Pediatric Research Network for Pain (PRN-Pain): Inaugural Investigator Meeting Project Abstract The aim of this conference is to establish the Pediatric Research Network for Pain (PRN-Pain), a multicenter consortium to design and implement clinical trials to prevent and alleviate pain in infants and children. Currently the overwhelming majority of medications are prescribed to children """"""""off label,"""""""" as younger individuals are rarely included in clinical trials necessary to obtain indications for that age group. Because these safety and efficacy data are held at such a high premium, the Best Pharmaceuticals for Children Act and Pediatric Rule provide incentives for industry to conduct such trials. However, in the case of analgesics, ethical, methodological, and pragmatic obstacles have limited progress, frustrating the FDA, and pharmaceutical sponsors, and providers. A research group offering expertise in innovative trial design, study implementation with sufficient power, and evaluation of results is needed to bridge this gap. In 2004, a panel sponsored by the FDA and NICHD defined many methodological challenges in conducting analgesic research in preterm and newborn infants. In 2009, the FDA convened a consensus panel to examine issues of extrapolation of data from adult studies to younger populations and to help define valid methodologies consistent with the ethical and pragmatic demands of conducting research with young children. It was deemed that a collaborative research group would provide an efficient means to those ends, an idea that was presented and reaffirmed at four major scientific meetings, ultimately leading to over 30 organizations expressing interest in participating. We now intend to convene an initial investigators'meeting to charter the organization, defining the mission statement, principles of the organization, structure of governance, and criteria for and responsibilities of member institutions, establishing a related 501-C entity that will focus on fund-raising, and designing stages of implementing the research consortium infrastructure.
Pediatric Research Network for Pain (PRN-Pain): Inaugural Investigator Meeting Project Narrative We wish to hold a conference focusing on the development of a research consortium that will provide expertise in the design, implementation, and data analysis of studies on pain relief in children. Once established, the Pediatric Research Network for Pain (PRN-Pain) will offer protocolized approaches to various pain problems, including pharmacological, interventional, psychological, physical, and complementary and integrative paradigms, all to continuously improve outcomes and alleviate suffering in children of all ages. Figure 1 provides a schematic of the functioning of this research organization.
