Water under the Bridge: Postmarketing Concerns as Related to Pediatric Populations

Abstract

Bringing new drugs to market in an era of cost containment and managed care requires a major shift in clinical priorities and systems. For drug manufacturers to maximize their research and development (R&D) expenditures, pre- and post-marketing activities must be carefully coordinated to obtain the longitudinal data required for valid outcomes-based information and analysis.

Part of this process entails enrolling more children in pre- and post-marketing surveillance studies. Many diseases have their origins in childhood, and gathering longitudinal data, by definition, requires that study subjects be “rolled over” on a continuing basis in order to achieve truly meaningful results. Drug testing in children, however, raises complex legal, ethical, clinical, and practical considerations that must be resolved before the goals of managed care—disease prevention and outcomes management assessment—can be reached.

Despite the difficulties of pediatric testing, providers, caregivers, and drug manufacturers must support the evolution from classical pre-/post-marketing surveillance to more efficient, coordinated study designs that include longitudinal and pediatric data. To continue to resist or delay this evolution is to fight the inevitable—which is so much “water under the bridge.”