All clinical trials are conducted in a rigidly consistent way, so that each patient is treated exactly the same as all the other patients in the study. This way they can reduce, as much as possible, any variables that would confuse the anticipated outcomes. You will receive the exact same treatment, according to the exact same schedule, and your check ups and follow up appointments will record the exact same types of information. Regardless of where you are treated – in a small hospital or a big cancer treatment center – the clinical trials doctors whose patients are accepted into the study are responsible for a strict adherence to protocols and reporting standards. These doctors in small communities and rural settings make it possible to treat patients in their own home towns, offering these newer treatments to a larger study population. If you participate in a clinical trial, you will either be given a standard treatment (because you will be in the control group), or you will be in the study group and given the new treatment. In most cases you — and not even the doctor — will know which group you are in.
The trial team is required to clearly explain all and any potential risks and inconveniences to you, even minor ones. When applicable, you will also be told about alternative, recognized medical therapies available. In addition, investigators must make you aware of any information that becomes available during the trial that may be relevant to you. You will be asked to sign a consent form clearly explaining that your participation in the trial is voluntary. And you will be given the name and contact information for the trial’s main investigator and a person from the Ethics Committee.
Clinical studies are conducted in four phases. If you are told it is a Phase I study, this means there will be a relatively small number of volunteers (maybe as few as 20) and the study will be used to determine the best dosage, or the best delivery method (oral, IV, etc.), or how often it should be given. These studies monitor the safety and the side effects of the new drug, dosage, or method, or schedule. If the study you are offered is a Phase II study, this means that there will be a larger number of volunteers (say, 100+). In these studies, they are continuing to carefully monitor the safety and side effects of the best dosage, delivery method, and schedule for a treatment studied in a Phase I trial. If you are told it is a Phase III trial, you will be part of a study that includes many patient volunteers (say 1,000+). These are the studies that determine if the new treatment or combination of treatments is safer and/or has less harmful after effects or side effects than the standard treatment(s) for the same cancer. At the end of the Phase III trials, the treatment may be approved for use on all patients. Phase IV studies continue to monitor the treatment for its long- term safety and efficacy. Often Phase IV studies test the new treatment in specific populations such as male vs. female, patients between the ages of 20-40 vs. 40-55 vs 50-70, etc.
Are there risks to participating in clinical trials? The answer here is the same for all cancer treatments. Almost every type of cancer treatment has known side effects and potential long-term harmful adverse effects. So, it is important to talk with your medical team about the relative risks you may face with every treatment option you are considering, and weigh the possible risks and benefits of the treatment options. Ask yourself what you want out of the treatment. Then discuss your personal expectations regarding opting for the clinical trial with your oncologist and with the doctor who will be treating you in the clinical trial, and ask the doctors if they believe it is a worthwhile alternative. Consult your insurance coverage to determine if your benefits include clinical trials. The bottom line is this: Clinical trials present many potential benefits that may outweigh the potential risks, when compared with other treatment options. Become as informed as you can about the option of participating in a research study that may help you, and may help other cancer patients as well.
You can review an excellent overview of a clinical trial “journey” and timeline on www.clinicaltrialsandme.com. It explains in detail what you may expect as a clinical trials participant.
Lastly, here are the important questions you will want to ask of the doctors conducting the clinical trial:
- Who are the doctors and nurses who will oversee my medical care during the clinical trial, and when do they begin overseeing my care and will I go back to my own oncologist after the trial is over?
- How long will the clinical trial run? Under what circumstances will the trial be shortened or cancelled?
- Who decides which treatment I will receive?
- How do the expected side effects differ between the two groups?
- Who will pay for my participation? If my insurance doesn’t pay, does the cancer center where I am going to be treated have any assistance programs for this clinical trial?
- Will I need to be in the hospital for these treatments? How long? How do I prepare for the day of treatment? What can I expect in the next few days after treatment?
- If this is a Phase III or IV study, what adverse reactions were experienced by other patients in the earlier studies of this treatment?
- If I feel I must withdraw from the study, what happens then?
- If the trial is successful, will I still be able to get it after the trial ends?