Clinical trials are research studies that are designed to evaluate experimental (or “investigational”) medical treatments or procedures. Our clinical trials are designed to evaluate experimental treatments and procedures for cancer patients. Clinical trials play a key role in the progress against cancer at Saint John’s Cancer Institute and other institutions.
The search for new cancer treatments or diagnostic tests begins in the laboratory. Experimental drugs, agents, or procedures are tested on cells or animals. If laboratory and animal testing demonstrates effectiveness with cancer cells or tumors and is safe, a clinical trial may be designed to evaluate if similar results occur in human beings. A clinical trial is just one stage in the long and detailed cancer research process.
Clinical trials can be designed to evaluate modifications to existing or “standard” treatment for specific cancers, new experimental drugs or agents, new experimental ways to care for people with cancer as they receive treatment, or experimental methods of identifying cancer.
Most advances in the diagnosis, treatment, and care of patients with cancer have occurred because of clinical trials. Examples include improved diagnostic tests that allow for earlier treatment, increased knowledge and education regarding risk factors, and experimental treatments (e.g., surgery, radiation therapy, chemotherapy or biological therapy). The results of many clinical trials have contributed to healthcare professionals finding better ways to treat cancer.
There are many reasons why you may choose to volunteer for a clinical trial. First, there is a chance that an experimental treatment will be more effective than “standard” treatment for a specific disease, though it could also be less effective. Second, patients often receive more detailed follow-up care from doctors and health care professionals, who often specialize in the disease (e.g., cancer). Third, patients may want to help scientists and health care professionals learn more about the experimental treatment or test being studied so that others may benefit in the future.
In the past, clinical trials were sometimes seen as a last resort for cancer patients who either had no treatment choices or had exhausted them. Today, many cancer patients choose to volunteer for a clinical trial in order to receive some sort of experimental treatment as their first treatment attempt or as an adjunct to their first treatment attempt.
Whether you’re a cancer patient, cancer survivor or at risk for cancer, clinical trials offer you more options. In all cases, participation in a clinical trial is completely voluntary. It is your decision. You may decide to stop participation at any time during the clinical trial. Choosing not to participate in or withdraw from a clinical trial will not affect your ability to receive regular treatment.
Only you and your doctor can decide if a clinical trial is best for you, but we encourage all patients to ask their doctors if a trial is available and appropriate for them.
Clinical trials are designed using experimental standardized plans, which sometimes can be very complex. These standardized plans, called “protocols,” are developed as part of every clinical trial and provide a framework for the objective collection and analysis of data, and the protection of study volunteers. The development of clinical trial protocols is initially based on laboratory and animal research, and sometimes on other clinical trials involving human beings. In the case of an experimental treatment for a disease, the protocol would identify exactly what procedures would be followed to determine effectiveness against a specific disease and any side effects that occur. Oncologists and oncology nurses (doctors and nurses specializing in cancer, respectively) follow the protocols in order to accurately collect data for research.
Before a clinical trial can begin, a scientific and ethical review board, called an Institutional Review Board (IRB), evaluates the proposed clinical trial protocol to determine whether it is safe, scientifically sound, and appropriately designed, and also to ensure that patients are appropriately protected. This board is made up of healthcare professionals, administrators, and laypersons. All clinical trials using drugs, devices, or procedures not yet licensed by the FDA must receive the approval of the appropriate IRB before any patients are allowed to volunteer for participation.
All clinical trials of investigational agents are divided into four categories: Phase I, Phase II, Phase III, and Phase IV. All experimental cancer treatments must go through the first three phases before being submitted to the FDA.
- In Phase I, researchers determine the safe dose of the experimental agent and learn about its side effects. Patients with many different types of cancer may be asked to take part in a Phase I trial. Patients are usually divided into distinct groups. Each group is given different doses of the experimental agent so that safe doses can be found, most importantly, the highest dose of the drug that can be given safely to human beings.
- In Phase II, researchers test the effectiveness of the experimental agent in stopping or controlling the growth of tumor cells for a specific type of cancer.
- In Phase III, researchers determine how the experimental agent compares with standard treatment in the management of tumors. To gather as much information as possible, Phase III trials usually involve many more patients than the previous phases and often are performed simultaneously at many cancer research centers.
- In Phase IV, researchers study drugs and/or treatments that have already received FDA approval. The goal of Phase IV trials is to study how safe and effective a drug or procedure is over time.
All patients taking part in a clinical trial are followed carefully by their doctor and nurse. Physical examinations, blood tests, and x-ray examinations all may be part of your evaluation before, during, and after each trial. These examinations and tests are done to determine whether you are an appropriate volunteer for a clinical trial, to measure the effectiveness of the experimental agent, and to help detect side effects as early as possible.
Your role in a clinical trial may alter or cease for a variety of reasons. Some clinical trials stop after a predetermined length of time. If your disease changes for the better or worse, or if side effects become too severe, it may be determined that it would be better for you to stop or alter your dose. If you or your doctor feel at any time that a clinical trial is no longer your best option, or it is felt that another treatment would be more beneficial, you may stop. If your participation in a clinical trial is stopped for whatever reason, you still may be evaluated to see if an approved or standard treatment is available, or if another clinical trial would be an appropriate option.
At the initial study visit you will be asked to review an informed consent form which will go into detail on the study medication, risks/benefits, potential side effects, alternatives to participation, your rights during the study, as well as any potential compensation that may be offered. Although it is not possible for us to list all procedures that will occur during the first visit because of differences in study protocols, the first visit typically entails a full medical/surgical history, vital signs, physical exam, labs, and an EKG.
Each research study is different. Some studies are only a few weeks long while others can last up to 1 year or longer.
You can stop participating in a research study at any time and for any reason. We do ask, however, that you let our site know about your decision so that we can understand the reasons and perform an early termination visit for final safety examinations and tests.
Depending on the study you may be compensated for reasonable expenses including time, travel, parking and accommodations as applicable. A member of our study staff will discuss the study medication, risks/benefits, potential side effects, alternatives to participation, your rights during the study, as well as any potential compensation that may be offered.
After you fill out our form, a member of our study staff will contact you to get information about your medical history. We will save your information in our database and will contact you once we get a study that would be a good fit. You are also encouraged to reach out to us periodically to see what new studies we may have coming up.
How do clinical trials help patients and future patients?
Stage 4 Cancer Survivor, Jay Fukazama, provides his accounts with voice narration.