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 healthcare, gain access to new research treatments, and help others by contributing to the advancement of medical research.
At Providence Cancer System, 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.
What are the goals of clinical trials?
- Answer specific questions
- Find better ways to prevent, diagnose or treat disease
- Discover whether a particular medicine or treatment is safe and effective
- Learn how to improve quality of life for patients
- Discover a more effective, safer way to administer a treatment or medicine
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.
What kind of clinical trials are there?
- 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.
Why participate in a clinical trial?
People volunteer for clinical trials for many reasons. Through trials, they have the chance to:
- Receive a new medicine before it's available to the general public.
- Help researchers develop new treatments that many benefit themselves or other patients in the future.
- Have their health closely monitored.
- Gain access to doctors who specialize in treating their condition.
How are participants protected?
Participating in a clinical trial may involve risks and discomforts. However, participant safety is the No. 1 priority in every stage of the process.
Before the trial
Every clinical trial at Providence Regional Cancer System must be reviewed by the Investigational Research Studies, Oncology, Coordinating Committee (IRSOCC). This committee is comprised of physicians, oncologists, nurses, ethicists, pharmacists and many other relevant experts. Every clinical trial must additionally be reviewed by an appropriate Investigational Review Board (IRB). These board consist of physicians, nurses, ethicists, pharmacists and local lay people.
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.
During the trial
A team of doctors and nurses closely monitor the patient's health as long as the patient is involved in the trial.
What can participants expect during a 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 their cancer center several times to have their health monitored.