Clinical Therapeutics and the Recognition of Drug-Induced Disease

Table 1:
Limitations of Premarketing Clinical Trials

Short duration -

effects that develop with chronic use or those that have a long latency period are impossible to detect

Narrow population -

generally don't include special groups (e.g., children, elderly) to a large degree, and are not always representative of the population that may be exposed to the drug after approval

Narrow set of indications -

those for which efficacy is being studied and don't cover actual evolving use

Small size - (generally include 3,000 to 4,000 subjects)

effects that occur rarely are very difficult to detect

Return to the Table of Contents