Clinical Trials

Most cancer patients will be confronted with the decision to participate in a clinical trial or not. Clinical trials are vital to the advancement of medical sciences. Researchers recruit participants for their trials. Dosages for drugs are determined. Dose limiting toxicities are observed. Side effects and complications are determined.

However, as a patient who has participated in a clinical trial and who is considering whether or not to participate in another clinical trial, I would highly recommend considering several factors first before signing the consent form.

Most importantly, you need to be aware of the risks, benefits, and specific details of the treatment being proposed to you in the context of the clinical trial. Be certain to ask about all treatment options that are available to you. I always want to know what additional testing will be required of me in order to be a trial participant. Also, since I take many medications, I want to know if the eligibility criteria for the clinical trial will allow for me to continue on current medications and supplements.

It is worth asking if you are allowed to speak to currently enrolled trial participants. If that option is not available to you, most all trials have a clinical research nurse to whom you can direct your specific concerns and questions about the research associated with the clinical trial.

Be certain that you know how your insurance company will respond to your participation in a clinical trial. While several states have passed legislature that requires insurance companies to pay for routine care associated with participation in a clinical trial, many states remain without such laws. Visit this website to learn more about your state's laws regarding insurance and clinical trials: http://www.cancer.org/docroot/ETO/content/ETO_6_2x_State_Laws_Regarding_Clinical_Trials.asp

Most participants will want to know what phase of research does the trial represent? My personality tends to be conservative by nature. A Phase IV would be more comfortable than a Phase I trial for me to consider. Clinical trials are often described by "phase". According to the NCI, phases of clinical trials are:

Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.

Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.

Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.

In addition, after a treatment has been approved and is being marketed, the drug's maker may study it further in a phase IV trial. The purpose of phase IV trials is to evaluate the side effects, risks, and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials. Thousands of people are involved in a phase IV trial.

Many financial concerns and questions must be answered for clinical trial participants. Will you be compensated for your participation? Many clinical trial sponsors do not reimburse participants for their participation, time, travel, and other costs. Some clinical trial sponsors have small reimbursements available for participants. These are all questions and concerns most participants need to consider (unless you are very wealthy and money is not an issue).

I had the opportunity to be a clinical trial participant at the National Cancer Institute (NCI) in Bethesda, Maryland. The NCI is part of the National Institutes of Health (NIH), one of our nation's premier sponsors of medical research. At the NCI, after I made my first trip and enrolled in the clinical trial, my travel expenses were covered by the NIH. Airfare, a food per diam allowance, lodging, and the cost of ALL care provided at the NCI were free of charge. I must admit the NIH is one of the most exceptional uses of government funds that I have ever witnessed.

If your personal physician has not recommended a specific clinical trial, yet you are interested in this approach to treatment, you might wonder how to locate clinical trials available to you? The NCI's website, http://www.cancer.gov/ is an exceptional resource for locating clinical trials for cancer patients. On their search engine you can specify if you want information on trials only at the NIH Clinical Center in Bethesda, or if you want to review clinical trials at other facilities around the country.

From a patient's perspective, I will offer some reflections about my participation in a clinical trial. Although my travel expenses were paid for by the clinical trial center, I quickly learned that the amount of travel involved was tiring. Being away from my family came with a price as well. I became very ill at one point while enrolled in the clinical trial. I was almost 700 miles from my family and ended up in an Intensive Care Unit. At that moment in time, all I wanted was to have my family nearby.

Obviously, when enrolled in most clinical trials, as a participant, you will be separated from your familiar medical team. Participants need to be willing to adjust and adapt to new people, new environments, and new approaches to their care and treatment. Sometimes the care in a clinical trial tends to be a bit impersonal. On the other hand, some research centers are quite skilled at coordinating the many details of complicated cases in a personable fashion.

There is a deep sense of personal satisfaction knowing that you have done something to contribute to finding a cure or a better treatment for the disease you are battling. This was one of my greatest revelations regarding clinical trial participation. I have also donated tissue, blood, and DNA for research purposes. By participating, to whatever degree, in medical research, most patients will discover that they are empowered and energized by doing their part for science.