Friday, March 9, 2012

Clinical Trial Basics


  • Clinical trials are research studies that involve people. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer.
  • In cancer research a clinical trial is designed to show how a particular anticancer strategy—for instance, a promising drug, a gene therapy treatment, a new diagnostic test, or a possible way to prevent cancer—affects the people who receive it.
  • A clinical trial is one of the stages of a long and careful cancer research process. Getting promising results from testing a new drug on mice, for example, is a preliminary step to human research studies. Treatments that work well in mice do not always work well in people.
  • People can benefit from clinical trials. In treatment trials, for example, participants receive high-quality cancer care—and will be among the first to benefit if a new approach is proven to work.
  • Only eligible people can participate in a clinical trial. Each study has its own guidelines for who can participate. Generally, participants are alike in key ways—such as the type and stage of cancer, age, gender, and other factors.
  • There may be drawbacks. New treatments under study are not always better than, or even as good as, standard care. And they may have unexpected side effects. Through a process called “informed consent” you will learn about a study’s treatments and tests, and their possible benefits and risks, before deciding whether or not to participate.
  • In treatment trials involving people who have cancer, placebos are very rarely used.
  • Many treatment trials are designed to compare a new treatment with a standard treatment, which is the best treatment currently known for a cancer, based on results of past research. In these studies patients are randomly assigned to one group or another.
  • Clinical trials take place all over the country—in cancer centers, other major medical centers, community hospitals and clinics, physicians’ offices and veterans’ and military hospitals.
  • Health plans and managed care providers do not always cover all patient care costs in a study. What they cover varies by plan and by study. Ask a doctor, nurse, or social worker form the study to help you determine in advance what costs are covered. The research costs, such as data management, are covered by the study sponsor.
How To Learn More About Clinical Trials:  

  1. Call the National Cancer Institute’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) and ask for a customized search of the PDQ database, which provides information on current studies.
  2. National Institutes of Health Web Sites with Lists of Clinical Trials, plus further general information about clinical trials:


SOURCE: Ten Things to Know About Treatment Clinical Trials From the National Cancer Institute, National Institutes of Health Bethesda, Maryland NIH Publication No. 00-4830

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