OncoLog: M. D. Anderson's report to physicians about advances in cancer care and research.
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From OncoLog, October 2006, Vol. 51, No. 10

House Call: Should You Take Part in a Clinical Trial?

Clinical trials are research studies that involve people, with the hope of finding better ways to prevent, diagnose, or treat a disease like cancer. Patients who participate in a clinical trial receive drugs or procedures that already have been researched in successful laboratory and/or animal studies.

Many of today’s standard cancer treatments are based on the results of previous clinical trials.

When you’ve been diagnosed with cancer, deciding whether it’s best for you to participate in a clinical trial is an important decision between you and your doctor. You’ll want to consider all your options, weigh how likely it is that standard treatment will help, and evaluate the risks and benefits of joining a trial. All patients who take part in clinical trials are volunteers and can stop their participation at any time.

Q: What are the types of clinical trials?

  • Therapeutic trials test new drugs, surgery techniques, radiation therapy procedures, or other treatment methods on people with specific types and stages of cancer.
  • Prevention trials study how healthy people may prevent cancer. People at high risk of getting cancer may benefit from participating.
  • Early-detection/screening trials discover ways to find early-stage cancer.
  • Diagnostic trials find better ways to determine if someone has cancer and, if so, where the cancer is located, how much cancer is there, and whether or not it has spread.
  • Quality of life/supportive care trials seek to improve the comfort and quality of life of patients and their families or caregivers.

Q: What are the phases of clinical trials?

Once the drug, device, or procedure enters the clinical trials process, it must go through several phases:

  • Phase I trials determine the safety of a new treatment.
  • Phase II trials determine whether a certain kind of cancer responds to a new treatment.
  • Phase III trials study whether a new treatment is better than standard treatment.
  • Phase IV trials find more information about a new treatment that has been already approved for use in patients.
  • FDA Approval: Researchers submit their clinical trial results to the the U. S. Food and Drug Administration (FDA), and based on the information, the FDA may approve the drug or treatment. Then it becomes available to all patients and sometimes becomes the new standard treatment.

Q: What are the risks and benefits of participating in a clinical trial?

Some possible benefits of participation:

  • You may have more treatment options
  • If a new drug or treatment works, you may be among the first to benefit
  • You may be able to help future cancer patients
  • The trial sponsor may pay for some of your medical care or tests.

Some possible risks of participation include:

  • Side effects may be worse than those from standard treatment
  • New treatments do not always turn out to be better than, or as good as, standard treatment
  • The new treatment may not work for you even if it works for other patients
  • Your health insurance company may not pay for your clinical trial care or tests.

Q: Where can I find more information?

  • National Cancer Institute: www.cancer.gov/clinicaltrials, (800) 4-CANCER.
  • M. D. Anderson Cancer Center: www.clinicaltrials.org, (800) 392-1611, option 3.
  • CenterWatch: Clinical Trials Listing Service: www.centerwatch.com. This site lists trials for all types of health conditions.
  • Current Controlled Trials: www.controlled-trials.com. This site lists trials from many nations and agencies, and it covers all health care areas.
  • U.S. National Institutes of Health: www.clinicaltrials.gov.
  • Finn R. Cancer Clinical Trials: Experimental Treatments & How They Can Help You. Sebastopol, Calif: O Reilly & Associates Inc; 1999.
  • Getz K, Borfitz D. Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials. Boston, Mass: CenterWatch; 2002.
  • Mulay, M. Making the Decision: The Cancer Patient’s Guide to Clinical Trials. Sudbury, Mass: Jones & Bartlett; 2002.
  • Researching clinical trials. In: Oster N, Thomas L, Joseff D. Making Informed Medical Decisions. Sebastopol, Calif: O Reilly & Associates Inc; 2000:148-180.

For more information on this topic or for questions about M. D. Anderson’s treatments, programs, or services, call askMDAnderson at (877) MDA-6789.

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