Drug trials in children: ethical, legal, and practical issues.

Technical limitations, logistic challenges, and ethical constraints no longer provide excuses for not conducting well-designed studies of therapeutic agents in children. In fact, to not do so is difficult to defend ethically. Clinical trials in children are feasible and essential for safe and effective use of medications in children. The time is long past when drugs with therapeutic potential in children should be marketed with labeling for use only in adults.