You should try to get as much help and information as you can to make a decision but, ultimately, the decision is yours. Donít let anyone make you feel pressured to participate, or not to participate, in a clinical trial.
Don’t Be Afraid of Clinical Trials: They Could Improve the Quality of Care You Receive
If you are like most people, you have probably heard the term clinical trial before, but don’t know exactly what one is or how one works. Unfortunately, there is a general misconception among the public that a clinical trial is simply an experiment, which frightens most people. This is unfortunate because, for some people, clinical trials can offer better treatment than they would receive in conventional care.
Because cancer is such a serious illness, clinical trials for people with cancer can seem especially scary. You may think that, instead of considering something new, you should be doing everything you can to make use of the best possible existing medicines and treatments to get better. Yet, in many cases, the best treatment you can receive is probably being improved right now, through a clinical trial.
Why Clinical Trials?
Cancer is a complicated disease – there are more than 100 different types and a wide variety of ways they can affect the body. Because of this, doctors are continually trying to improve how cancer is treated. Cancer treatment relies heavily on researching new surgical procedures and new chemotherapy, radiation therapy, and hormonal therapy methods in an effort to make these treatments more effective and thorough. This is why there are, at any given time, a large number of clinical trials taking place that are designed for people with cancer.
A clinical trial is, quite simply, a research study designed to evaluate a new treatment. However, it is important to remember that, in most cases, the new treatment being tested has already shown promise of being an improvement over the current therapy. It is not just an unregulated experiment. In fact, many clinical trials are tests to see how much better a new treatment works than the current therapy. People in clinical trials are among the first to receive new treatments, and are closely monitored by physicians and other researchers involved in the trial.
Clinical trials are usually set up in the following way: Patients are randomly assigned to either a conventional or experimental treatment group; the conventional treatment group receives the best current therapy, while patients in the experimental treatment group receive a new treatment. What is new about the treatment can mean any number of things, depending on how the trial is designed – new drugs, new dosages, new combinations or procedures, even a new way of administering a drug.
Yet, despite the fact that clinical trials continue to play a key role in the progress against cancer, only three to five percent of all adult cancer patients take part in a clinical trial. The considerations below will, we hope, help you determine whether a clinical trial is right for you.I. Medical Considerations
The first thing you will need to know is whether there is a clinical trial available for someone with your type and stage of cancer. The best place to start for this information is your doctor or oncologist.
The next thing you need to find out about a clinical trial is whether or not you are eligible for the one you are considering. This will depend on many things, some of which may have nothing to do with your illness, for instance: your insurance status, whether you have had other treatments in the past, or even where you live or how old you are. However, it is important not to become overly enthusiastic if you do qualify (which can often lead to people believing they are going to be cured) or depressed if you do not qualify (which can lead people to think there is no hope). Neither conclusion is true.
If you do find a clinical trial that is right for your specific type of cancer that you are eligible for, the next step is for you to understand what specific treatment is being offered and how it differs from the standard treatment available for your cancer. There are many ways to do this, but an important step is to obtain a copy of the informed consent statement of the trial. This statement is a complete description of the trial. The law requires that you are given a copy of this statement, and it will be provided to you by the clinic or hospital running the study. Often, whoever is conducting the trial will give you an explanation of the trial either in person or over the phone, because informed consent statements are very detailed and can be somewhat hard to understand.
Finally, you should find out how the new treatment is expected to affect you as a patient. This will mean understanding new or possibly unique side effects of the new treatment. You should discuss these with your health care team ahead of time. Also, try to judge if it will limit you in ways that conventional treatment would not, and how these limitations will affect your quality of life. You should also talk about pain and pain control throughout the duration of the treatment. These are the most common medical considerations that you should know when trying to decide whether to take part in a clinical trial.
II. Practical Considerations
Unfortunately, people with cancer have many practical issues they must also consider when deciding whether to join a clinical trial. Discussing these issues ahead of time can do much to help you feel less anxious and make you and your family more prepared for it.
First, you will want to know about the costs involved in the trial. Unfortunately, most health plans do not include coverage for experimental treatment along with associated physician and hospital expenses. While your project sponsor will almost surely cover the cost of any new drugs used in the trial, you may need to advocate for reimbursement from your insurer for coverage for the other costs associated with the trial. This can be stressful and time-consuming, with no guarantee of a decision in your favor.
You may also want to know whether your participation in the trial will involve traveling to another medical facility, city, or state. Out-of-pocket costs such as travel, hotels, meals, and parking can add up and be very expensive. You should also ask about the expected duration of the treatment and what time commitment you will be required to give.
Lastly, most people want to know whether their family members can accompany them to treatment. In general, it is advisable to include your family caregivers in both decision-making and helping you take part in the clinical trial. Throughout any form of cancer treatment, support and encouragement are always important.
III. Emotional Considerations
Clinical trials also bring up many emotional issues. Again, your first reaction to the idea of a clinical trial may be that of fear; you may be concerned about becoming a guinea pig. You should know that, by law, all clinical trials have safeguards to protect the medical and psychological health of the participants. In addition, all trials are subject to peer review by the institution that runs them, the trial’s study sponsor, and the scientific community. And you have the right to drop out of any clinical trial at any time – no one can force medical treatment on you. This is important to remember.
Another consideration is that entering into a clinical trial will sometimes require changing your physician or dealing with a large health care team instead of just one doctor. You will probably want to know this beforehand and prepare for the change. You should also ask about the impact your involvement will have on your loved ones, as well as on your work situation.
Clinical trials can offer many advantages to people undergoing cancer treatment. The most common is that there is a chance that the new treatment will improve your health and prognosis. Also, you will receive extensive monitoring, close follow-up attention during the trial, and perhaps better medical and psychosocial care than people getting conventional treatment will.
However, there may be disadvantages to your participation in a clinical trial, even if they are not medical in nature. For instance, you may feel more like a research subject than an individual, and you may have to invest more time in a trial than in a conventional treatment. Another possible drawback is insurance reimbursement; you may encounter problems with exclusion or denial of coverage, both of which are common.