Clinical Applications and

Prevention BranchLawrence J Fine, M.D. ,Dr.P.H.Branch Chief

Finel@mail.nih.gov 301-435-0305

Division of Prevention and Population Science

2

Heart Lung Blood Us!!

Division of ApplicationsOf ResearchDiscoveries

(DARD)

Division ofPrevention and

PopulationSciences (DPPS)

Division ofCardiovascular

Diseases (DCVD)

Office ofBiostatistics

Research (OBR)

3

Investigator-initiated Studies R01 and R21

70% of NHLBI funding is investigator-initiated research ( < 1.515 M DC ) Some examples of studies (titles):

Improving Self-Care Behavior and Outcomes in Rural Patients with Heart Failure

Telemonitoring to Improve Heart Failure Outcomes

Improving Coronary Prevention in a County Health System

4

Conceptualization of Causal Influences for Cardiovascular Disease

Type and quantity of food available

Physical activity opportunities

Tobacco availability

Social/cultural issues: SES, family, workplace

Community Environmental

Factors

Lifestyle Factors

Psychosocial factors

Behavioral Factors

Blood pressure

Blood lipids

Diabetes/insulin resistance

Obesity

Biological Risk Factors

Atherosclerosis

Thrombotic vascular autonomic serotonergic inflammatory immunologic function

Mechanisms Subclinical

Disease

CAD/CHD

Heart failure

Arrhythmias

Sudden cardiac death

Valvular heart disease

Stroke

Clinical Disease

Morbidity

Mortality

Life expectancy

Functioning & quality of life

Health Outcomes

(DSM, 4/06)

TAAG

GEMS

Worksite obesity

HTN control

ACCORD

POWER HF-ACTION

Door to Balloon

PROMIS

Health care system, treatment delivery, access to care

5

Topics Being Addressed in NHLBI QOC and Outcomes Studies

AMI, CHD, and CVD treatment HF management Hypertension control Dyslipidemia treatment Anticoagulation in atrial fibrillation Blood transfusion guidelines Obesity control Lifestyle (diet and physical activity)

6

Determinants and Interventions for QOC &Outcomes: Multi-level Model

(Simons-Morton unpublished, 2005)

Patient Health

Insurance & Government• Performance measures (e.g.,HEDIS)• Accreditation (JCAHO)• Insurance reimbursement (p4p)• Clinical guidelines

Clinical Institutions• CME, academic detailing• Services & appointments• Patient monitoring & feedback• Reminders, charting cues• Provider incentives

Patients• Knowledge• Tx Adherence• ↓Risk Factors

Clinicians• Testing & diagnosis• Treatments & procedures• Advice & counseling• Referrals

Interventions

7

Interventions targeting clinicians and systems

Clinician and staff training Academic detailing Patient chart audit and feedback to

physicians Decision-support tools Clinician incentives Nurse case management Pharmacy-based approaches Telemonitoring

Types of Interventions Tested

8

Trials to improve clinical practice through guidelines (RFA 2002-2007)

11 RCTs testing approaches to improve provider adherence to evidence-based guidelines (HTN, CVD secondary prevention

Weight Loss in Obese Adults with CV RFs: Clinical Interventions (RFA 2006-2011)

3 RCTs testing interventions delivered in routine clinical practice to reduce weight

Examples of NHLBI-initiated QOC & Outcomes Research

9

Interventions addressing patients or patient-provider relationships

Home visits with assessment & counseling

Self-monitoring (e.g., BP monitoring) Patient education & counseling

Interpersonal, e.g., motivational interviewing Media-based, e.g., automated telephone counseling, patient

motivational and educational videos “Patient activation” approaches (e.g.,

waiting room materials)

Types of Interventions Tested – Chronic Care Model

NHLBI Strategic Plan: Future Opportunities for Translation Research

.

June , 2008

11

Goals – embraces Quality and Outcome Research

Goal 3 Generate an improved understanding of the processes involved in translating research into practice and use that understanding to enable improvements in public health and to stimulate further scientific discovery. Cause → Cures

Challenges Relevance to Outcomes Research – the Tent is large

Challenge 3.1.c. Develop and evaluate interventions to improve patient, provider, and health-care system behavior and performance to enhance quality of care & health outcomesChallenge 3.2. Identify cost-effective approaches for prevention, diagnosis, and treatment

13

Strategic Plan Impact

Research examining delivery of clinical care, and testing approaches to improve the quality of care, is extremely important for ultimately improving the public’s health

Pending results from NHLBI studies will have strong implications for future clinical practice

NHLBI has a strong, and increasing, portfolio in CVD QOC & Outcomes research

The NHLBI Strategic Plan provides a blueprint for additional future research

14

Program Directors

Their goal is to help you Lawton Cooper Paula Einhorn Barbara Wells Email with specific aims Go over the summary statement

with them All questions are welcome

15

Awards For Young Awards For Young InvestigatorsInvestigators

Mentored Clinical Scientist Development Mentored Clinical Scientist Development Award (K08)Award (K08)

Mentored Patient-Oriented Research Mentored Patient-Oriented Research Career Development Award (K23)Career Development Award (K23)

Independent Scientist Award (K02)Independent Scientist Award (K02)

NIH Pathway to Independence Award NIH Pathway to Independence Award (K99/R00)(K99/R00)

16

Looking forward to our discussion

17

all slides after this are extra

18

Office of Research Training and Career Office of Research Training and Career DevelopmentDevelopment

Division of Cardiovascular Diseases (DCVD), Division of Cardiovascular Diseases (DCVD), NHLBI, NIHNHLBI, NIH

Jane D. Scott, ScD, MSNJane D. Scott, ScD, MSN Michael Commarato, PhD Michael Commarato, PhD Jamie Varghese-Skipper, PhDJamie Varghese-Skipper, PhD Tawanna Meadows, BSTawanna Meadows, BS DCVD Training 301.435.0535DCVD Training 301.435.0535 Scottj2@nhlbi.nih.govScottj2@nhlbi.nih.gov http://www.nhlbi.nih.gov/funding/training/index.hthttp://www.nhlbi.nih.gov/funding/training/index.ht

mm

http://grants1.nih.gov/training/extramural.htmhttp://grants1.nih.gov/training/extramural.htm http://grants1.nih.gov/training/careerdevelopmenthttp://grants1.nih.gov/training/careerdevelopment

awards.htmawards.htm

19

Independent Scientist Independent Scientist Award (K02)Award (K02)

Investigators at non-federal public or profit U.S. Investigators at non-federal public or profit U.S. institutions engaged and funded in health-institutions engaged and funded in health-related research. related research.

Application deadlines: February 12, June 12, Application deadlines: February 12, June 12, October 12 October 12 (new).(new).

Support: 3-5 years Support: 3-5 years

Salary support only: Up to $75,000 per year Salary support only: Up to $75,000 per year plus benefits. No other research development plus benefits. No other research development support funds are provided.support funds are provided.

20

NewNew NIH Pathway to NIH Pathway to Independence Award Independence Award (K99/R00) PA-06-133(K99/R00) PA-06-133

• Applicants: Postdoctoral candidates who have Applicants: Postdoctoral candidates who have clinical or research doctorates (Ph.D, M.D., D.O., clinical or research doctorates (Ph.D, M.D., D.O., etc.) with no more than 5 years of research training. etc.) with no more than 5 years of research training.

• Requirements: at least 75% effort.Requirements: at least 75% effort.

• Support: 2 years (K99); 3 years (R00); need tenure Support: 2 years (K99); 3 years (R00); need tenure track faculty position. IC review.track faculty position. IC review.

• Salary: Salary: • K99--up to $90,000 per year plus benefits; up to $20,000 K99--up to $90,000 per year plus benefits; up to $20,000

per year for research support; salary limited to $50,000; F per year for research support; salary limited to $50,000; F & A is 8%.& A is 8%.

• R00– up to $249,000 per year plus benefits; full F&A costsR00– up to $249,000 per year plus benefits; full F&A costs

21

NIH Pathway to NIH Pathway to Independence Award Independence Award

(K99/R00)(K99/R00)• Eligible:Eligible:

• Clinical or research doctorateClinical or research doctorate

• No more than 5 years of postdoctoral research trainingNo more than 5 years of postdoctoral research training

• Former principal investigator on R03s, R21s and Former principal investigator on R03s, R21s and SBIRs/STTRsSBIRs/STTRs

• US citizen or non-US citizenUS citizen or non-US citizen

• Not Eligible:Not Eligible:

• Currently or previously held a research faculty positionCurrently or previously held a research faculty position

• More than 5 years of postdoctoral research trainingMore than 5 years of postdoctoral research training

• Have been a principal investigator on NIH research grants Have been a principal investigator on NIH research grants or non-NIH research grants over $100,000 in direct costs or non-NIH research grants over $100,000 in direct costs per yearper year

22

NHLBI Research Training NHLBI Research Training ContactsContacts

K08 – K08 – Mentored Clinical Scientist Development Award Mentored Clinical Scientist Development Award Ms. Lorraine Silsbee (301) 435-0707Ms. Lorraine Silsbee (301) 435-0707

K23 – K23 – Mentored Patient-Oriented Research Career Mentored Patient-Oriented Research Career Development Award Development Award Ms. Ann Rothgeb (301) 435-0202 Ms. Ann Rothgeb (301) 435-0202

K02 – K02 – Independent Scientist AwardIndependent Scientist AwardDr. Traci H. Mondoro (301) 435-0052Dr. Traci H. Mondoro (301) 435-0052

K99/R00 – K99/R00 – Pathway to Independence AwardPathway to Independence AwardDr. Jane Scott (301) 435-0535Dr. Jane Scott (301) 435-0535

K24 – K24 – Patient-Oriented ResearchPatient-Oriented Research AwardAwardDr. Ellen Werner (301) 435-0077Dr. Ellen Werner (301) 435-0077

F33F33 – National Research Service Award for Senior Fellows – National Research Service Award for Senior FellowsDr. Jared Jobe (301) 435-0407Dr. Jared Jobe (301) 435-0407

F32–F32– NRSA Individual Fellowship NRSA Individual FellowshipMs. Tawanna Meadows (301)435-0534Ms. Tawanna Meadows (301)435-0534

23

NewNew Grant Submission Grant Submission DatesDates

Notice Number: NOT-OD-07-001 Notice Number: NOT-OD-07-001

http://grants.nih.gov/grants/guide/notice-fihttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-001.htmlles/NOT-OD-07-001.html

Starts January 2007Starts January 2007

NIH Pathway to Independence NIH Pathway to Independence (PI) Award(PI) AwardK99/R00K99/R00

25

NIH Pathway to Independence (PI) NIH Pathway to Independence (PI) Award (K99/R00)Award (K99/R00)

Up to 5 years support, two phasesUp to 5 years support, two phases Phase I Mentored researchPhase I Mentored research, 1-2 years (K99), 1-2 years (K99) Phase II Independent researchPhase II Independent research support (R00) 1- support (R00) 1-

3 years, contingent on securing an independent 3 years, contingent on securing an independent research positionresearch position

Each phase provides funds for salary & Each phase provides funds for salary & research costsresearch costs

26

K99/R00 Applicant RequirementsK99/R00 Applicant Requirements

Outstanding postdoctoral candidates Outstanding postdoctoral candidates No more than 5 years postdoctoral No more than 5 years postdoctoral research research

trainingtraining US citizens & non-US citizensUS citizens & non-US citizens May submit only one PI Award applicationMay submit only one PI Award application May notMay not simultaneously submit applications or simultaneously submit applications or

have pending awards for any other PHS career have pending awards for any other PHS career development award (no K awards)development award (no K awards)

27

Eligible: Individuals who were PIs on NIH R03, Eligible: Individuals who were PIs on NIH R03, R21, & Phase I SBIR/STTR grantsR21, & Phase I SBIR/STTR grants

Not Eligible: Those who have served as PI on Not Eligible: Those who have served as PI on peer-reviewed non-NIH research grants over peer-reviewed non-NIH research grants over $100K in direct costs per year (awards intended $100K in direct costs per year (awards intended for faculty).for faculty).

EligibleEligible

28

Individuals with current or prior “research faculty” Individuals with current or prior “research faculty” positions or other professorships in academia, positions or other professorships in academia, industryindustry

More than five years of post-doctoral training at More than five years of post-doctoral training at time of initial application or resubmissionstime of initial application or resubmissions

PI on NIH R01, P01, or subprojects of such grantsPI on NIH R01, P01, or subprojects of such grants

PI on an NIH career development award (K award)PI on an NIH career development award (K award)

IneligibleIneligible

29

Total costs/yr may not exceed $90K including Total costs/yr may not exceed $90K including salary, fringe, and up to $20K in “research support salary, fringe, and up to $20K in “research support costs” costs”

Research support includes tuition and fees related Research support includes tuition and fees related to career development, supplies equipment, to career development, supplies equipment, technical personnel, travel to research meetings, technical personnel, travel to research meetings, statistical services and computer timestatistical services and computer time

Salary is limited to $50KSalary is limited to $50K Minimum percent effort is 75%Minimum percent effort is 75% K activities include research, publication, K activities include research, publication, and and

searching for an independent research positionsearching for an independent research position

K99 K99 (Up to 2 years)(Up to 2 years)

30

Total costs per year not to exceed $249,000/yrTotal costs per year not to exceed $249,000/yr Includes salary, fringe, research support Includes salary, fringe, research support

allowance and applicable F&A costsallowance and applicable F&A costs R00 contingent on awardee securing an R00 contingent on awardee securing an

independent tenure-track, full-time assistant independent tenure-track, full-time assistant professor position at an eligible institutionprofessor position at an eligible institution

Salary based on 12 month full-time appointmentSalary based on 12 month full-time appointment Candidates must devote a minimum of 75% time Candidates must devote a minimum of 75% time

to their researchto their research Remaining time “devoted to activities related to Remaining time “devoted to activities related to

the development of a successful research career”the development of a successful research career”

R00 R00 (up to 3 years)(up to 3 years)

31

Current StatusCurrent Status

First study section review November 2006First study section review November 2006 78 grants received first 2 cycles, 36 scored, 42 78 grants received first 2 cycles, 36 scored, 42

streamlinedstreamlined First awards made December 2006First awards made December 2006 NHLBI funded 19 (11 DCVD)NHLBI funded 19 (11 DCVD) Review & approval procedures for transition from K to R Review & approval procedures for transition from K to R

being developed. being developed. K99 grants are assigned to training program officers, K99 grants are assigned to training program officers,

R00 grants will transition to appropriate DCVD R00 grants will transition to appropriate DCVD branchesbranches

Screening for eligible candidates has been difficultScreening for eligible candidates has been difficult Screening by committeeScreening by committee

32

K99/R00 LinksK99/R00 Links

PA-06-133:PA-06-133:

http://grants.nih.gov/grants/guide/pa-files/PA-06-http://grants.nih.gov/grants/guide/pa-files/PA-06-133.html133.html

Questions and Answers Questions and Answers http://http://grants.nih.gov/grants/new_investigators/QsandAsgrants.nih.gov/grants/new_investigators/QsandAs.htm.htm

Backgrounder Backgrounder http://http://grants.nih.gov/grants/new_investigators/backgrogrants.nih.gov/grants/new_investigators/backgrounder.htmunder.htm

33

DCVD Office of Research DCVD Office of Research Training & Career Training & Career

DevelopmentDevelopment

Jane D. Scott, ScD, MSNJane D. Scott, ScD, MSN

Michael Commarato, PhDMichael Commarato, PhD

Drew Carlson, PhDDrew Carlson, PhD

Tawanna Meadows, BSTawanna Meadows, BS

301.435.0535301.435.0535

34

Types of Studies Funded/sponsored

Focus on obtaining evidence base for clinical and public-health practice

Research questions – continuums from prevention to treatment efficacy (“ideal settings”) to effectiveness (“real world”

settings)

Intervention studies – RCTs, the most valid approach to determine effects of interventions

Large studies often needed to answer questions Portfolio of smaller studies – investigator-initiated

and targeted topics

35

Goals, Challenges & Strategies

NHLBI Strategic Plan has Three Goals, each Goal further defined by Challenges

To guide implementation, the Strategic plan has Eight Strategies, which will change as Challenges are met and new Challenges emerge

36

Phase 2 Translation Research: Rationale

Efficacy of certain treatment and prevention approaches has been established.

What we know is not always translated into clinical practice; there are many disparities.

Traditional approaches to translation are only partially effective (e.g., CME, publications).

Additional research is needed examining factors that affect care delivery and testing interventions to improve quality of care across a broad spectrum of delivery settings and populations.

37

NHLBI “Working Group on CVD Outcomes Research” (Jan 2004)

Working Group Recommendations National surveillance of CV care and outcomes Focus on patient-centered care (e.g., QOL,

patient decision-making) Study patient adherence and self-management Evaluate efficacy and effectiveness of therapies

in “real-world” settings Test interventions to improve provider delivery

of effective therapies Conduct economic evaluations

Krumholz et al, Circulation, 2005

38

Improving Hypertension Control Among Inner City Minorities (RFA 1993-1997)

Feasibility, acceptability, and effectiveness of programs to detect & control HTN in inner-city minority groups

Overcoming Barriers to Tx Adherence in minorities & persons living in poverty (RFA 2001-2007)

13 RCTs testing innovative, practical interventions to improve adherence in disadvantaged groups

Examples of NHLBI-initiated QOC & Outcomes Research

39

Examples of NHLBI-initiated QOC & Outcomes Research

Cardiovascular Research Network (CVRN) (RFA 2007-2012)

Infrastructure for CVD research in community-based healthcare – clinical epidemiology, health services research, etc.

Improving HF Disease Management (PA 2007)

Research to address unanswered questions about Dz management approaches for HF

40

Strategic Plan Challenge 3.3

Challenge 3.3To promote the development and implementation of evidence-based guidelines in partnership with individuals, professional and patient communities, and health care systems and to communicate research advances effectively to the public.

41

Office of the DirectorMichael Lauer, M.D., Director

Diane Bild, M.D., M.P.H., Deputy DirectorDenise Simons-Morton, M.D., Ph.D., Senior

Advisor

Clinical Applications and Prevention Branch (CAPP) Lawrence Fine, M.D., Dr.P.H.

Chief

Epidemiology Branch (EBP)Paul Sorlie, Ph.D.

Chief

Women’s Health Initiative Branch

Jacques Rossouw, M.D.Chief

Division of Prevention and Population Sciences

DPPS supports and provides leadership for population- and clinic-based research:

•on the causes, prevention, and clinical care of cardiovascular, lung, and blood diseases and sleep disorders. • epidemiological studies to describe disease and risk factor patterns in populations and to identify risk factors for disease; •clinical trials of interventions to prevent disease; •studies of genetic, behavioral, sociocultural, and environmental influences on disease risk and outcomes; and •studies of strategies to improve clinical care and public health.

42

Age-Adjusted Death Rates for Coronary Heart Disease, U.S., 1950-2004

U.S. Actual

U.S. "Could Be"(Based on Japan Actual)

1980Year

400

300

200

100

0

Deaths/100,000 Population

500

600

197019601950 1990 2000 2010

43

The proposed SPRINT trial is designed to determine whether treating systolic blood pressure to the lower goal of less than 120 mm of Hg rather than the currently recommended goal of less than 140 mm of Hg reduces CVD morbidity/mortality in high risk adults. The trial will have 7500 participants who have an initial systolic blood pressure of 130 mm of Hg or above.

44

NHLBI Many Partnerships

.

ResearchersInternation

alOrganizatio

ns

Federal-State-LocalAgencies

Corporations

Foundations

CommunityOrganizatio

ns

PatientAdvocacyGroups

Voluntary Health

Organizations

Professional

Societies

45

0

50

100

150

200

250

300

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Fiscal Year

# o

f A

pp

lica

tio

ns

K23

K08

*

NHLBI K08 and K23 Applications Fiscal Years 1995 - 2005

46

Trends in Number of Individual Trends in Number of Individual K K Awards by Awards by Institute or CenterInstitute or Center

Fiscal Years 1995 - 2005Fiscal Years 1995 - 2005

0

100

200

300

400

500

600

Excludes K12, K16, and K17.

47

Research Training & Career Development Research Training & Career Development Opportunities, NHLBI, DCVDOpportunities, NHLBI, DCVD

HSHS

&&

CollegeCollege

Graduate &Graduate &

Medical Medical SchoolSchool

Post graduate Post graduate FellowshipsFellowships

Transition to Transition to

Established Established InvestigatorInvestigator

Established Established

InvestigatorInvestigator

MARC MARC U*STARU*STAR

UndergradsUndergrads

BRTPUGBRTPUG

ProgramProgram

Undergrads, Undergrads, post-bac, &post-bac, &

graduates graduates

T35 T35

UndergradsUndergrads

BRTPUG Prgm.BRTPUG Prgm.

T32 InstitutionalT32 Institutional

AwardAward

T32 T32

Minority InstitutionsMinority Institutions

F31F31

Minority students & Minority students & individuals with individuals with

disabilitiesdisabilities

T35 T35

Minority studentsMinority students

T32 T32

Institutional AwardInstitutional Award

T32 T32

Minority Institution Minority Institution AwardAward

F32 F32

Individual awardIndividual award

K08K08

K23K23

K25K25

K02K02

K01 Minority K01 Minority

FacultyFaculty

K01 Minority K01 Minority

InstitutionInstitution

K99/R00K99/R00

F33F33

K24K24

K25K25

48

Number of NIH Number of NIH KK Awards AwardsFiscal Years 1995 - 2005Fiscal Years 1995 - 2005

1,500

2,000

2,500

3,000

3,500

4,000“Patient-Oriented Research” awards begin

49

PurposePurpose

T32 Program UpdateT32 Program Update DiscussionDiscussion SuggestionsSuggestions QuestionsQuestions

50

Mentored Clinical Mentored Clinical Scientist Development Scientist Development

Award (K08)Award (K08) Applicants: Clinicians who are interested Applicants: Clinicians who are interested

in developing independent research in developing independent research careers. careers.

Requirements: at least 75% effort.Requirements: at least 75% effort.

Support: 3-5 years.Support: 3-5 years.

Salary: Up to $75,000 per year plus Salary: Up to $75,000 per year plus benefits and up to $25,000 per year for benefits and up to $25,000 per year for research development support.research development support.

51

Mentored Patient-Oriented Mentored Patient-Oriented Research Career Research Career DevelopmentDevelopment

Award (K23)Award (K23)

Applicants: Scientists who are committed to Applicants: Scientists who are committed to developing careers in patient-oriented developing careers in patient-oriented research. research.

Requirements: at least 75% effort.Requirements: at least 75% effort.

Support: 3-5 years.Support: 3-5 years.

Salary: Up to $75,000 per year plus benefits Salary: Up to $75,000 per year plus benefits and up to $50,000 per year for research and up to $50,000 per year for research development support.development support.

52

Similarities Similarities betweenbetween K08 & K23 K08 & K23 AwardsAwards

Mentored research awardsMentored research awards Faculty appointment not required Faculty appointment not required Require Require >> 75% effort 75% effort 3 – 5 years of support3 – 5 years of support Budgets similarBudgets similar

Salary levels vary by NIH instituteSalary levels vary by NIH institute

53

Differences between K08 & K23Differences between K08 & K23

Research Development Support -Research Development Support -

$25,000/year for K08$25,000/year for K08

Up to $50,000/year for K23Up to $50,000/year for K23 K23 candidates:K23 candidates:

mustmust take courses such as study design, take courses such as study design, biostatistics, epidemiology, data management, biostatistics, epidemiology, data management, hypothesis development, drug development, hypothesis development, drug development, etc.etc.

mustmust complete courses on the legal and complete courses on the legal and ethical issues associated with the safe ethical issues associated with the safe conduct of human subjects researchconduct of human subjects research

54

K08 & K23 Pilot ProgramK08 & K23 Pilot Program

K Awards have required 75% effort, 3-K Awards have required 75% effort, 3-5 years5 years

Starting 2006, a new trial will permit Starting 2006, a new trial will permit 50% research effort for the duration of 50% research effort for the duration of a K grant for selected sub-specialists a K grant for selected sub-specialists including: cardiothoracic surgeons, including: cardiothoracic surgeons, vascular surgeons, and interventional vascular surgeons, and interventional cardiologists cardiologists

55

What is “Patient-Oriented What is “Patient-Oriented Research”?Research”?

Research conducted with human subjects Research conducted with human subjects (or on material of human origin such as (or on material of human origin such as tissues, specimens, and cognitive tissues, specimens, and cognitive phenomena) for which an investigator phenomena) for which an investigator directly interacts with human subjects.directly interacts with human subjects. mechanisms of human diseasemechanisms of human disease therapeutic interventionstherapeutic interventions clinical trialsclinical trials development of new technologiesdevelopment of new technologies

56

What Doesn’t Count What Doesn’t Count as Patient-Oriented Research?as Patient-Oriented Research?

Analysis of existing databasesAnalysis of existing databases Brief interaction with human subjects (such as one Brief interaction with human subjects (such as one

blood draw)blood draw) Candidate designs a questionnaire that will be Candidate designs a questionnaire that will be

administered by other staffadministered by other staff These projects are appropriate for K08 mechanismThese projects are appropriate for K08 mechanism