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Research

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Research

You know, those kids who asked for chemistry sets for their birthdays and actually used them.

What is The Research Department?

Modern medicine is driven forward through research at every level—biomedical, experimental, clinical, and many others. From tried and true approaches, to new paradigms, medical research touches nearly every component of medicine, and can involve public health, biochemistry, clinical research, microbiology, physiology, oncology, and surgery, plus research into communicable and non-communicable diseases.

How We Are Different

The Research Department is active and growing at The Vancouver Clinic. On any given day you may run into one of the staff in Endocrinology, Rheumatology, or Pediatrics as well as the Cardiology department (where our office resides).

Some of our recent studies and trials include diabetes medications, pediatric vaccines and Hepatitis C clinical trials. You may have heard about the new Rheumatoid Arthritis medication, Xeljanz. Our department is proud to have been involved in the development and FDA approval of this medication, which provides significant relief for patients. And we are currently in the midst of a follow-up extension study with Xeljanz in order to continue collecting safety data the FDA requires.

About Clinical Trials

To test the effectiveness of a new medical treatment, drug or device with patients, researchers conduct a scientific study called a clinical research trial. The trial may show that the investigational treatment is better than, as good as, or no better than the standard treatment for the same condition. Clinical trials may produce successful treatment for diseases which have had no treatment in the past. The Food and Drug Administration (FDA) requires clinical research trials before it can approve a new treatment as safe and effective for public use.

A clinical research trial is a partnership and a commitment between doctors and volunteer patients. It is the final test in a series of many carefully controlled scientific studies. Clinical trials and studies in the following areas:

  • Diabetes – Type I and Type II
  • Rheumatoid arthritis
  • Hypoparathyroidism
  • Ulcerative Colitis
  • Pediatric vaccines
  • Follow-up extension studies that ensure the quality and safety
  • Crohn’s Disease
  • Ankylosing Spondylitis
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Service Information

Participation

Making the Decision to Participate

There are two reasons to participate in a clinical research trial: to help yourself and to help others.

It is possible the treatment being tested will improve your health. A new drug or new procedures may reduce pain or perhaps even cure your illness. All clinical research trial patients receive a great deal of personal medical attention.

You may also decide to participate in a clinical research trial for the satisfaction that comes from being a part of scientific research. Many people hope for a breakthrough treatment that will make coping with an illness easier or eliminate it altogether. Clinical research trial volunteers help make those discoveries available to people all across the country and around the world.

Being a volunteer is a serious commitment. Deciding to participate in a clinical research trial means weighing possible benefits against possible risks. You should only make the commitment to participate in a clinical research trial after you have carefully discussed all the facts with your doctor and/or the research study coordinator.

Open Enrollment

Crohn’s Disease

A Phase 3, Randomized, Placebo-controlled, Double-blind, Multicenter, Induction Study to Investigate the Efficacy and Safety of GED-0301 For the Treatment of Subjects With Active Crohn’s Disease

Purpose

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn’s disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn’s disease.

After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study.

Eligibility

Inclusion Criteria:

  • Subjects must satisfy the following criteria to be enrolled in the study:
  • Male or female ≥ 18 years
  • Active Crohn’s disease
  • Subject must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of CD.

Rheumatoid Arthritis

A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)

Purpose

This is a phase 3, randomized, double-blind study comparing ABT-494 to Placebo and to Adalimumab (Humira) in subjects with moderately to severely active rheumatoid arthritis who are on a stable background of Methotrexate (MTX) and who have an inadequate response to MTX.

Eligibility

Inclusion Criteria:

  • Adult male or female, at least 18 years old.
  • Diagnosis of RA for greater than or equal to 3 months.
  • Subjects must have been on oral or injectable methotrexate (MTX) therapy

Ankylosing Spondylitis (AKA Spondyoarthritis)

A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis (COAST-W)

Purpose

The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA).

Eligibility

Inclusion Criteria:

  • Are ambulatory.
  • 18 Years and older (Adult, Senior)
  • Have an established diagnosis of radiographic axial spondyloarthritis (rad-xSpA) with sacroiliitis defined  radiographically according to the modified New York criteria.
  • Participants have a history of back pain ≥3 months with age at onset <45 years.
  • Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.

Ankylosing Spondylitis (AKA Spondyoarthritis)

A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis (COAST-V)

Purpose

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive participants with radiographic axial spondyloarthritis (rad-axSpA).

Eligibility

Inclusion Criteria:

  • Are ambulatory.
  • 18 Years and older (Adult, Senior)
  • Diagnosis of radiographic axial spondyloarthritis (rad-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
  • Participants have a history of back pain ≥3 months with age at onset <45 years.
  • In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (for duration 4 weeks) or cannot tolerate NSAIDS.

Non-radiographic Ankylosing Spondylitis (AKA Spondyoarthritis)

A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis (COAST-X)

Purpose

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).

Eligibility

Inclusion Criteria:

  • Are ambulatory.
  • 18 Years and older (Adult, Senior)
  • Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the 2009 ASAS classification criteria.
  • Have a history of back pain ≥3 months with age at onset <45 years.

Contact Information:

The Vancouver Clinic
Research Department
Direct Line: 360-397-3388
research@tvc.org

FAQS

Who conducts clinical research trials?
Pharmaceutical companies, research institutions, or other health organizations sponsor a clinical research trial. Sponsors are responsible for funding and for designing the trial protocol (the set of detailed guidelines that investigators follow in order to conduct the same clinical research trial at different locations). Trained doctors, nurses, and medical researchers conduct the trials.

What is a clinical research trial like?
Participating in a clinical research trial is much like a regular visit to a doctor’s office, but with even greater personal attention. The success of any trial depends on its volunteers. Patients are treated professionally and with care.

What are the risks?
Risks vary from trial to trial. Known risks and discomforts will be explained by the study physician prior to each patient’s participating in the study. In addition to the known risks, there may be unknown risks such as medication side effects. While it is possible that some side effects could be permanent or even life threatening, most are temporary and will go away as soon as the treatment is stopped.

Will I be compensated?
There are no patient charges for medical services rendered to participants of clinical research studies. Medical tests and physician services associated with the study, in addition to the substance, procedure, or device being tested, are provided to participating patients. Some studies also include a stipend paid to participants for their involvement in the project as reimbursement for time and travel. This amount varies, depending on the nature of the study and the patient involvement.

Are there requirements for volunteers?
Each trial has certain requirements (for example: diagnosis, medical condition, and age), and patients must meet these requirements. The physician conducting the study will review each volunteer’s medical history and the study requirements to determine who can participate. Once a patient is enrolled in the trial, there are very specific guidelines which must be followed.

For the eligibility requirements for a particular trial, contact the Research Department at The Vancouver Clinic to speak to the coordinator for that study.

What is expected of volunteers?
Volunteers need to be at appointments on time, to follow instructions carefully, to return phone calls from the study coordinator, and especially to take any medication exactly as told. This is needed in order to collect the information necessary for a successful study.

What can volunteers expect from the clinical research trial team?
Prior to enrolling in a trial, volunteers should expect to receive complete information about the trial. They should not participate in any clinical research trial unless their questions have been reasonably answered.

Study procedures, risks and benefits are explained to volunteers during the informed consent process. This is required by law to make sure volunteers understand what is involved in a trial.

Volunteers can also expect complete information about the schedule and duration of the trial, directions to the trial location, and the name of someone to contact with questions or problems.

Are volunteers protected?
As patients under doctor’s supervision, volunteers are protected by the same laws and ethics that normally regulate the medical profession. Informed consent helps protect volunteers by making sure they have been given all the necessary information about a trial. An institutional review board (IRB) reviews the general progress of the trial. The IRB also regulates clinical research trial advertisements to reduce misleading claims.

Can volunteers change their minds after a clinical research trial starts?
Volunteers are always free to change their minds and stop participating in a trial at any time. They should keep in mind, however, that when even a few patients stop participating mid-trial (because of disinterest or other reasons), there may not be enough patients remaining to achieve reliable results.

How do you become a medical researcher?
The field of medical research continues to grow, thanks in part to innovation that leads to new treatments and tools for prevention and health maintenance. There are a number of pathways you can follow for a career in medical research, including certain MD-PhD programs that provide training for students who wish to become research physicians (or physician investigators). Another path involves receiving a PhD in biomedical sciences.

What type of person becomes a medical researcher?
Medical researchers tend to have a keen interest in contributing to the greater body of medial knowledge available to professionals for the sake of their patients. Medical researchers must possess a sharp intellect, in addition to the emotional strength it takes to complete an advanced degree. The best researchers also possess strong communications skills, which helps them draft grant proposals and communicate their findings.

What’s driving the growth of medical research as a career?
Many people point to the simple fact that we’re living longer as to why medical research, as a field, continues to grow. Here’s another thing to consider: humans have been trying to make ourselves better for as long as we’ve been getting sick. In that way, medical research goes back to the beginning of time. In the first half of the 20th century, it led to countless breakthroughs—vaccines for measles and polio; insulin treatment for diabetes; antibiotics that any number of illnesses. More recently, medical research has improved HIV/AIDS treatments, has spurred new surgical techniques such as microsurgery, and has forged successful treatments for types of cancer that, a quarter century ago, were almost always fatal. As challenges remain, medical researchers continue to step forward and meet them head-on.

Questions to ask your doctor before participating in a clinical research trial:

  • What is the purpose of the trial?
  • What treatments will be done and how?
  • How will patient safety be checked?
  • What are the possible side effects and risks of this treatment?
  • How could this treatment benefit me?
  • What treatments, other than the one being tested, are available for the same condition?
  • How will the trial affect my daily life?
  • How long will the trial last?
  • Who is sponsoring the trial?
  • Will I have to pay for anything?
  • What happens if I am harmed by the trial?
  • Will I be able to stay on this treatment when the trial is over?
Definitions

Clinical Research Trial
A scientific study that tests the effectiveness of a new medical treatment, drug, or device with patients. Also referred to as a “study.”

Clinical Investigator
A medical researcher in charge of carrying out a clinical research trials protocol. This could be a doctor, dentist, or other health care professional.

Food and Drug Administration (FDA)
The government agency that sets guidelines on the manufacture, testing, and use of drugs and medical devices. All drugs and medical devices must be approved by the FDA before they can be used by the general public.

Informed Consent
The complete and open discussion of all procedures, benefits, risks, and expectations of a clinical research trial between clinical investigators and patients. The FDA requires all patients to sign an informed consent form before participating in a trial.

Institutional Review Board
A group of health care professionals, scientists, clergy and lay leaders, and members of the local community who are independent from the sponsor or research center and who must approve the research trial’s methods and goals before the research can begin. The board makes sure all FDA and protocol regulations are followed and reviews all trial activities, including recruitment and advertising and potential risks.

Investigational Treatment
The drug or device being tested during a clinical research trial.

Pharmaceutical Company
A business that researches, develops, tests, manufactures, and/or sells medical drugs and devices.

Protocol
A detailed plan carefully designed by a clinical research trial sponsor. It sets guidelines for a trial and usually involves several different trial locations. The investigator is responsible for seeing that the protocol is followed at his/her site.

Sponsor
The pharmaceutical company, research institution, or other health organization that funds a clinical research trial and designs its protocol.

Standard Treatment
A treatment currently in wide use and approved by the FDA for a particular disease or illness. In some trials involving new investigational treatments, there may be no pre-existing treatment at all. In these cases, the lack of any treatment is itself considered the standard treatment. Generally, the investigational treatment is hoped to be safer and more effective than the standard treatment.

Study Coordinator
A nurse or other health care worker who has been specially trained in conducting clinical trials. The study coordinator works with the investigator, and schedules patient visits, educates patients on medications. She is also available to answer questions or address problems volunteers in a study may have.

Sponsor Info

Our Facilities
The Vancouver Clinic is the largest multi-specialty group practice in Vancouver, Washington. There are 250+ physicians and mid-level providers in five locations in Clark County. Vancouver is located along the Columbia River adjacent to the Portland, Oregon metropolitan area and 12 miles from the Portland International Airport.

Diagnostic services include fully accredited laboratory, full imaging services (diagnostic radiology, mammography, ultrasound, CT, MRI, bone densitometry (DEXA)), ECG and monitoring services, an infusion center, pulmonary function lab, cardiac testing (treadmill, Holter, nuclear studies), Ambulatory Surgery Center and a 10-bed Sleep Center.

Patient Demographics
The population of Clark County is approximately 400,000. The Clinic’s active patient population (seen in the last 2 years) is roughly 125,000 patients.

Hospital Affiliations
Physicians at The Vancouver Clinic are affiliated with PeaceHealth Southwest Medical Center, located four blocks from the main Clinic campus. Many physicians are also affiliated with Legacy Salmon Creek Hospital, located approximately 8 miles from the main Clinic campus.

Industry Services
Secure and controlled building access and patient areas
Secure, climate-controlled drug storage
Patient management database and electronic medical record
Excellent FDA audit record
We utilize central IRBs
-20 C freezer
Refrigerated centrifuge

Research Department Staff
Medical Director for Research: Marcia Sparling, MD

Department Manager: Laurie Swanson

Coordinators:
Nicole Gentes, MA, CRC
Mary Madura, MA, CRC
Marty O’Quin, MA, CCRC

Contact Information:
Phone: 360-397-3388
Fax: 360-604-1752
Email: research@tvc.org