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Clinical Trials

Posted 7/25/2014

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  A few basic facts about clinical trials to remember:

1. They are designed to test new drugs or procedures or, sometimes, equipment in all areas of medicine; they are not reserved for oncology care.

2. Everything we know about what is effective has been learned from carefully designed and executed trials. We all stand on the shoulders of women (and men) who agreed to participate.

3. They are not only for very sick people. In breast cancer care, there are plenty of trials for women with early stage cancer. Examples would include the one that I participated in long ago that compared concurrent radiation and chemotherapy with the more usual first one/then the other schedule or the current trial that is comparing the benefit of tamoxifen to that of an AI plus a monthly shot to close down ovarian function for ER positive pre-menopausal women.

4. Most clinical trials do not result in final FDA approval of new medicines.. The success rate is rather small, generally quoted as under 20% for oncology drugs.

  BIDMC, like all academic medical centers and many other practices, participates in many clinical trials and offers them to all people who are appropriate candidates. If your doctor suggests a trial as one treatment option, please consider it. And, if she does not, you might ask if there is an available trial that you should be considering.

  This is an excellent article from Living Beyond Breast Cancer about trials. I give you the start and a link:

Debunking the Myths of Clinical Trials
Published in the Summer 2014 issue of LBBC's Newsletter, Insight
Written By Nicole Katze, MA, Editor and Manager, Publications

Clinical trials, research studies in humans, are the main way new anticancer medicines and prevention and diagnosis techniques are tested and approved for use. Yet the number of adults who join cancer clinical trials is quite low. Concerns about safety and getting the best care, as well as unclear ideas of how research is done, may prevent people from enrolling.

Despite the popular belief that medical research in humans is unsafe or scary, some people find the structured care offered through clinical trials comforting. They also may see benefit in having access to new study treatments to try.

“Joining a clinical trial was the best thing I ever did,” says Fran Kamin, 51, of Lake Worth, Florida. “It’s amazing to me how many misconceptions there are.” Fran took part in BOLERO-3, a study of everolimus (Afinitor) for treating HER2-positive metastatic breast cancer. Researchers found that participants treated with everolimus lived for longer spans of time without the disease growing or spreading.

Deciding whether a clinical trial is right for you is a personal choice, but your healthcare team can help you make an informed decision.

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