Changes in Drug Development Regulations and Their Impact on Clinical Trials
Regulatory changes in the United States and Europe have stimulated major pediatric clinical trials of >18 different antihypertensive agents over the last two decades. As pediatric hypertension trials have become more common, trial designs have been refined, and we now better understand factors associated with trial success or failure. Appropriate dose range, weightbased dosing, use of a liquid formulation, and use of appropriate blood pressure (BP) endpoints are all factors that have been associated with improved trial success. Such lessons learned, together with important modifications in trial design templates, are reflected in the US Food and Drug AdministrationWritten Request criteria. The Written Request provides valuable information that can be used to design optimal future clinical trials of antihypertensive agents as well as other therapeutic agents for use in children.
