General comments on study designs in early phase clinical studies

3 General comments on study designs in early phase clinical studies 

Participants in early clinical studies are usually healthy adults whose health status is carefully documented at the start of the study through physical examinations, clinical laboratory tests, and medical histories. Limiting early studies to 

Early clinical studies frequently involve the use of a concurrent inactive control. This can be important because the study procedures can be somewhat invasive and associated with some adverse effects themselves - for example, frequent blood draws resulting in a lowering of hematocrit. Without a concurrent control arm (even in a study of healthy participants) study sponsors and investigators would not be able to rule out a drug effect when observing such occurrences, which are expected, easily explained, and non-drug related. In early studies that involve inpatient facilities for close monitoring, other controls may be instituted, for example, standardized meals and set times for study procedures. 

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