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.

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


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


• 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


• 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


• 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


• 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


• 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


• 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


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

http://massgeneral.org/crc

• 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?


• 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.


What’s New?



• 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


• 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 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

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:

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.

Documents

bch slide

site slide

research administration

outpatient protocols

pediatric investigators

laura maliszewski slide

rare services

usual services