1. MGH Clinical Research Center Progress Report and Future Directions Kathy Hall, MS, ANP-BC, NE- BC Nurse Director, Clinical Research Center

2. 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

3. 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

4. MGH Clinical Research Center 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 Services Offered

5. MGH Clinical Research Center 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 Staffing

6. MGH Clinical Research Center 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 Staffing

7. Protocols 2014, N=214 Medicine-117 Psych-37 Peds- 47 Neuro-19 Radiology-14 117 47 19 37 6 2 14 1 2 1 Nursing-2 Anesthesia 6 Surgery-2 Genetics-1

8. Visits Growth in Utilization Annual visits

9. MGH Clinical Research Center 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 Charges for Services Offered for Investigator-initiated Protocols

10. Support for Investigators Outpatient/inpatient beds freeOutpatient/inpatient beds free Nursing/nutrition/statistics/design support all with no chargeNursing/nutrition/statistics/design support all with no charge Ancillary support for routine labs for junior investigatorsAncillary support for routine labs for junior investigators Access to inexpensive central laboratories and other CATALYST resourcesAccess to inexpensive central laboratories and other CATALYST resources Strongly suggest that investigators meet with CRC leadership before budgets submittedStrongly suggest that investigators meet with CRC leadership before budgets submitted Investigator-Initiated Studies

11. Support for Investigators Unique to CATALYST CRC- helps support lab testsUnique to CATALYST CRC- helps support lab tests Budget constraints have lead to changes over timeBudget constraints have lead to changes over time As of 10/1/15As 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)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 funding5/1/16- availability of future ancillary funding will depend on future levels of CATALYST funding Ancillary Support Available

12. Support for Investigators Represent ~10% of all CRC studiesRepresent ~10% of all CRC studies Study investigator/sponsor pays full costsStudy investigator/sponsor pays full costs –Outpatient/inpatient beds –Staffing- nursing, nutrition, other –Procedures –Lab tests Pricing of services available upon requestPricing of services available upon request Strongly suggest that investigators meet with CRC leadership before budgets submittedStrongly suggest that investigators meet with CRC leadership before budgets submitted Industry-Initiated Studies

13. MGH Clinical Research Center 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 Application

14. 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. Combined CRC and TRC MGH Clinical Research Center

15. 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 Combined CRC and TRC

16. 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

17. 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

18. 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 Clinical Research Center The Future

19. MGH CRC MGH CRC - http://massgeneral.org/crc David Nathan, MD - Program Director dnathan@mgh.harvard.edu 726-2875 Madhu Misra, MD, MPH – Pediatrics, Associate Program Director mmisra@partners.org 724-5602 Kathy Hall, MS, ANP-BC,NE-BC- Nursing Director khall7@partners.org 726-3295 Ellen Anderson, MS, RD, LDN- Nutrition Director eanderson1@partners.org 724-2830 Ed Andrews, MPA/Health – Administrative Director ebandrews@partners.org 726-6885 Contact Information Mason Freeman, MD- Director, Translational Research Center ‎freeman@molbio.mgh.harvard.edu