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10 Facts Every Woman Should Know About Clinical Trials

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Fact 1: All clinical trials are voluntary.

If you meet the criteria for a clinical trial, you always have the right to choose whether or not you will participate, and you have the right to leave a clinical trial at any time, for any reason.

The level of care you get should not be affected by your decision. If you decide to leave the study, talk to your doctor first, especially if you are on a treatment regimen. You will want to know how quitting the study might affect your health and what other treatment options you have.

You should also tell the research group that you are quitting and why. Your health care team may ask that you agree to continue to be watched for a certain length of time to look for any long-term effects of treatment.

Fact 2: Not all clinical trials study treatments.

When it comes to health research, it may appear that most research studies are all about treatments, but many clinical trials look at new ways to detect, diagnose, or learn the extent of disease. Some even look at ways to prevent the disease from happening in the first place.

Many of these studies are looking for healthy people to participate. A behavioral study, for instance could be a great way to understand how you can improve your own health while also helping others.

Fact 3: Even among clinical trials that do study treatment, not all of them study drugs.

Many clinical trials test other forms of treatment, such as new surgery or radiation therapy techniques, or even complementary or alternative medicines or techniques.

Fact 4: When clinical trials look at drugs, not all of them study new drugs.

Even after a drug has been approved for use for a specific illness, doctors sometimes find it works better when given a certain way or when combined with other treatments. It may even work on a different illness. Clinical trials are needed to study these possibilities as well.

Fact 5: Very few cancer trials involve a placebo.

A placebo is a fake treatment, inactive ingredient, or sham pill used in some types of clinical trials to help make sure results are unbiased. A placebo is sometimes called a "sugar pill." But some cancer patients mistakenly believe that enrolling in a cancer trial means they have a chance of receiving no cancer treatment at all.

“The reality is that participants in ‘randomized’ cancer treatment trials are randomly assigned to receive either the best cancer treatment currently known for their cancer, or the investigational treatment being studied to learn if it’s more effective – or sometimes both. Depending how the trial is designed, participants may not know which of the groups they’ve been assigned to. As people delve into clinical trial options, understanding this can be empowering,” says Leslie Eisenberg, spokesperson for ClinicalConnection.com, a website where people can search for clinical trials in their area and connect to the local research centers conducting them.

Fact 6: All clinical trials are conducted in distinct phases.

Each phase is designed to answer certain questions. Knowing the phase of the clinical trial is important because it can give you some idea about how much is known about the treatment being studied.

There are pros and cons to taking part in each phase of a clinical trial, and before beginning the trial, a member of the trial team will thoroughly discuss your potential benefits and risks. Don’t be afraid to ask questions, and make sure you understand what you might expect from your participation before opting into any study.

Fact 7: Not all clinical trials are conducted at major medical centers

A few years ago, major medical centers were the only ones conducting clinical trials which, for most participants, meant traveling a great distance to take part in the study, but things have changed.

Patients now have more options. This may include staying closer to home during a study or even staying with your own doctors. Ask your doctor if he or she is do involved in clinical trials. If so, you may be eligible for one of them.

Whether this is the right study for you is, of course, a question worth asking. Keep in mind, each study also has its own requirements that a person must meet to take part, known as the "Eligibility (inclusion) criteria".

Although clinical trials are now done in many different settings, this should not affect the quality of care you receive. No matter where a study is done, the same rules are in place to protect patients.

Fact 8: Several levels of safeguards are in place to help protect the people who take part in clinical trials.

Three basic principles are upheld by individuals and groups at research study sites and government agencies charged with overseeing clinical trials. These principles were first outlined in the Belmont Report during the late 1970s, and provide the basis for all research involving humans:

Respect for persons: Recognizing that all people should be respected and have the right to choose what treatments they receive.

Beneficence: Protecting people from harm by maximizing benefits and minimizing risks.

Justice: Trying to ensure that all people share the benefits and burdens of research equally.

Fact 9: All studies have some risk.

There is no fail safe clinical study, but then again, any medical test, drug, or procedure has risks. The risk may be greater in a clinical trial because some aspects of any new treatment are unknown. This is especially true of phase I and II clinical trials, where the treatment has been studied in fewer people.

Perhaps a more important question is whether the risks are outweighed by the possible benefits. People with debilitating illnesses are often willing to accept a certain amount of risk for a chance to be helped, but it is always important to be realistic about what this chance is. Ask your doctor to give you an idea of what the possible benefits are, and exactly what benefit is likely for you.

Fact 10: Participating in a clinical trial cost about the same as traditional treatment.

Recent cost analysis studies show the overall costs of taking part in a clinical trial are not much more than the costs of treatment outside of a study. However, insurance coverage can vary widely.

When insurers do cover costs related to clinical trials, it is usually only for tests, treatments, or doctor's visits that would have been part of your treatment plan if you were not taking part in a study. But many insurers are not likely to pay for special tests or treatments you are getting just because you're in the study.

One important aspect to consider is if the study sponsor is providing the new treatment at no cost and pays for special testing or extra doctor visits. Some sponsors may pay for more than this. For example, some may offer to pay you back for travel time and mileage. It is important to find out what will be paid for before entering the study.

Lynette Summerill is an award-winning writer and Scuba enthusiast living in San Diego, CA with her husband and two beach loving dogs. In addition to writing about cancer-related issues for EmpowHER, her work has been seen in newspapers and magazines around the world.

Sources and Patient Information:

Clinical Trials: What you need to know. American Cancer Society. Booklet available online for download at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003006-pdf.pdf

Leslie Eisenberg interview. 13 March 2012. More information available at: www.clinicalconnection.com

Myths and Facts About Cancer Clinical Trials. Coalition of Cancer Cooperative Groups. Acessed online: http://www.cancertrialshelp.org/Icare_content/icMainContent.aspx?intAppMode=7

Reviewed March 22, 2012
by Michele Blacksberg RN
Edited by Jody Smith

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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.


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