
Email: leslie.stevens@vmmc.org
XERECEPT® (hCRF) for Patients Requiring Dexamethasone to Treat Edema Associated With Brain Tumors
Principal Investigator: Lynne Taylor, MD
Coordinator: Jill Zeller, RN
Email: Jill.zeller@vmmc.org
Principal Investigator: Lynne Taylor, MD
Coordinator: Jill Zeller, RN
Email: Jill.zeller@vmmc.org
Urology
cG250 Monoclonal Antibody Vs Placebo for Renal Cell Carcinoma
Principal investigator: John Corman, MD
Coordinator: Kathryn Dahl
Email: Kathryn.dahl@vmmc.org
Principal Investigator: John Corman, MD
Coordinator: Erin Odom
Email: erin.odom@vmmc.org
Type 1 Diabetes
hOKT3gamma1 (Ala-Ala) in People Recently Diagnosed With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
Principal investigator: Carla Greenbaum, MD
Recruitment Coordinator: Christine Webber
Email: diabetes@benaroyaresearch.org
Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
Principal investigator: Carla Greenbaum, MD
Recruitment Coordinator: Christine Webber
Email: diabetes@benaroyaresearch.org
Natural History Study of the Development of Type 1 Diabetes Condition: Diabetes Mellitus, Type 1
Principal investigator: Carla Greenbaum, MD
Recruitment Coordinator: Christine Webber
Email: diabetes@benaroyaresearch.org
Frequently Asked Questions About Clinical Trials
Questions and answers in this section are included courtesy of the National Library of Medicine.
- What is a clinical trial?
- Why participate in a clinical trial?
- Where do the ideas for trials come from?
- Who sponsors clinical trials?
- What is a protocol?
- What is a placebo?
- What is a control or control group?
- Who can participate in a clinical trial?
- What happens during a clinical trial?
- What is informed consent?
- What are the benefits and risks of participating in a clinical trial?
- How is the safety of the participant protected?
- Can a participant leave a clinical trial after it has begun?
What is a clinical trial?
A clinical trial is a research study to answer specific questions about vaccines, new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.Where do the ideas for trials come from?
Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.Who sponsors clinical trials?
Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.What is a protocol?
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.What is a placebo?
A placebo i an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment.What is a control or control group?
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.What are the benefits and risks of participating in a clinical trial?
Clinical trials that are well-designed and well-executed are the best treatment approach for eligible participants to:Benefits:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
- There are risks to clinical trials.
- There may be unpleasant, serious or even life-threatening side effects to treatment.
- The treatment may not be effective for the participant.
- The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.  |
 |