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Clinical Trials
Click Here for a listing of Active Protocols. (last updated 02/27/08)
NOTE: Trials open and close regularly at different times. To make sure a trial is still open, call 219-852-6454.
Physicians or other medical professionals may click here for a more scientific account of clinical trials.
It takes 14 years for an experimental drug to travel from the laboratory to U.S. consumers. The longest part of that process is finding people to participate in each phase of clinical trials. The more people who take part, the faster we will find better ways to treat and prevent cancer.
The purpose of the cancer research clinical trials offered at Community Hospital is to gather and evaluate information about new medications that are not yet approved by the FDA. Sometimes, a clinical trial will involve a drug already approved by the FDA for one purpose, but that is being evaluated for another use.
It is important to note that every person participating in a cancer clinical trial at Community Hospital receives treatment. While the word placebo may be included in the trial description, patients receive, at minimum, the best standard treatment in conjunction with the study medications. Placebo in these cases does NOT mean the patient is not receiving any treatment.
People choose to participate in clinical trials for many reasons. Some have exhausted all other therapy options and wish to try experimental treatment to help prolong or improve quality of life. Others wish to have access to new therapies that may benefit them, with faster healing or less side effects. Still others feel a strong sense of commitment to helping advance cancer research and help identify new therapies for those diagnosed in the future.
The following description of the phases in a clinical trial was taken from the Coalition of the National Cancer Cooperative Groups, Inc. at www.cancertrialshelp.org.
Phase I trials help researchers determine the best way to give a new treatment (by mouth, injection or IV drip, for instance) and the most appropriate dosage. These trials also establish whether a treatment has any potentially harmful side effects. As few as a dozen, but not many more than 50 or 60 people, might participate in this stage.
Phase II trials, usually involving fewer than 100 participants, evaluate whether the new treatment actually has a positive effect against a particular type of cancer. In general, if at least 20 percent of the patients respond to the treatment, the new therapy undergoes further evaluation.
Phase III trials compare the new treatment to the best existing treatment for a particular type of cancer. Many patients -- from the hundreds to even the thousands -- receive either the new treatment or the best existing treatment. For instance, many Phase III trials involve adding a new drug to an already-proven combination of drugs to see if the combination is more effective.
It's important to know that every patient in a Phase III trial receives either the standard treatment for a specific cancer or the treatment being investigated. The common misperception that some patients receive placebos has kept many patients from participating in cancer clinical trials.
Finally, Phase IV is the following of patient groups after the drug has already been approved by the FDA for that particular use.
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