Early access to promising new treatments
As a result of our work in research, patients of MultiCare Health System often have early access to promising medications and devices, radiation therapies, and surgical techniques that offer types of care that would not otherwise be available.
Taking part in a clinical trial offers multiple benefits, including:
- A chance to help others and improve treatment options
- Access to new treatments or medications
- Close monitoring of your health for any side effects
- Financial assistance with some of the costs of treatment during the clinical trial
- High-quality care
Clinical trials & studies
You’ve probably heard the phrase “clinical trials,” but do you know what that actually means?
Clinical trials are one of the final steps in a long research process. Before new treatments are used in research studies involving people, they’re tested in labs or on animals. Once people are involved, they’re called clinical trials.
Clinical trials aim to determine the safety and effectiveness of:
- A different dose of a medication than is commonly used
- A new medication or device on a specific kind of patient
- An already-marketed medication or device being used for a new purpose
Open clinical trials
A clinical trial is a research study in which volunteers receive investigational treatments under the supervision of a doctor and other research professionals.
Phases of clinical trials
Research related to whether a new treatment or medication is effective and safe includes multiple phases:
Phase II
This phase measures the safety and effectiveness of a medication given to people diagnosed with a specific medical condition. Many phase II trials use a process called randomization, in which some patients receive the investigational medication and others receive the standard treatment or placebo as part of a control group.
Phase III
These are randomized and blinded trials that provide more information about how the medication works, including side effects and long-term use.
Phase IV
This phase occurs after a medication has been approved by the FDA and can be obtained by a prescription. These trials compare the newly approved medication with similar medications currently in use to monitor its long-term effectiveness and impact on a patient’s quality of life.
Patient safety & rights
All clinical trials must be reviewed and approved by an Institutional Review Board (IRB). The IRB ensures the protection of the rights, safety and well-being of those participating in clinical research trials.
MultiCare has had an IRB since the early 1980s that includes both scientific and nonscientific members, along with both institutional and noninstitutional members, as required by the FDA and OHRP.
Frequently asked questions about participating in a study
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Why should I participate in a research study?
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Patients participating in research studies often have early access to promising investigational medications and devices, radiation therapies, and surgical techniques that offer types of care that would not otherwise be available. Patients are closely monitored for potential side effects during treatment.
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What is a clinical trial?
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A clinical trial is a research study in which volunteers receive investigational treatments under the supervision of a doctor and other research professionals.
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Who can participate?
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All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must qualify for the study based on certain criteria, which may include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Some research studies seek participants with specific illnesses or conditions to be studied in a clinical trial, while others require healthy participants.
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Where do the ideas for trials come from?
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For phase I–IV research, the ideas come from pharmaceutical or device companies. For outcome or comparative effectiveness research, the ideas come from our investigators, including doctors and nurses.
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How does a clinical trial work?
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In a clinical trial, a volunteer is usually assigned a specific study group. Volunteers in one study group may receive an investigational treatment or medication, while other volunteers may receive a placebo (an inactive product) or a treatment already available.
The participant, doctor and research staff may not know which volunteers receive a placebo and which receive the active treatment. This allows the doctor and research staff to observe the volunteers during the study without any potential bias.
Regardless of which treatment volunteers receive, the level of medical attention and care provided is the same.
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What questions should I ask before choosing to participate?
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Talk with your doctor or other medical provider before deciding whether to participate. Asking these questions can help you make an informed decision together:
- How long will the trial last?
- Where is the trial being conducted?
- What treatments will be used and how?
- What is the main purpose of the trial?
- How will patient safety be monitored?
- Are there any risks involved?
- What are the possible benefits?
- What are the alternative treatments besides the one being tested in the trial?
- Who is sponsoring the trial?
- Do I have to pay for any part of the trial?
- What happens if I am harmed by the trial?
- Can I opt to remain on this treatment, even after termination of the trial?
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What can a patient in a trial expect?
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Participants often receive a physical examination and have their medical histories reviewed by either the study doctor or a research staff member once they are enrolled in the study. Their health will continue to be monitored during and after the trial. A detailed description of what’s expected of volunteers will be outlined in consent forms, along with specific clinical trial information.
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Are trials confidential and private?
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Access to personal information is usually available to the investigator and research team conducting the clinical trial. In some circumstances, the Institutional Review Board overseeing the research and the sponsor or contract research organization coordinating the trial will also have access to personal information.
This is explained in more detail in the consent form that participating volunteers are asked to sign. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals and to various government agencies.
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What happens after the clinical trial?
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After a study phase is complete, data is collected to determine the treatment’s effectiveness, if it’s safe and if there are any side effects. Depending on the results, researchers then determine whether to stop testing or move to the next phase of study.
After phase III of a study is complete, researchers decide if the results are medically important and may submit them to journals for peer review. Data then may be submitted to the Food and Drug Administration (FDA) for approval.
If a drug is approved by the FDA, pharmaceutical companies may continue to conduct studies that compare the new medication — in terms of its safety, effectiveness and cost — to other medications already on the market, or assess its long-term effectiveness and impact on quality of life.