Northwest Hospital & Medical Center supports medical research by physicians on its medical staff and encourages patients to find out about clinical studies and trials available to them. If you are interested in participating in research about your disease or condition, we recommend you speak with your doctor.

You may be interested in learning more about clinical trials. Here is a brief overview of the clinical trial process, with a look at key questions and terms.

Clinical trials, or research studies, utilize patient volunteers to help investigate different ways to treat diseases. Clinical trials involve the use of investigational drugs (also known as study drugs), drug delivery methods or other diagnostic or therapy methods. Each study tries to answer specific scientific questions about different ways to prevent, diagnose and treat whatever disease it is addressing.

Clinical trials contribute to the overall knowledge and progress made in developing therapies for diseases. These research studies are conducted to determine if a study drug, delivery method or therapy is safe and effective. Patients who agree to participate may possibly benefit from the research study, while receiving the best current standard treatment as well.

Clinical trials are structured into four phases:

      In

Phase I clinical trials

      , researchers test a study drug in a small group of people (20 to 80) for the first time to evaluate its safety, determine a safe dosage range and identify side effects.
      In

Phase II clinical trials

      , the study drug is tested in a larger group of people (100 to 300) to measure its effectiveness and further evaluate its safety.
      In

Phase III clinical trials

      , the study drug is tested in large groups of people (1,000 to 3,000) to confirm its effectiveness, monitor side effects, compare it to approved standard treatments and collect information that will allow the study drug to be used safely.
      In

Phase IV clinical trials

      , the drug is tested after it has been marketed to collect information about its effect in various populations and about any side effects associated with long-term use.

In many trials, if the patient is eligible and agrees to participate by signing an Informed Consent, the patient is randomized (by chance, like a coin toss) to either receive the current standard treatment or the current standard treatment and the study drug regimen. If no standard treatment is available, a trial may compare the study drug to a placebo, which is similar to the study drug, but contains no active ingredient. During a trial, patients are treated and monitored by a team of health care professionals. This team will give the patient specific instructions about the trial, about more tests and additional doctor’s visits that might be required.

Throughout the clinical trial, you come first. If there is no improvement or you experience intolerable side effects, you and your physician can decide to discontinue trial participation and resume other treatment options. Should you do so, your decision will be respected without any effect on future treatment plans.

Some patients may participate because they are hoping for a possible cure and longer life or a way to feel better. Others find that the current standard therapies are not optimal for their disease and wish to be among the first to participate in a research study and receive an investigational drug. Whatever the reason, participation could make a difference in a patient’s future, as well as in the lives of future patients.

Because clinical trials are research studies, study drugs may be no better than current standard drugs or treatments. In addition, you may experience side effects that are worse than those of current standard drugs and treatments. Also, your health insurance company may not cover all of the costs associated with a clinical trial. All of these factors should be discussed thoroughly with your physician and those close to you before deciding whether or not to participate in a clinical trial.

If it is a medical emergency please call 911. The decision to participate in a clinical trial is one that only you can make, with the help of your physician and the people close to you. If you are interested in participating in a clinical trial, first it must be determined if you are eligible and meet the criteria for the study. You will also be informed of the clinical trial’s potential benefits and drawbacks before making your decision. If the investigational drug is proven to be effective, you may be among the first to benefit. In addition, through your participation in a research study, you will also be helping future patients
Information courtesy of USOncology