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Clinical trials are research studies that test whether new or existing treatments work better and are safer than current treatments. People who volunteer for clinical trials play an active role in their own health care, gain access to new research treatments, and help others by contributing to the advancement of medical research.
At Providence, our physicians ensure clinical trials are part of regular cancer care. Our clinical trials include studies sponsored by the National Cancer Institute and pharmaceutical companies.
Clinical trials for cancer test the effects of treatments, such as surgery, radiation therapy, chemotherapy, biological therapy and targeted therapy after biological therapy.
They also measure different ways of improving quality of life for patients. Most advances in the fight against cancer come from knowledge gained through clinical trials.
It can take researchers more than 10 years to develop a new medicine. It takes this long because each new medicine is thoroughly tested for safety and effectiveness.
As new medicines are discovered, they pass through three stages of research: Phase I, II, and III. If it successfully passes through all three phases, a medicine is submitted to federal authorities who must approve it before the general public can use it.
Preclinical: Studies conducted with animals or in the Laboratory.
Phase I: The first to occur in humans (cohort of 15-30 patients). Te goal of this phase is to find out if the dose used for treatment is safe.
Phase II: Consisting of fewer than 100 patients, the goal here is to assess treatment efficacy and adverse events.
Phase III: This phase includes thousands of patients throughout many research centers. These trials determine whether the investigational treatment is better than the current or standard treatment. After this phase is complete, the FDA reviews the trial data and determines approval.
Phase IV: Clinicians study treatments the FDA has already approved. The goal here is to continue to assess side effects associated with a particular treatment.
People volunteer for clinical trials for many reasons. Through trials, they have the chance to:
Participating in a clinical trial may involve risks and discomforts. However, participant safety is the top priority in every stage of the process.
Before someone can join a trial, he or she talks with the clinical trial coordinator to learn about the trial and ask questions. They sign an informed consent document to show they understand and agree to what the trial involves.
A team of doctors and nurses closely monitor the patient's health as long as the patient is involved in the trial.
Every clinical study is unique. One may last a couple of weeks; another many last a couple of years. Not all studies involve taking medicine or making changes to current treatments. Participants are often asked to visit several times to have their health monitored.