Transcript MGH PCIR
MGH Clinical Research Center Progress Report and Future Directions Kathy Hall, MS, ANP-BC, NE- BC Nurse Director, Clinical Research Center MGH Clinical Research Center • Formerly Bulfinch 4, Mallinckrodt GCRC - One of oldest “human laboratories” in US (1925) - Continuously funded by NIH since 1961 • Currently part of Harvard CATALYST Clinical Translational Science Program (2008) - Combines four major CRCs at Harvard: MGH, BWH, BIDMC, BCH MGH Clinical Research Center In addition to the CRCs, Harvard CATALYST provides additional centralized research support o Laboratory services o Biostatistical consultation (with MGH CRP) o Bioimaging o Education (with MGH CRP) o Pilot grants o Training grants o Assistance with multi-center, cross-institutional studies MGH Clinical Research Center Services Offered • 5 bed inpatient unit- White 13 • Outpatient units- White 13 and CNY • Off-site support • Help with design and conduct of clinical studies - Planning and design- mentoring - Implementation Nursing orders and support Nutrition orders and support - Conduct of studies Nursing Nutrition Lab support- sample preparation Procedures MGH Clinical Research Center Staffing • Nursing services (RNs and NPs) - Help with study design, in particular practical implementation - Patient care- clinical and research - Administration of study medications and other interventions - Physiologic monitoring - Frequent sampling of biologic fluids - Adult and Pediatric services (all ages) - RNs all comfortable with pedi, 7 with pedi speciality - 3 FNPs and 2 ANPs to help support PI in work MGH Clinical Research Center Staffing • Nutrition services (RDs) - Specialized diets - Monitoring intake - Anthropometrics - Bone density, body composition measurements - Metabolic cart measurements- oxygen consumption - Exercise tolerance testing - 1 RD pediatric certified, - All RDs work with adult and pediatric populations Nursing-2 Protocols 2014, N=214 Medicine-117 Medicine Peds Neuro Psych Anesthes Surgery Radiology Genetics Nursing Phys Med Slice 11 Slice 13 Slice 15 Slice 16 117 47 19 37 6 2 14 1 2 1 Visits Growth in Utilization Annual visits MGH Clinical Research Center Charges for Services Offered for Investigator-initiated Protocols • All services for approved protocols provided free of charge except for services that are above usual/standard services offered, e.g. - Nursing services that require 1 on 1 care Frequent blood draws DEXA scans- surcharge per scan Weighed meals Support for Investigators Investigator-Initiated Studies • Outpatient/inpatient beds free • Nursing/nutrition/statistics/design support all with no charge • Ancillary support for routine labs for junior investigators • Access to inexpensive central laboratories and other CATALYST resources • Strongly suggest that investigators meet with CRC leadership before budgets submitted Support for Investigators Ancillary Support Available • Unique to CATALYST CRC- helps support lab tests • Budget constraints have lead to changes over time • As of 10/1/15 – Ancillary support for senior faculty (Associate Professor and higher) no longer available • 5/1/15-4/30/16 (junior faculty only) – For studies previously awarded ancillary support, funding at $50 per visit (maximum) will continue – For new studies, junior faculty can request up to $2500 per study • 5/1/16- availability of future ancillary funding will depend on future levels of CATALYST funding Support for Investigators Industry-Initiated Studies • Represent ~10% of all CRC studies • Study investigator/sponsor pays full costs – Outpatient/inpatient beds – Staffing- nursing, nutrition, other – Procedures – Lab tests • Pricing of services available upon request • Strongly suggest that investigators meet with CRC leadership before budgets submitted MGH Clinical Research Center Application Applications from a faculty level investigator (similar to HRC application) go through - centralized scientific review (if not previously peer-reviewed) and - local resource review http://massgeneral.org/crc MGH Clinical Research Center Combined CRC and TRC • Combined unit with new MGH Translational Research Program. • Translational Research Center - A new clinical research center dedicated to supporting first in human (Phase 1 and 2), bench to bedside types of study, especially geared to working with industry - Unit being established with funding from hospital under direction of Mason Freeman, M.D. MGH Clinical Research Center Combined CRC and TRC • Combined Clinical and Translational Research Center - - - New combined unit being constructed on White 12, with part of White 13 retained (~50% larger than current CRC). o 16 inpatient beds o Outpatient space with procedure room The new combined unit will take advantage of CRC staffing and expertise and provide synergy between the two operations. Anticipated opening in 15 months (~8/16) MGH Clinical Research Center The Future • The Catalyst program is supported by a Clinical Translational Science Award program grant from NCATS as well as contributions from Harvard, HMS, and the AHCs. • Our grant has another 3-years of support. • The most recent RFA issued by NCATS includes: - Far less funding ($10 million per year) than we have in our current grant and Reduced support for CRCs. MGH Clinical Research Center The Future • If the RFA issued most recently by NCATS is continued at the time of our renewal, the current CRC would lose much of its NIH support. • NIH support for clinical research would have to revert to the sponsoring Institutes. MGH Clinical Research Center The Future • MGH is committed to clinical research. • If the NIH support is reduced, the MGH will find a way to continue support of the CRC. MGH CRC Contact Information MGH CRC - http://massgeneral.org/crc David Nathan, MD - Program Director [email protected] 726-2875 Madhu Misra, MD, MPH – Pediatrics, Associate Program Director [email protected] 724-5602 Kathy Hall, MS, ANP-BC,NE-BC- Nursing Director [email protected] 726-3295 Ellen Anderson, MS, RD, LDN- Nutrition Director [email protected] 724-2830 Ed Andrews, MPA/Health – Administrative Director [email protected] 726-6885 Mason Freeman, MD- Director, Translational Research Center [email protected]