Even if there is no clinical trial in the area in which you live, you may not have to leave home or see a new doctor to participate in a clinical trial.

Many local hospitals are affiliated with clinical trials through the Community Clinical Oncology Program (CCOP) of the National Cancer Institute. This allows you to participate in a clinical trial while staying closer to home. 

Even if there is no local way to participate in a clinical trial, most trials minimize the amount of travel. They also allow your own cancer doctor to handle most of the care. Some even provide travel expenses for people who participate in their trial.

Clinical trials are sponsored by:

• Government agencies such as the National Institutes of Health (NIH)
• companies
• Research scientists
• Individual physician-investigators
• Health care inPharmaceuticalstitutions
• Organizations that develop medical devices or equipment

You should be told if the doctor running the study has a financial interest in the outcome. If you’re not told – ask.

Consider the type of the doctor’s interest. For example, if the doctor is the inventor of the drug or device being tested, it is not unusual that the person may have an ownership interest in the company producing the drug or device, or receive a royalty.

A financial interest could cloud a person’s judgment, but it doesn’t mean that you shouldn’t participate in the trial. The financial interest becomes one more factor to consider when deciding whether to join.

Trials can take place all over the country (and the world) in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.

All clinical trials have guidelines about who is allowed to participate in the program. Guidelines are based on such factors as age, type of disease, medical history (including treatments you may or may not have used), and current medical condition. Before you join a trial, you must qualify for the study. Inclusion and exclusion criteria are used to identify the appropriate participants and to protect their safety. The criteria also help to improve the odds that researchers will be able to determine the answers to the questions they plan to study. The criteria are not used as a personal rejection for those individuals wishing to participate in a trial.

"Inclusion Criteria" is the term used to describe people who may participate in a particular trial. For example, a trial may only be looking for people that have been diagnosed with Stage IV breast cancer.

"Exclusion Criteria" is the term used to describe people who may not participate in a particular trial. For example, a person with an HIV diagnosis may not be eligible for a particular trial if she is currently taking, or did take, a specified anti-viral medication.

The phase of a trial may have a direct bearing on the possible benefits and risks of a study.

The benefits may include:

• Taking an active role in your own health care.
• Gaining early access to new treatments that are not yet available to the public.
• Obtaining expert medical care and treatment at some of the nation's leading healthcare facilities during the trial.
• An accessible, informal expert source to answer questions about your condition.
• Meeting other people with your condition with whom you can trade practical tips and local information.
• Helping others with your condition by contributing to much needed medical research.

Possible risks may include:

• Side effects or adverse reactions to medication or treatments.
• The treatment may not be effective for you which means you have not spent the time taking a treatment which may be effective. Your condition may worsen as a result.
• The treatment protocol may require a lot of your time and commitment for trips to the study site, treatments, hospital stays, or complex dosage requirements.
• There may be some out-of-pocket costs associated with a trial, ranging from uncovered testing, to travel and child-care expenses.

The drug may work, but it may not be available once the trial ends. There are no government rules mandating that someone who is doing well on an experimental medicine must keep getting it.

You should continue to see your specialist and primary care physician while enrolled in a clinical trial.  Your doctor:

• Can help ensure that other medications and treatments do not conflict with the drug being tested in the clinical trial.
• May help identify any adverse reactions or side effects you may experience from the experimental drug.
• Be on guard against signs of a medical condition not related to the condition which is the subject of the clinical trial.
• Both doctors, but particularly your primary care physician, will see you over the long haul. Most clinical trials are designed to only provide short-term treatments. Even those trials providing longer term treatment are not usually designed to provide complete primary health care.

It is advisable to discuss the matter with your doctors before starting a clinical trial. Your doctors can explain the real risks and benefits and provide an expert opinion about whether the trial is worthwhile for you.

At least one of your doctors will also likely have to submit additional paperwork because of your participation in the trial. What the doctor says in the paperwork could help assure, or hinder, insurance company reimbursement.

You should continue to see your specialist and primary care physician while enrolled in a clinical trial. 

Your doctor:

• Can help ensure that other medications and treatments do not conflict with the drug being tested in the clinical trial.
• May help identify any adverse reactions or side effects you may experience from the experimental drug.
• Be on guard against signs of a medical condition not related to the condition which is the subject of the clinical trial.
• Both doctors, but particularly your primary care physician, will see you over the long haul. Most clinical trials are designed to only provide short-term treatments. Even those trials providing longer term treatment are not usually designed to provide complete primary health care.

It is advisable to discuss the matter with your doctors before starting a clinical trial. Your doctors can explain the real risks and benefits and provide an expert opinion about whether the trial is worthwhile for you.

At least one of your doctors will also likely have to submit additional paperwork because of your participation in the trial. What the doctor says in the paperwork could help assure, or hinder, insurance company reimbursement.

Yes - at any time.  The decision whether to leave is totally yours.  If you do plan to stop participating, inform the research team and explain why you are leaving the study. Your reasons for leaving a study can provide the research team with valuable information.

Being a part of a clinical trial, or even considering one, can raise all sorts of emotions -- including the feeling of being a "guinea pig." As you see elsewhere in this article, safeguards are built into all clinical trials to protect your medical and psychological health.

Fear of the unknown can be unsettling. Understanding what is involved can ease some of your anxieties.

If the emotions become overwhelming, seek help from your doctor, a support group or a professional therapist.

You are free to seek medical treatment anywhere in the world you want. However, do not expect your U.S. based health insurance to pay for it.

If the clinical trial is being conducted in a medically advanced country, under the sponsorship of a reputable institution or company, and the medical necessity seems clear -- it may be worth taking a shot at getting your insurer to pay at least some of the costs yo would otherwise have to pay.