Special Populations

SPECIAL POPULATIONS

One of the goals of drug development is to provide suffi-cient data to permit the safe and effective use of the drug.

Therefore, the patient population that participates in clinical trials should be representative of the patient pop-ulation that will receive the drug when it is marketed. To a varying extent, however, women, children, and patients over 65 years of age have been underrepresented in clini-cal trials of new drugs. The reasons for exclusion vary, but the consequence is that prescribing information for these patient populations is often deficient.