Summary excerpt from the Statement of Children's Clinical Research Institute: CCRi operates as an academic clinical research organization. CCRi conducts multi-center clinical trials, most but not all of which are industry-funded drug trials. Our studies have ranged from 4 to 50 sites and from 20 to 400 subjects. All of the industry-sponsored studies to date have been conducted to satisfy a Written Request issued for patent or exclusivity extension under the provisions of FDAMA or the BCPA. CCRi works with many sites on any given trial and gets to observe second hand the workings of many IRBs based on the wide range of responses to a given protocol. My views are reflected through the prism of pharmaceutical trials for children.