National Pediatric Critical Care Collaborative Research Network Carol E. Nicholson, MD NIH/NICHD/NCMRR Pediatric Critical Care and Rehabilitation Research
Vision • a collaborative pediatric critical care research network of interactive clinical and translational science research groups.
Purpose and Vision -I • promote the efficient comparison of novel critical care treatment methods and management strategies of potential benefit for children and who are criticallyill and/or injured.
Purpose and Vision-II • Fund the infrastructure required for a network of six core clinical centers to perform clinical trials, translational and descriptive research in pediatric critical illness and injury
Purpose and Vision- III • Seek descriptive and translational science in the pathophysiology of critical illness in children, especially……
In survivors of childhood critical illness…. • Linking outcomes (functional and developmental) to critical illness and its management • Minimizing the effect on siblings and families of devastating childhood illness • Reintegration of child into home, school, family as the ultimate goal of critical care practice
In the subspecialty…. • Understanding the pathophysiology of critical illness, particularly multiple organ system failure (MOSF) • Evaluating practice: our own, other specialties caring for children. • Finding adequate outcome measures of pediatric critical care practice
How will the Network be Constituted ? • Up to six core clinical centers • Data Coordinating Center • NICHD assistance Project Officer Project Scientist Steering Committee Chairman
The Money……. • Total amount of “set-aside”: $5M (years 2-5) • $1M Data Coordinating Center (separate RFA) • To fund core clinical centers: $4M
How much each, for what? • Infrastructure operating costs: • Each center: direct costs: • First year $100,000 • Years 2-5 $450,000 • Full time research nurse • 10-15% PI time • Half time data entry /administrative staff
To qualify, these centers MUST….. • HAVE STRONG FOLLOWUP of CHILDREN who have devastating illness or injury • Your longer term care colleagues are looking for you….get involved!
Governance of the Network • Steering Committee consists of: • PI’s • NICHD Project Scientist • DCC PI • Chairman (NICHD appointed)
What is a Cooperative Agreement? • Substantial NICHD scientific and/or programmatic involvement with the recipient is anticipated. • An award instrument establishing an "assistance relationship” between the NIH institutes (NICHD) and a recipient.
To Clarify, a bit…. • NICHD’s purpose in this relationship : • to support and/or stimulate the recipient's activity by involvement in and otherwise facilitating the activity in a "partner" role • avoid a dominant role, direction, or prime responsibility.
How will applicants be evaluated? • Three areas • Characteristics of the Proposed Center • Principal Investigator and Identified Research Nurse • Proposed Science
Review of Applications CRITERIA include: Significance Approach Investigator Environment • Additional Review Criteria in RFA…
The review will be by a “SEP” • Special Emphasis Panel, convened by NICHD just for this purpose. • The Scientific Review Administrator will select and invite the review committee members • Not all members of the review group will be intensivists
Looking at the three aspects of theapplication to be submitted • A paradigm: preparing to board the train • Is it the right train for you? • Don’t get on the train to New York if you want to get to Kansas City
A table of the characteristics of your pediatric critical care service: # of patients in each category Institutional personnel and services Characteristics of the Center
Principal Investigator and Research Nurse • Evidence of commitment to research • Evidence of commitment to collaboration • Research Nurse must be identified at the time of application • Each Principal Investigator must be a fully qualified pediatric intensivist.
Don’t let the timing bother you…. • Publication: April, 2004 • Applications due August 9, 2004 • Anticipated funding Spring, 2005
…..Summer, 2004 • Due date August, 2004 • start now, so that summer is peaceful, and the Network applications begin to………
Things to do first! • Identify research nurse and princicpal investigator • Get buy-in at your institution….is this the right train for you? Ask the neos… • Identify the science you will propose and begin the SEVEN STEPS…make your notebook • You will need to know ages and diagnostic categories of PICU patients…..