mgh clinical research council meeting wednesday, april 15, 2015 12:00-1:00 p.m. meeting agenda the...
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MGH Clinical Research Council Meeting
Wednesday, April 15, 201512:00-1:00 p.m.
MEETING AGENDA
The MGH Clinical Research Center Progress Report and Future Directions
Dr. David Nathan and Kathy Hall
Harvard Program in Therapeutic SciencePrograms and Opportunities
Dr. Laura Maliszewski
MGH Clinical Research CenterProgress Report and Future Directions
David M. Nathan, M.D.
Director
Kathy Hall, MS, RNCS, ANP-BC
Nurse Director
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 serviceso Biostatistical consultation (with MGH CRP)o Bioimagingo Education (with MGH CRP)o Pilot grantso Training grantso Assistance with multi-center,
cross-institutional studies
MGH Clinical Research Center
• 6 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
MGH Clinical Research Center
• Nursing services (RNs and NPs)- Help with study design, especially regarding
practical implementation - Patient care- clinical and research- Administration of study medications and other
interventions- Physiologic monitoring- Frequent sampling of biologic fluids- Patient care
Staffing
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
Staffing
Pediatric Studies
• Children ≥ 1y• 28 pediatric investigators with 12 Inpatient and 43
outpatient protocols• Nursing
– 7 RNs with specialty in pediatric practice – 3 Family NPs– 4 Adult NPs who can see children ≥ 13y– All RNs do pediatric phlebotomy and visits
• Nutrition – All RDs complete pediatric visits– One RD is pediatric certified
Specialized Support
Protocols2014, N=214
Medicine-117
Psych-37
Ped
s- 4
7
Neuro-19
Rad
iolo
gy-14
117 47 19 37 6 2 14 1 2 1
Nu
rsing
-2
Anesthesia 6
Su
rgery-2
Gen
etics-1
Principal Investigators2014, N=120
Of the 120 active principal Investigators:N (%)
Professors 24 (20)Associate 32 (27)Assistant 38 (32)Instructors 26 (22)
Total number of investigators > 300
VisitsGrowth in Utilization
Annualvisits
Protocols
• Active protocols– Inpatient- CRC White 13 = 47 (22%)–Outpatient = 203 (94%)–“Scatter” = 19 (11%)
• Inpatient = 5• Outpatient = 15
Location*
*Many studies use more than one site
MGH Clinical Research Center
• All services for approved protocols provided free of charge except for relatively rare services that are above usual 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 forInvestigator-initiated Protocols
Support for Investigators
• 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
Investigator-Initiated Studies
Support for Investigators
• 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
Ancillary Support Available
Support for Investigators
• 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
Industry-Initiated Studies
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
• Medical Research Officer Program- Provides NP and MD support specifically to non-MD or non-MGH investigators who are not credentialed to provide clinical care/supervision required and for MGH investigators who need assistance.
• Combined unit with new MGH Translational Research Program.
What’s New?
MGH Clinical Research Center
• Medical Research Officer Program- Provides NP and MD support specifically to non-MD or non-MGH investigators who are not credentialed to provide clinical care/supervision required and for MGH investigators who need assistance.
• Combined unit with new MGH Translational Research Program.
What’s New?
MGH Clinical Research Center
• 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, and
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
• Combined Clinical Research Center- New combined unit being constructed on
White 12, with part of White 13 retained (~50% larger than current CRC).o 16 inpatient bedso 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 CenterCombined CRC and TRC
• The Catalyst program is supported by a Clinical Translational Science Award program grant from NCATS and by contributions from Harvard, HMS, and the AHCs.
• Our grant has another 3-years of support.• The most recent RFA issued by NCATS has
- Far less funding ($10 million per year) than we have in our current grant and
- Reduced support for CRCs.
MGH Clinical Research CenterThe 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 CenterThe 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 Clinical Research CenterThe Future
MGH CRC
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
Contact Information
Mason Freeman, MD- Director, Translational Research Center [email protected]
HiTSHarvard Program in Therapeutic Science
HiTS is…
Inter-institutional translational research program linking HMS, FAS and the Harvard hospitals with MIT and Tufts
Non-departmental, serving all of Harvard
HiTS is Quad-based to provide a touch down space for clinical faculty
Forward-looking in training students and postdocs for a variety of careers
Entrepreneurial, advancing the team-science concept
Supported by a diverse funding portfolio from federal, private, industrial and state sponsors
HiTS has Four Interlinked Components
Research combining advanced measurement methods with computational modeling to better understand drug action in man.
Reinventing the methods used for the evaluation of safety and efficacy of novel agents and applying failure analysis to inform development.
Training pioneers to bridge the translation gap through rigorous study and real world internships in industry, clinical research and regulatory evaluation.
Enhancing the research infrastructure to enable therapeutic development in partnership with HMS departments and leadership.
Therapeutics Graduate Program
HILS-wide certificate program that provides a rigorous curriculum and builds a community of PhD students and faculty with common interests in Therapeutic Sciences.
Required ‘real world’ internship in clinical research, industry or at the FDA
• Molecular Pharmacology Chemical Biology, Biochemistry, Biomarkers, Genetics
• Clinical Investigation Toxicology, Regulatory Science, Clinical Trials
• Quantitative Systems PharmacologyMATLAB practicum for PK/PD
Better, faster, cheaperChoose three of the above (Josh Boger)
LSP: Lab space for collaboration
Get Involved
June 5 Spring Symposium and Poster Session 4pm, TMEC atrium
Meet the students, postdocs and research staff
Join the monthly faculty meeting
Search for a faculty Director opening fall 2015
Lecture at the Therapeutics seminar series
Host graduate interns for 4 months
Advise on new curriculum development (MSc/PhD)
HiTS.harvard.edu [email protected]
Laura Maliszewski
Noël Peters
Will Chen Catherine Dubreuil
Joleen Pugliese
Robert Everley Sarah Boswell
Scientific Staff
Lab Operations
Leadership
Mirra ChungTenzin Phulchung
Peter Sorger David Golan Tim Mitchison
June 5 Spring Symposium and Poster Session 4pm, TMEC atrium
Meet the students, postdocs and research staff
Join the monthly faculty meeting
Search for a faculty Director opening fall 2015
Lecture at the Therapeutics seminar series
Host graduate interns for 4 months
Advise on new curriculum development (MSc/PhD)
HiTS.harvard.edu [email protected]
Physician-Scientist Chemical BiologyPharmacology
Systems Biology Biochemistry Genetics-GenomicsSynthetic Biology
Plus:
