What are clinical trials and how do I find one?

Many patients who receive bone marrow or cord blood transplants (also called BMT) are asked to consider being part of a clinical trial during their treatment.

Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol, includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.

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Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. All clinical trials have guidelines about who can participate.

If you decide to take part in a clinical trial, you should understand that:

• The treatment being tested may or may not help you. You may get better, you may see no change or you may get worse.
• Your participation helps doctors learn more about the treatment being tested. This knowledge may help many patients in the future. It may not help all the patients who are in the trial.
• Some trials offer experimental treatments that you cannot receive outside the trial. Other trials compare standard treatments that you may be able to receive without being in the trial.
• In a randomized trial, you may receive the treatment being tested or you may receive the standard treatment. You will not know ahead of time which treatment you will receive.

The FDA and the Office of Human Research Protections require that patients give informed consent before joining a clinical trial. Informed consent means that the patient has been told about and understands the possible risks and benefits before agreeing to be in the trial.

You can begin your search for a clinical trial by talking to your doctor. You can also find out about clinical trials using resources on the Internet.

• Transplant-related trials conducted by the National Marrow Donor Program® (NMDP)* or BMT CTN.
• http://www.bmtctn.net - Blood and Marrow Transplant Clinical Trials Network (BMT CTN) website. BMT CTN sponsors transplant-related clinical trials.
• http://www.clinicaltrials.gov - Database of clinical trials maintained by the National Institutes of Health.
• http://cancertrials.nci.nih.gov - Database of cancer clinical trials maintained by the National Cancer Institute (NCI). This website also has information about NCI Cooperative Cancer Centers, where many clinical trials are done.
• http://www.cancertrialshelp.org - Coalition of National Cancer Cooperative Groups website. This site has information about groups that operate clinical trials that include several medical centers working together.

Reference: http://marrow.org
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