MGH Clinical Research Council Meeting
Wednesday, April 15, 2015
12:00-1:00 p.m.
MEETING AGENDA
The MGH Clinical Research Center
Progress Report and Future Directions
Dr. David Nathan and Kathy Hall
Harvard Program in Therapeutic Science
Programs and Opportunities
Dr. Laura Maliszewski
MGH Clinical Research Center
Progress 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 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
• 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
MGH Clinical Research Center
Staffing
• 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
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
Pediatric Studies
• Children ≥ 1y
Specialized Support
• 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
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
Principal Investigators
2014, 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
Visits
Growth in Utilization
Annual
visits
Protocols
Location*
• Active protocols
– Inpatient- CRC White 13 = 47 (22%)
– Outpatient = 203 (94%)
– “Scatter” = 19 (11%)
• Inpatient = 5
• Outpatient = 15
*Many studies use more than one site
MGH Clinical Research Center
Charges for Services Offered for
Investigator-initiated Protocols
• 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
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
What’s New?
• 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.
MGH Clinical Research Center
What’s New?
• 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.
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, and
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 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 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 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
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
Mason Freeman, MD- Director, Translational Research Center
freeman@molbio.mgh.harvard.edu
HiTS
Harvard 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 Pharmacology
MATLAB practicum for PK/PD
Better, faster, cheaper
Choose 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
lauram@hms.harvard.edu
Leadership
Peter Sorger
Laura Maliszewski
David Golan
Tim Mitchison
Scientific Staff
Will Chen
Catherine Dubreuil Robert Everley
Sarah Boswell
Lab Operations
Noël Peters
Joleen Pugliese Tenzin Phulchung
Mirra Chung
HiTS.harvard.edu
lauram@hms.harvard.edu
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)
Physician-Scientist
Pharmacology
Chemical Biology
Plus:
Systems Biology
Biochemistry
Synthetic Genetics-Genomics
Biology