Clinical trials – a guide for CAB members (page 15)

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• The protocol for a clinical trial describes exactly who may volunteer to participate in the trial—who is “eligible”—and who may not.
• There are several purposes for deciding who is eligible. One is to make sure all the volunteers who join the study share certain health characteristics. The second is to leave out of the study those who may be harmed by the medications because of health problems they have. The third purpose is to increase the chances that those for whom the medicine will be helpful are participating in the study.
• Example: Imagine a study with the goal of finding out if a medicine can prevent tuberculosis in infants who have been exposed to HIV during pregnancy. The research question is “Can this medicine prevent TB in infants exposed to HIV at birth?”
• Those who are eligible to be in the study must be infants who 1) were exposed to HIV at birth, 2) are healthy enough to take the medicine, and 3) are not taking another medicine that would cause a bad effect with the new medicine. Those who are not eligible are infants who are already sick with TB. The research question can’t be answered correctly unless each participant has all of the 3 characteristics and all infants with TB are excluded from the study.