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Saturday, September 06, 2008
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How Are Participants Assigned to Groups?

Doctors use a process called randomization (chance) using a computer to assign you to either the intervention group or the control group in Phase III studies. This method ensures that certain factors and human choices don't affect study results, making them less reliable. When groups are compared with each other, it is clear whether the study agent works or has bad side effects. This also helps ensure that the findings really result from the study agent, and not from something else.

Most Phase III cancer prevention studies use a double-blind research design. This means that neither you nor the doctors know which people are taking the study agent or the control agent. Only the researchers at a central office know. Sometimes a doctor needs to find out if a participant has taken the study agent. A doctor can find this out, if needed, by talking with the central office staff.

No one knows whether it is better to be in the intervention or control group until the study is over and the results are ready. If that were known, there would be no need for the study. Either group may have good results or problems. The results help doctors decide whether to advise people to take the study agent for cancer prevention.



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National Cancer Institute