Multidisciplinary Clinical Research Career Development Program (MCRCDP) An Overview

Multidisciplinary Clinical Research Career Multidisciplinary Clinical Research Career Development Program (MCRCDP)Development Program (MCRCDP)

An OverviewAn Overview

Eugene P. Orringer, MD, Professor of Medicine

& Executive Associate Dean for

Faculty Affairs and Faculty Development

UNC School of Medicine

UNC Multidisciplinary Clinical Research UNC Multidisciplinary Clinical Research Career Development ProgramCareer Development Program

Leadership of the UNC ProgramLeadership of the UNC Program

• Eugene Orringer, MD Principal Investigator

• Morris Weinberger, PhD Co-Principal Investigator

• Susan Pusek, MPH Education Champion

• Bill Miller, MD-PhD Curriculum Director

• Rosalie Dominik, DrPh Director, Biostatistics Core

• Tricia Byrns, MD Program Evaluation

• Alison Regan Financial Manager

• Lowell Goldsmith, MD Program Ombudsman

Multidisciplinary Clinical Research Multidisciplinary Clinical Research Career Development Program Career Development Program

An NIH Roadmap InitiativeAn NIH Roadmap Initiative

NIH Roadmap

• Dr. Elias Zerhouni initiated the NIH Roadmap Program soon after he assumed the NIH Directorship in 2002

• The Roadmap was designed to identify opportunities and gaps in biomedical research that no single institute at NIH could tackle alone, but that the agency as a whole needed to address.

• Dr. Zerhouni argued that NIH is uniquely positioned to catalyze the changes that must be made if we are to transform new scientific knowledge into tangible benefits for people.

NIH Roadmap

UNC has been a major beneficiary of the Roadmap. Through the end of FY 2006, UNC had received more Roadmap awards than any other single institution.

» 6 Roadmap Awards in 2004



NIH Roadmap Data

YEARTotal # of Roadmap Awards

# Institutions Receiving Roadmap Awards

# of States Receiving Roadmap Awards

# of Roadmap Awards

Received by UNC

% of Roadmap Awards Made

to UNC

2004 193 96 29 6 3.1

2005 186 91 30 8 4.3

2006 178 109 38 11 6.2

Data for Data for 2004-20062004-2006 557557 177177 4040 2525 4.54.5

The NIH RoadmapThe NIH Roadmap

Re-engineering theClinical Research Enterprise

Research Teamsof the Future

New Pathways to Discovery

Multidisciplinary Clinical Research Career Multidisciplinary Clinical Research Career Development ProgramDevelopment Program

• The MCRCDP was created as a key component of the NIH Roadmap. It was specifically designed to help

Re-engineer the Clinical Research EnterpriseRe-engineer the Clinical Research Enterprise

Research Teams of the FutureResearch Teams of the Future

• The MCRCDP has been funded using the

K12 mechanismK12 mechanism

Multidisciplinary Clinical Research Multidisciplinary Clinical Research Career Development ProgramCareer Development Program

What is a K12 Award?What is a K12 Award?

• A K12 Award is a grant to an institution that is designed to provide protected time to a group of scientists committed to academic research careers.

• A K12 Award is very much like a training grant (i.e., a T32), but one that is designed for more senior level post-doctoral fellows and especially for junior faculty

Number of Training AwardsUniversity T32s K12s

Michigan 70 3

UNC-Chapel Hill 53 61/2

UCSF 50 5

Wisconsin 43 4

Duke 40 51/2

Wash U 33 5

UAB 27 3

Virginia 24 1

UNC BIRCWH Program

Building

Interdisciplinary

Research

Careers in

Women’s

Health

UNC BIRCWH Program

• UNC BIRCWH K12 Award began in September 2000

• This Grant brought us 5 years of NIH funding at $500,000/year

• The vast majority of these $’s have been used to provide salary support to junior faculty members in exchange for 75% protected research time

• Based on the success of our program, we were able to compete successfully for a renewal of the

BIRCWH Award in September 2005


When was the MCRCDP first established?When was the MCRCDP first established?

• The original RFA for this program was announced in late 2003 & a second RFA was published by the NIH in late 2004

• The initial group of awards was made in the summer of 2004 & the second group of awards was made in the summer of 2005

Multidisciplinary Clinical Research Career Multidisciplinary Clinical Research Career Development ProgramsDevelopment Programs

What institutions were able to compete What institutions were able to compete successfully for MCRCDPs?successfully for MCRCDPs?

Programs funded in 2004Programs funded in 2004

• UCSF

• Mayo Clinic

• Case WR - Cleveland Clinic

• Johns Hopkins

• University of Washington

• University of Wisconsin

• University of Pittsburgh

Programs funded in 2005Programs funded in 2005

• University of Minnesota

• Washington University

• UT - Southwestern

• University of Maryland

• UNC - Chapel Hill

Multidisciplinary Clinical Research Career Multidisciplinary Clinical Research Career Development ProgramsDevelopment Programs

What has happened since the creation of the MCRCDPs?

Establishment of the

Clinical & Translational Science Awards

(CTSA)

Primary Objective of the CTSA Program: Primary Objective of the CTSA Program: Speed Discoveries that will Improve Patient CareSpeed Discoveries that will Improve Patient Care

• Develop a distinct discipline for clinical & translational science at institutions across the country

• Provide opportunities and resources for original research on novel methods

• Develop translational technologies & a knowledge base for the full spectrum of clinical and translational science

• Synergize partnerships with industry, foundations, and community physicians

• Train the multidisciplinary teams that will conduct Train the multidisciplinary teams that will conduct the clinical and translational research of the futurethe clinical and translational research of the future

Clinical and Translational Science Awards (CTSAs)Clinical and Translational Science Awards (CTSAs)

Lower barriers between disciplines

Encourage creative, innovative approaches in solving complex medical problems

Catalyze change: break silos, barriers, and conventions

NIH CTSA AwardsNIH CTSA AwardsA Home for Clinical and Translational ScienceA Home for Clinical and Translational Science

Trial DesignTrial Design

AdvancedAdvanced Degree-GrantingDegree-Granting

ProgramsPrograms

ParticipantParticipant& Community& CommunityInvolvementInvolvement

RegulatoryRegulatorySupportSupport

Biostatistics

ClinicalClinicalResourcesResources

BiomedicalBiomedicalInformaticsInformatics

ClinicalResearch

Ethics

CTSACTSAHOMEHOME

NIHNIH

OtherOtherInstitutionsInstitutions

IndustryIndustry

Multidisciplinary Clinical Research Multidisciplinary Clinical Research Career Development ProgramsCareer Development Programs

• One of the key features of competing successfully for a CTSA award is the establishment of an Education, Training, & Career Development Program

• A K12 Program like the one described here is essential if a CTSA is to be successful


How is the MCRCDP structured?

• Each program includes: a) a well-designed, didactic, educational core component; b) a practical, hands-on, mentored clinical research component; and c) a shared clinical research support facility

• Together, these three components are designed to provide CR Scholars with a broad experience in all aspects of the design, conduct, and analysis of clinical research

What is meant by Clinical Research?What is meant by Clinical Research?

In this K12 Program, clinical research has been defined to include the following areas:

1.1. Patient oriented researchPatient oriented research: Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects. This area of research includes:

• Mechanisms of human disease

• Therapeutic interventions

• Clinical trials

• Development of new technologies

• Translational research

2.2. Epidemiologic and behavioral researchEpidemiologic and behavioral research

3.3. Health services and outcomes researchHealth services and outcomes research


What is meant by multidisciplinary?Each program is expected to include representatives from multiple clinical disciplines and other professions. Examples include:

• Clinical doctoral degrees such as M.D., D.O., D.D.S., D.M.D., D.V.M., O.D., D.C., Pharm.D., N.D. with various specialties and subspecialties

• Non-clinical doctoral degrees such as DPH, Ph.D., Sc.D., EdD from a wide variety of disciplines.

How does multidisciplinary differ How does multidisciplinary differ from interdisciplinary ?from interdisciplinary ?

• A multidisciplinarymultidisciplinary approach brings together numerous experts from diverse disciplines to collectively address a complex problem, with each expert addressing the issues from the perspective of his or her own discipline.

• An interdisciplinaryinterdisciplinary approach results from the melding of two or more disciplines to create a new (i.e., interdisciplinary) science. Biostatistics, bioinformatics, bioengineering, and psychoneuroimmunology are but a few examples of existing interdisciplinary sciences.

Multidisciplinary Clinical Research Multidisciplinary Clinical Research Career Development ProgramCareer Development Program

What are the overall objectives of this Program?What are the overall objectives of this Program?

• Stimulate multidisciplinary clinical research training and education

• Enhance career development of postdoctoral fellows and junior faculty from multiple disciplines, specialties and

subspecialties

• Establish a critical mass of national programs with a commitment to the development of a diverse, well-integrated, multidisciplinary workforce


The UNC ProgramThe UNC Program

Based in all of the Schools on the Health Affairs Campus(Medicine, Public Health, Nursing, Dentistry, Pharmacy)

Our Goals

• Select as Scholars both senior fellows and junior faculty

• Train these Scholars at a relatively early stage of research career

• Have a minimum of 3 disciplines represented each year

• Do our best to have all 5 schools represented within the program

• Recruit both women and underrepresented minorities

• Recruit both locally & nationally: Make the program a national resource


Why was UNC selected receive this award?Why was UNC selected receive this award?

• Strong, well-established research programs based in each of the five schools on a single, contiguous Health Affairs campus

• Long history of multidisciplinary collaboration

• Great success with multidisciplinary Centers, Institutes, Programs

• Excellent experience at UNC with the RWJ Clinical Scholars Program as well as with our K30 & several other NIH-funded K12 Programs

• Well-established partnerships with public and private sector entities (e.g., Glaxo, Icagen, NIEHS, Quintiles, RTI)

• Passionate commitment to the career development of junior investigators


Leadership of the UNC ProgramLeadership of the UNC Program

• Eugene Orringer, MD Principal Investigator

• Morris Weinberger, PhD Co-Principal Investigator

• Susan Pusek, MPH Education Champion

• Bill Miller, MD-PhD Curriculum Director

• Rosalie Dominik, DrPh Director, Biostatistics Core

• Tricia Byrns, MD Program Evaluation

• Lowell Goldsmith, MD Program Ombudsman


Multidisciplinary Advisory Committee (MAC)

Made up of senior investigators from all five of the Schools on the Health Affairs campus (over 15 disciplines represented)

Regular MAC Meetings - Responsibilities include:

• Scholar selection

• Review, monitor and recommend changes in curriculum

• Monitoring and evaluation of the progress of each Scholar

• Monitoring and evaluation of the effectiveness of the program

What comes with support from the MCRCDP?

• Support for salary: starting in 2007, this is 75% salary support up to $75,000 plus fringe benefits

• Support for research activities, travel, tuition and fees, books: up to $25,000/year

• Support for Mentors: $5,000/year for as many as two mentors per scholar

• Support from the Shared Biostatistical Core Facility


What are our overall recruitment efforts?What are our overall recruitment efforts?

• In July 2006 we recruited our first 6 Scholars

• In July 2007 we recruited 5 more Scholars

• In July 2008, we anticipate adding 5-6 additional Scholars

• Our goal is to recruit both: Junior Faculty Members Senior Fellows (should be close to getting a faculty position)

• We intend to recruit Scholars from UNC & from outside UNC

• In all cases, there must be a commitment for a faculty position from the Chair of the relevant Department



The website for the MCRCDP is:

www.med.unc.edu/orfd/career-development-1/k12-roadmap

The e-mail address for the MCRCDP is:

[email protected]@med.unc.edu

Documents

Multidisciplinary Clinical Research Career Development Program (MCRCDP) An Overview