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Understanding Clinical Trials

Posted 10/21/2014

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  There are a lot of myths and misconceptions about clinical trials. Let's begin here with a short fact sheet that has been developed for our patients:

BIDMC is an academic medical center and a founding member of the Dana Farber Harvard Cancer Center. This means that our commitment is both to excellence in patient care and participation in research to better understand and treat cancer.
If you are interested in learning more about cancer clinical trials, the National Cancer Institute has an excellent website:
As you and your doctors begin to consider the best treatment for you, here are some things to remember about clinical trials:
** Clinical trials are conducted in every Department throughout the Medical Center.
** Clinical trials are designed to help patients with all kinds of diseases and problems. They are not only for very ill people who have no other options.
** Everything we know about good treatment for cancer is because people have agreed to participate in trials in the past. Everything we are learning for the future is because people are now willing to consider being part of an appropriate trial.
** If you would like to know more, talk with your doctors.

  There are a few basic things to remember: Most drugs (not just cancer drugs) that are investigated in clinical trials do not end up on the market. Approximately 1 in 12 drugs are eventually approved. As discouraging as this sounds, it is also important to remember that there are occasional huge successes. Think about Gleevac for chronic leukemia or herceptin for breast cancer. More frequently, drugs go through all phases of trials and, if approved, bring cancer treatment a little further along.

  There are three phases of trials, and the goals of each are different. Phase 1 clinical trials are the first time that drugs have been given to humans, and the central question is safety as the maximum tolerated dose is established.. Phase 2 drugs are tested, at that dose, on more people in order to gather more information. Does this particular drug warrant further study? Phase 3 drugs are the time that the new medication is compared to existing treatment; this is when we learn whether new drug X is more effective than standard drug Y.

  I am giving you a link here to an excellent summary from a talk by Dr. Clifford Hudis at the Living Beyond Breast Cancer Conference earlier this fall. Although he was talking about the development of breast cancer drugs, the facts are the same for all cancer research.

The "Bible" of information is from the NCI website. Here is a quote and a link to the home page. If you are thinking or wondering about trials, this is the place to start.

Clinical trials are research studies that involve people. They are the final step in a long process that begins with research in a lab. Most treatments we use today are the results of past clinical trials.

Cancer clinical trials are designed to test new ways to:

Treat cancer
Find and diagnose cancer
Prevent cancer
Manage symptoms of cancer or side effects from its treatment
Any time you or a loved one needs treatment for cancer, clinical trials are an option to think about. Trials are available for all stages of cancer. It is a myth that they are only for people who have advanced cancer that is not responding to treatment.

Every trial has a person in charge, usually a doctor, who is called the principal investigator. The principal investigator prepares a plan for the trial, called a protocol. The protocol explains what will be done during the trial. It also contains information that helps the doctor decide if this treatment is right for you.




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