Saturday, July 9, 2011

Should I Try a Clinical Trial?

In order to see if a medication or a treatment will work, prevent a disease or even eliminate side effects of existing treatments, researchers test it out. There are different types of clinical trials, but the focus of this post is to help you decide whether to do a study where a new treatment (medication, surgical or other type of intervention) for your condition is being studied.

The pluses of participating in such a clinical trial include:
• It could result in a cure and/or improve how you feel and function
• You will be helping others
• You may get more medical attention while you are in the study
• Medical care costs and the experimental treatment will often be covered
• You may have access to treatment that would not otherwise be available.
• It may expand your treatment options
• You may feel you have more control over your situation by taking such an active role

The downsides, or risks, are quite real. These may include:
• Side effects can be serious and could even make you feel worse than you already do.
• If this is a placebo controlled study, or one trying several different regiments, you may not receive the experimental regiment
• It may require travel, and time (such as more doctor and lab visits) that could not only be inconvenient but could also be wearing on you.
• Insurers may not cover all of the costs of taking part in a clinical trial, but they should pay for normal or standard care.

Before deciding whether a particular clinical trial is one you want to participate in, you will need to meet the study requirements. These will be quite specific, including such things as your age, gender, diagnosis, prior treatment etc.

Sometimes providers will suggest studies to patients, other times, people will learn about them from support groups or looking on-line. To find out about clinical trails that you may qualify for, talk to your medical provider, check your medical center’s website, and check Clinical

If you qualify for a study, consider the questions below. To help you in the decision making process, rate each question with a plus –a good reason to participate-or a minus-a reason not to participate. When you finish, add up the pluses and minuses and see which seems to be the best option for you.

• Who is conducting the research?
• What is its purpose? What are the potential short and long term benefits?
• What has your doctor told said about your condition and what the future holds? Could your participation impact this?
• Has the treatment been tested before? If yes, what did the research show?
• How are trial results and patient safety being checked?
• Is there a research site close to where you live? Would you have to travel? Is so, would this present a problem?
• Would you have to change providers to be part of the clinical trial? Who would be in charge of your care? Your long-term care?
• What are the side effects of the treatment? How could they affect your life? Does it require hospitalization? Can you continue to take your current medications or engage in complimentary and alternative therapies that you may be using?
• Can you leave the trial at any time?
• Are there costs involved in the trial, such as having to pay for travel, meals if away for extended periods of time? Will these associated costs be picked up by the clinical trial?
• How long will the trial last?
• Could the trial impact current treatment you may be receiving?

Keep in mind that all clinical trials are voluntary. Do not be talked into something that you are not comfortable with and be sure to discuss your concerns and choices with your medical provider.

Clinical Trials: What You Need to Know from the American Cancer Society: This site provides easy to read and understand information about clinical trials. While the focus is cancer treatment, the basic information applies to any condition.

FDA Basic Questions and Answers About Clinical Trials

Clinical Trials. Gov

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