CHILDREN'S MERCY HOSPITAL, THE
Grant: $359,683 - National Institutes of Health - Jul. 16, 2009
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Award Description: As a direct result of receiving PPRU supplemental funding for 2009 via the American Recovery and Reinvestment Act of 2009 (Recovery Act), the Division of Pediatric Pharmacology and Medical Toxicology at CMH will be able to maintain 2.5 FTEs of research coordinator positions which historically, have been fully funded via the PPRU cooperative agreement. It is anticipated that these highly skilled and valued professionals will be able to maintained in the pediatric clinical pharmacology program at CMH through competitive re-funding of the PPRU in 2010. During 2009, the activities of the PPRU at CMH will focus on completing the majority of PPRU Network studies at the site which either remain open to enrollment or previously, have been closed to enrollment and require completion of data analysis and reporting of results. This will include all requisite data management and analysis components (eg., deposition of investigator-initiated PPRU derived data into the database maintained by the PPRU Network Operations Center). Other than initiating new sites in order to expeditiously bring existing PPRU network studies to a conclusion, the unit at CMH will not propose new investigations to the Network for consideration of initiation and completion in the remaining nine months of 2009.
Project Description: 10390 - Developmental Regulation of CYPs 1A2, 2D6 and 3A4 (Quarter1): Screened (S) = 0; Enrolled (E) = 0; Completed (C) = 3 (Quarter2): S = 0; E = 0; C = 4 (Quarter3): S = 0; E = 0; C = 0 Completion of 5 year longitudinal study. Entire cohort enrolled. 10606b - The Role of Drug Bioactivation and Detoxification in the Pathogenesis of Adverse Drug Reactions in Children (Quarter1): Screened (S) = 0; Enrolled (E) = 0; Completed (C) = 0 (Quarter2): S = 0; E = 0; C = 2 (Quarter3): S = 0; E = 0; C = 1 This study completed the end of third quarter, currently in process of data analysis and manuscript development. 10830 - Pharmacogenetics of Codeine Biotransformation in Sickle Cell Disease (Quarter1): Screened (S) = 2; Enrolled (E) = 2; Completed (C) = 0 (Quarter2): S = 4; E = 4; C = 0 (Quarter3): S = 0; E = 0; C = 0 10862 - Micafungin PK/Safety in Children and Adolescents (2101) There has been no enrollment to date. 10872 - Memantine Autism PK This study ended (was closed) in first quarter with no enrollment. 10876 - Micafungin PK/Safety in Infants and Toddlers (2102) There has been no enrollment to date. 10898 ? In vivo assessment of Histamine PG (Quarter1): Screened (S) = 3; Enrolled (E) = 3; Completed (C) = 3 (Quarter2): S = 7; E = 7; C = 7 (Quarter3): S = 8; E = 8; C = 8 10914 - Genetic polymorphisms for histamine degradation in vancomycin red man syndrome (Quarter1): Screened (S) = 39; Enrolled (E)= 38; Completed (C) = 38 (Quarter2): S = 23; E = 23; C = 23 (Quarter3): S = 36; E = 36; C = 36 Initial data analysis complete. Abstract to be presented at 2009 IDSA meeting. 10934 - PK of Meropenem in Neonates (BPCA study) (Quarter1): Screened (S) = 5; Enrolled (E) = 5; Completed (C) = 4 (Quarter2): S = 10; E = 7; C = 7 (Quarter3): S = 5; E = 5; C = 4 10948 ? PG-based Warfarin Dosing in Children (Quarter1): Screened (S) = 5; Enrolled (E) = 5; Completed (C) = 0 (Quarter2): S = 1; E = 1; C = 0 (Quarter3): S = 0; E = 0; C = 0
Jobs Summary: As a direct result of receiving PPRU bridge funding for 2009, the Division of Pediatric Pharmacology and Medical Toxicology at the Children?s Mercy Hospital (CMH) has been able to fully maintain 2.24 FTEs of research positions which historically, have been fully funded via the PPRU cooperative agreement. Maintaining these highly skilled and valued professionals preserves employment and enables the success of the PPRU at CMH through the conduct of critical clinical trials related to pediatric drug therapy. They will also be critical to maintaining the integrity of the PPRU at CMH through 2010 and beyond should the Network be continued via competing renewal. Gregory Kearns, PharmD, PhD continues as the PI of the PPRU at CMH. During 2009, his time and effort percentage dedicated to managing this award was approximately 25%; 10% of which was cost-shared by the institution so as to absorb administrative reductions in the total amount of funding available from NICHD. In 2009, Stephen Spielberg, MD, PhD, Director of the Center for Personalized Medicine and Therapeutic Innovation at CMH assumed responsibilities for the medical directorship of the PPRU. An internationally known expert in pediatric clinical pharmacology who is board certified in pediatrics and has an active medical staff appointment at CMH, Dr. Spielberg is ideally suited to serve in this role at an approximately 10% time and effort commitment. His duties for medical oversight of PPRU Network investigations are shared by Kathleen Neville, MD, MS and Jennifer Lowry, MD; board certified pediatricians and members of the CMH active medical staff; have completed clinical pharmacology fellowship training. Susan Abdel-Rahman, PharmD; Professor of Pediatrics at the University of Missouri-Kansas City and director of the PPRU Core Pharmacokinetics/Pharmacodynamics Lab at CMH continues to serve in the role of Associate Clinical Pharmacologist. Over the past 3 years, Dr. Abdel-Rahman has been a key member of the PPRU at CMH and a key contributor to PPRU NSC activities/programs. She also assists in the daily management/oversight of PPRU clinical trials. It should be noted that Dr. Abdel-Rahman has assumed responsibility for the pharmacometrics portion of the program at CMH at approximately 2% time and effort which has been reduced in proportion to the number of PPRU network studies in the CMH unit which require on-site analysis of pharmacokinetic data. Anne Holmes, BSN, RN, has served as a Nurse Coordinator for the PPRU at CMH at approximately 47% time and effort. Ms. Holmes is a pediatric nurse who has significant experience and expertise in neonatal and pediatric intensive care. She was recruited to the PPRU consequent to our evolving need to be able to conduct clinical/translational research in the neonatal intensive care unit. Ann Harris, BSN, RN, MBA, CCRC, has served as a Nurse Coordinator for the PPRU at CMH at approximately 75% time and effort. She serves as the manager for the PPRU Pediatric Research Unit and has direct supervision of all PPRU trials to ensure adherence. She is responsible for day-to-day coordination of research nurse activities associated with the PPRU Network protocols and for regulatory oversight. Casey Martinez, BPS, has served as a Patient Recruiter for the PPRU at CMH at approximately 50% time and effort. She has been retained to organize and expedite patient enrollment for PPRU studies to include a significant number of potential study subject screenings on a daily basis for inclusion in PPRU clinical trials. Nichole Ahlers, BS, has served as a Data Coordinator for the PPRU at CMH at approximately 25% time and effort. She has been retained to provide direct responsibly for all data entry to the PPRU database ensuring policy adherence with mandated periodic reporting of clinical trial-associated activities. Additionally, she maintains monthly reporting of patient enrollment to the NICHD. (Total jobs reported: 2)
Project Status: More than 50% Completed
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