funding for clinical research: the nih and beyond

Funding For Clinical Research: The NIH And Beyond

Anita Liberman-Lampear, M.A.Administrative Director, UMOPC

University of Michigan Health System

With very special thanks to: Elaine Brock, Senior Associate Director, Research Administration

Julie Feldkamp, Managing Project Representative, DRDAJennifer Griggs, Associate Professor of Medicine

Steven Katz, Professor of Medicine and Health Management and Policy

University of Michigan

Grant Hunting at NIHhttp://grants1.nih.gov/grants/oer.htm

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Career Development Grants

Purpose: To propel the investigator towards independence as a funded researcher Developing skills to gain

independence Developing networks/resources

helpful in gaining independence Strengthening candidate’s abilities

to apply for additional funding

NIH Budgets by Institute

FY 2009 ChangeRequest 98-09 %

(in millions of current dollars)

Cancer 4,810 88.8%Allergy and Infectious Disease 4,569 237.9%Heart, Lung and Blood 2,925 91.0%General Medical Sciences 1,938 81.8% Diabetes, Digestive, Kidney Disease 1,872 106.3%Neuro. Disorders and Stroke 1,545 97.9%Child Health & Human Dev. 1,256 87.5%Aging 1.048 102.0%Arthritis, Musculoskeletal & Skin 509 85.1%Total NIH Budget 29,457 115.4%(Minus training & overhead 791 39.9%)

http://www.aaas.org/spp/rd/health09p.pdf

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NIH Budgets by Funding Mechanism

(sampling)

FY 2009 ChangeRequest 98-09 %

(in millions of current dollars)

Research Project Grants 14,903 97.2%SBIR/STTR* Grants 620 130.5%Research Centers 2,963 153.7%R&D Contracts 3,275 303.4%

Total NIH Budget 29,457 115.4%*Small Business Innovative Research Grant (SBIR) http://www.sbir.gov/Small Business Technological Transfer Grant (STTR) http://grants.nih.gov/grants/funding/sbir.htm

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Position Your Research For Success

Find the vision; Find the inspiration Find the opportunities at NIH Engage mentors about strategic planning Engage the NIH staff about opportunities Understand the review process at NIH Write the best proposals Build a track record

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Investigator Initiated Research Proposals

Unsolicited Response to a PA (program announcement)

Describes institute research priorities Intended to motivate proposals in the research area Stipulates grant mechanisms (R01, R21, R03) PAs are generally ignored in the section review process May help in close call funding decisions

Response to a RFA (request for applications) Separate allocation of funds for the initiative Ad hoc study section assembled

Response to a RFP (request for proposals) A call for contracts

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Engage the NIH staff

Learn about the organizational chart Contact project officers Get to know program directors Meet and greet at NIH Consider organizational dynamics

Staff perspectives Staff turnover

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Center for Scientific Review at NIH Manages the review process for most

research applications at NIH Reviewers are organized in multidisciplinary

sections Regular standing (“chartered”) sections

Receive applications across institutes Develop greater continuity and

cohesive culture Special Emphasis Panels

Ad hoc with less continuity May review applications from within or

across institutes Chartered sections: http://www.nih.gov/icd/

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AARR AIDS and Related Research Integrated Review Group

BBBP Biobehavioral and Behavioral Processes Integrated Review Group

BCMB Biological Chemistry and Macromolecular Biophysics Integrated Review Group         

BDA Biology of Development and Aging Integrated Review Group

BDCN Brain Disorders and Clinical Neuroscience Integrated Review Group

BST Bioengineering Sciences & Technologies Integrated Review Group

CB Cell Biology Integrated Review Group         

CVS Cardiovascular Sciences Integrated Review Group

DIG Digestive Sciences Integrated Review Group

EMNR Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group

GGG Genes, Genomes, and Genetics Integrated Review Group         

HEME Hematology Integrated Review Group

HOP Health of the Population Integrated Review Group

IDM Infectious Diseases and Microbiology Integrated Review Group         

IFCN Integrative, Functional and Cognitive Neuroscience Integrated Review Group

IMM Immunology Integrated Review Group

MDCN Molecular, Cellular and Developmental Neuroscience Integrated Review Group

MOSS MUSCULOSKELETAL, ORAL AND SKIN SCIENCES INTEGRATED REVIEW GROUP

ONC Oncological Sciences Integrated Review Group

RES Respiratory Sciences Integrated Review Group

RPHB Risk, Prevention and Health Behavior Integrated Review Group

RUS Renal and Urological Studies Integrated Review Group

SBIB Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group

Chartered Sections by Category

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Understanding the NIH review process

General structure and process of review Role of SRA (scientific review

administrator) Role of PO (program official) Section Review Processes Merit score measures Review guidelines for R mechanism Considerations for new investigators New multiple PI option

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Priority score measures Significance Innovation Approach

Conceptual framework Design and feasibility Data collection methods Analysis plan

PI and research team Environment Protection of human subjects

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Review criteria for different Rs R21- exploratory grants

The goal is research development leading to larger studies

More emphasis on significance in the context of next steps

Less emphasis on details of methods Preliminary studies are not required Limited budget

R03 More emphasis on significance and conceptual approach Less emphasis on detail of methods Limited budget

R01 new investigator category less emphasis on preliminary studies and experience of

the PI Percentile pay line may be higher

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Attributes of Strong Proposals Appealing formats Crisp specific aims and hypotheses Compelling and concise background

section Thoughtful conceptual model Preliminary studies section that addresses

challenges to the proposed research Measures linked to variables and analysis

plan Crisp description of data collection

procedures and data management using figures

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Attributes of Strong Proposals (cont’d)

Clear power analyses with tables of effect sizes anchored by text addressing clinical importance

Protection of human subjects described using PHS application instructions to the letter

Figure of the timeline with few stretch marks

Requested resources are appropriate for scope of work

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Funding Decisions

Priority scores are used to calculate a percentile rank

Funding decisions are made by institute staff based on the rank score of the grant against the payline

Rank scores just above the payline occasionally are selected for funding

Unfunded proposals may be resubmitted twice

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New investigators New investigators are encouraged to apply New investigator category for R01s

Less emphasis on preliminary data Higher payline

R03 and R21 applications are limited to 10 pages and do not require deep preliminary data sections

Demonstrated collaboration on a productive team in a related area is a key ingredient to success

Get some experience on a study section

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Hunting for Support Outside the NIH Forest

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Federal Agencies

Discovery Driven, e.g.: National Science Foundation (NSF)

http://www.nsf.gov/funding/ National Institutes of Health (NIH)

Program Driven, e.g.: Department of Defense (DOD)

http://www.federalgrantswire.com/department-of-defense-federal-grants.html National Aeronautics & Space

Administration (NASA)http://science.nasa.gov/researchers/research-opportunities/

Environmental Protection Agency (EPA)http://www.epa.gov/epahome/grants.htm

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GO TO http://grants.gov/ Key benefits include:

A single source for finding grant opportunities. A standardized manner of locating and learning

more about funding opportunities. A single, secure and reliable source for

applying for Federal grants online. A simplified grant application process with

reduction of paperwork. A unified interface for all agencies to announce

their grant opportunities, and for all grant applicants to find and apply for those opportunities.

In addition to simplifying the grant application process, Grants.gov also creates avenues for consolidation and best practices within each grant-making agency.

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Trade & Professional Associations and Public Charities

American College of Surgeons Oral and Maxillofacial Surgery

Foundation • Health Insurance Association of America American Cancer Society American Medical Association Plastic Surgery Educational Foundation American Orthotics & Prosthetics

Association

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Finding an Industry Sponsor

• personal contacts of the investigators• other faculty - search of internal databases,

websites• location of graduates• encounters at conferences and papers• search of external on-line databases, websites• announced opportunities• books, publications

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Statement of WorkThe statement of work in an industry sponsored project is critical since it determines:

- Sponsor’s interest in the project

- Intellectual property rights that will be offered to sponsor

- Publications that may be reviewed by the sponsor

- Overlap with other research

- Need to use existing intellectual property

- Need to access sponsor confidential information

- Cost of and use of various personnel

- Appropriateness of activity in the university

- Appropriateness of student participation

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Industry sponsorship requires a balance between what the

Investigator wants (i.e., research $$ now) versus what the industry

sponsor wants (i.e., direct benefit from data, or intellectual property

very soon)

Maintaining a realistic perspective about potential outcomes in industry-sponsored

research is important for both parties.

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Materials Transfer Agreements, Nondisclosure Agreements, and other

Agreements with Industry

In addition to funding from industry universities actively solicit proprietary

materials, software, data, equipment, etc. and are able to accept proprietary information

from our industry partners.

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NIH COMPETING R01-EQUIVALENT* APPLICATIONS: TRENDS IN NUMBER, AWARDS AND SUCCESS RATES FY 1998-2007

0

5

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1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Fiscal year

Num

ber o

f App

licat

ions

and

Aw

ards

(in

thou

sand

s)

0%

5%

10%

15%

20%

25%

30%

35%

40%

Reviewed Awarded Success Rate

* R01-Equivalent Grants include R01, R23, R29, and R37 mechanisms

Succ

ess

Rat

e

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Section pearls: Help your reviewers help you

Write with clarity, grace, and humility Direct their attention through appealing

formats Summarize key concepts throughout the

application Teach them in the background section Consider KISS to avoid the death spiral Follow NIH instructions on description of

protection of human subjects Justify your budget with detailed timeline

and clear description of resources

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Section pearls for investigators: Understand your reviewers

You are seeking to impress 3 people who are pressed to read 8 grants in 2 weeks

Imagine your reviewers will read your grant on a Sunday afternoon instead of spending time with their kids

Reviewers have a few minutes to justify their score and influence the section. They have a couple of minutes in rebuttal.

Reviewers have known skills and interests

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Foundations

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Foundations

Foundations are often known for donations to the arts, hospitals, education, etc.

More foundations are also giving to the sciences for various reasons. To get started go to:

http://foundationcenter.org/

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Foundations

Foundation Center’s Proposal Writing Short Course http://foundationcenter.org/

getstarted/tutorials/shortcourse/ It is a different source of funding that

might be more viable to the non-academic setting wishing to do research.

Some large insurers have foundations such as BCBS.

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Foundations

You might also try disease-specific organizations/foundations such as the Muscular Dystrophy or American Diabetes Associations.

How are foundations most different? Some are not peer-reviewed Regional foundations Family foundations

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Foundations Greater focus on long-term

outcomes/impacts Does this SOLVE the problem? How

does it contribute? Why should they care?

Often a great focus on underserved populations

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Foundations

They also have different rules for funding then grants do – they may or may not pay for salaries, for example.

On the other hand they may allow expenses not allowed on federal grants.

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Why do foundations give grants?

They must. Their tax exempt status requires that foundations spend or gift 5% of their asset base or pay stiff taxes and penalties.

Usually, the founder sets aside some wealth (for tax reasons or other), sets out a vision and priorities for “legacy.” These define a foundation’s programs.

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Why do foundations give grants?

How the staff members tell this story speaks volumes about the values –learn about ‘why’ by listening closely and reading between the lines.

Often in foundations there are donors or descendants on the board or in other leadership positions, continuing to influence choices. The dynamics between board and staff can be challenging.

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Final Notes

Can be overwhelming at best and darn right frustrating at worst.

If you are serious, take the time, follow the directions, the funding is there, you have to figure out how to be the winner

O&P needs more folks like you, we need to prove what we do is credible and reimbursement-worthy.

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THANK YOUUniversity of Michigan