This is a common concern among patients when they consider participating in clinical trials. Patients are concerned that they will not know what is going on and will be at the mercy of the researchers. Fortunately, this not true. Because of the “Informed Consent” process, you will be made fully aware of what will happen during the trial and know what to expect. Even if changes occur during the trial, you will be informed of those changes as well. You will receive excellent care because of the extra attention by your doctor and research team to make sure your health is not being negatively affected in any way. Your health and well-being is always a top priority.
Every clinical trial has a set of guidelines that determine what characteristics a participant must have in order to participate known as Eligibility Criteria. This determines who can participate in a trial and who cannot. Your doctor will go over the criteria to make sure the trial is a good fit for you based on your health history.
Hawaii Cancer Care and Innovation Clinical Research of the Pacific welcomes all patients who are considering joining a cancer clinical trial. You do not have to be a current patient with Hawaii Cancer Care. Our care team will help you with the transition process. If you do not live in Hawaii and need assistance to find housing to receive treatment, our care team can assist you with this as well.
Before any clinical trial begins, there were many of years of research in a lab to develop and understand the effects of the new treatment on cancer cells. Researchers are looking to see how cancer cells (in a dish) or animals with cancer respond to the new treatment. However, even with all the testing and information being collected in the lab, the drug or treatment may perform or react differently in humans. For instance, a cancer treatment showed promise in mice may not have the same results in people. Before clinical trials can begin, The US Food and Drug Administration (FDA) must grant permission for its use.
Every clinical trial has a medical doctor, also known as the principal investigator, who is in charge and the lead researcher of the trial. The principal investigator also prepares an action plan for the trial known as the protocol. The principal investigator works with a research team of other doctors, nurses, and other health professionals to make sure the protocol is being followed and the trial is running smoothly.
It is a myth that clinical trials are only for people with advanced stages of cancer with no other options for treatment. There are trials available for all stages of cancer and is should always be considered if you or a loved one needs cancer treatment. Many newly diagnosed cancer patients choose to participate in clinical trials as their first cancer treatment.
There are other types of cancer clinical trials and they don’t always just involve testing drugs. There are trials available for cancer patients, cancer survivors, or those who are at high risk for developing cancer. Clinical trials should always be considered as a treatment option.
Placebos, or “sugar pills” are pills that have no effect on the patient if it is given to them. Cancer clinical trial participants are almost never given a placebo if there is a treatment option available. Usually a placebo is used in conjunction with the standard treatment to compare it to the new treatment(combined with the standard treatment) being studied, or if there is no standard treatment available. If it is possible a placebo will be used in a trial, the doctor will let you know during the informed consent process.
You can leave a study at any time for any reason. You can discuss other treatment options available to you with your doctor and still expect to receive a high level of care.
Several of our doctors at Hawaii Cancer Care are Principal Investigators, or lead doctors for Innovation Clinical Research of the Pacific for cancer clinical trials who will oversee and work closely with you. You may still be able to visit with your regular doctor while you are participating in a cancer clinical trial if you are currently a patient of Hawaii Cancer Care.
Our clinical trials take place at Hawaii Cancer Care clinics, so traveling to the mainland is not necessary. If there is not a trial available for you through Innovation Clinical Research, your doctor can help you find one here in Hawaii. It is important to be home with family and friends close by while you are on your journey to healing.
A clinical trial can change or end while you are participating for different reasons. The doctors or IRB may stop a trial because they are finding participants are experiencing serious or harmful side effects. It can also end if researchers are finding results that are better than expected and would like to submit the drug or treatment for approval to the FDA (Food and Drug Administration) for release as a new standard treatment. Patients affected by any trial stoppage will be offered additional treatment options.