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Harvard Postgraduate Educational Program in Clinical/Translational Science

Presentation to ETEC May 6, 2009

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The problem….

Eager fellows and Jr Faculty interested in Clinical/Translational Research at Harvard

Institutions

Variation in :

Interests

Experience

Skill Sets

Awareness of Available Resources

Mentoring Relationships

Labs

Courses

Degree Programs

Fuzzy, near random interface

with current training

opportunitiesMD

Collaborative C/T Res Personnel (e.g. RN, CRA,

Data Mgr, Biostatistician etc)

Resources available at

HarvardPhD

Scientist

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* Development of Novel Clinical and Translational Methodologies * Pilot and Collaborative Translational and Clinical Studies * Biomedical Informatics * Research Design, Epidemiology, Biostatistics and Clinical Research Ethics * Regulatory Knowledge and Support * Participant and Clinical Interactions Resources * Community Engagement and Research * Translational Technologies and Resources * Research Education, Training and Career Development * Evaluation

* One or more graduate degree-granting and post graduate programs * Promote recruitment, training, advancement, and retention of new investigators * Permeate all aspects of CTSA program * K12 (KL2) Mentored Career Development Component--Required * T32 (TL2) Institutional Research Training--Optional * Novel Research Education Programs--Encouraged * Multidisciplinary

www.ctsaweb.org

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T32 (TL1)14 slots /yr

PhD Students in Leder Human Biology(Track in BBS)

K12 (KL2)6-7 slots/yr (Avg 2.5 yrs)

Beginning Jr Faculty (75% FTE)Individualized High-End Mentoring in C/T Training

K-3012-15 slots /yr

Scholars in Clinical ScienceTuition Support (Fellows)

Funded FromCatalyst

Clinical/Translational Training Funded by Catalyst (Current)

ScholarsClin Sci

Clin InvTraining

BioInformatics ClinEffectiveness

(HSPH)

GlobalHealth

(HMS/HSPH)

HMS Prime

Overview of Current/Planned Masters Programs in C/T Science

Currently funded

by CatalystBBS Virology Immunology Neuroscience

PhD ProgramsDiv Med Sci

HMS

Biophysics SystemsBiology

ChemicalBiology

Harv Univ-widePhD Programs

Basic Biomedical Science at HMS

Scholars in Medicine--HMS w Scholarly Project

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Clinical/Translational Research Education Oversight (Current)

MGH BWH CHMC BIDMC

DirectorsClin + Trans Ed

MGH BWH CHMC BIDMC Quadrangle

DirectorsClin + Trans

"Studies"(Training + Career Development)

Jr FacultyMentoring

Clin ResTraining-HOSPITALS

(Fellows,Jr Faculty)

CATALYST

HarvardUniversity

Compendium of Current Courses

Assembled

White Paper Drafted on Issues

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Overview of Reorganization of Training in Clinical/Translational Research at Harvard

Biomedical Research Prior to Threshold for Human

Interface

Biomedical Research That Has Arrived at Threshold for Human

Interface

Continuum of Training in C/T Research at Harvard

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Core Competencies in Clinical/Translational Research

• Biostatistics

• Bioethics

• Clinical Trials Design

• Informatics

• Health Data Standards

• Federal Human Research Policies

• Scientific Writing

• Team Leadership

• Preparation for Grant Applications

• Study Design and Assessment • BioStatistics • Clinical Trials and Data

Management • Ethics• Human Subjects Research

Protection• Informed Consent• Scientific Writing• Poster and Oral Presentations• Grantwriting• Drugs and Devices

CTSA RFA RM-09-004 Catalyst ETEC Group White Paper Feb 2009

Additions: Genetics, Management of Research Resources

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9Westfall JAMA 297: 403,2007

Sung JAMA 289: 1278,2003

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Proof of Concept

(T1)

Change Clinical Practice

(T2)

Basic Biomedical

Research That Has Arrived at Threshold for

Human Investigation

Harvard Postgraduate Educational Program in Clinical/Translational Science

Track Careers of C/T InvestigatorsMD

PhDScientists

Collab C/T Res

Personnel

PracticeBased

Research(T3)

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Overview of Vision for Clinical/Translational Res. Ed under Catalyst:Creation of a Harvard Postgraduate Education Program in Clinical/Translational Science

Spectrum of Training Across Clinical Research Continuum

Proof of Concept

(T1)

Change Clinical Practice

(T2)

Range of Learner Needs

and Interests

Intro

ductory

Advance

d

Scope

of M

ater

ial

Biostatistics/Epidemiology/Research Design

Special Methods: eg. Lab/Genetics/Imaging/InformaticsResearch Ethics and Regulatory Knowledge/Resources

Basic Biomedical

Research That Has Arrived at Threshold for

Human Investigation

Translation From Basic Science to Human Studies

Translation of New Knowledge into Clinical

Practice and Health Decision Making

Communications (Oral, Written)

PracticeBased

Research(T3)

Translation of Discoveries

to Care of Patients

12Spectrum of Educational Needs

Proof of Concept

Change Clinical Practice

Intro

ductory

Advance

d e.g.AdvancedImaging

e.g. Training in Genetics Based Research

Examples of Current High-Quality But Largely Uncoordinated Training Efforts:

Biostatistics/Epidemiology/Research Design

Research Ethics and Regulatory Knowledge

Communications (Oral, Written)

Special Methods: eg. Lab/Genetics/Imaging/Informatics

PracticeBased

Research

Overview of Vision for Clinical/Translational Res. Ed under Catalyst:Creation of a Harvard Postgraduate Education Program in Clinical/Translational Science

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Introductory(Trainees/Jr Faculty

who want to do clin res)

Advanced (To Prepare Investigators

for Writing and conducting a Clin Trial)

Masters in Med Science(Preparation for Career

in Clin Res)

Nano Short LongitudinalOther Training Experiences

Courses

Programs to Support Mentors and Established Investigator

(Research Management, Team Leadership)

Emphasize Archiving Of Course Material on Web-Based Platform (e.g. HMS MyCourses)

Overview of Vision for Clinical/Translational Res. Ed under Catalyst:Creation of a Harvard Postgraduate Education Program in Clinical/Translational Science

Programs for K Awardees

(KL2 CTSA req)

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Overview of Vision for Clinical/Translational Res. Ed under Catalyst:Creation of a Harvard Postgraduate Education Program in Clinical/Translational Science

Introductory(Trainees/Jr Faculty

who want to do clin res)

Advanced (To Prepare Investigators

for Writing and conducting a Clin Trial)

Masters in Med Science(Preparation for Career

in Clin Res)

Bioinformatics MabGenotyping ProteomicsStem Cells

Advanced Training in Specialty Cores

Certificate Certificate Masters

Trainees/Jr Faculty at Harvard

HMS Prime

For example:

etc

Harv College, HMS Undergraduates Wishing

to Attend Lectures

Basic Biomedical PhD Training

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Overview of Vision for Clinical/Translational Res. Ed under Catalyst:Creation of a Harvard Postgraduate Education Program in Clinical/Translational Science

Integrated Ongoing Support For Investigators

Trainees/Jr Faculty at Harvard

HMS Prime

Intake and Triage Service

Introductory(Trainees/Jr Faculty

who want to do clin res)

Advanced (To Prepare Investigators

for Writing and conducting a Clin Trial)

Masters in Med Science(Preparation for Career

in Clin Res)

Consultative Cores:Biostatistical

GeneticsImaging

Mentoring + Professional Development

ResearchResources

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Overview of Vision for Clin Res Ed under Catalyst:Creation of a Harvard Postgraduate Educational Program in Clinical/Translational Science

Introduction to Clin Inv Training

Advanced Training in Specialty Cores

Core Knowledge of Clin Res:Statistical Reasoning,Study Design,

Statistical Methods, Threats to Validity(Endpoint selection, collection, analysis)

Human/Regulatory Interface

IRB,HIPAA,Ethics, GCPRegulatory Approval: Drugs, Devices, Biologics

Communication

Written (Ms)Oral (Presentation)

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Day 1 Day 2 Day 3 Day 4 Day 57:30- 8 AM Orientation

8-9 AM Statistical Reasoning

Ethics of Human Investigation

Behav/Soc Sci Research Clin Pharm

Obtaining Consent (Bok Theater Players)

9-10 AM Study Design

Regulatory Considerations Database Res Genetics

How to Deliver Oral Presentation (Harv School of Ed)

10-11 AMStatistical Methods FDA: Drugs

Community Based Participatory Research Imaging

How to Write a Scientific Paper (NEJM, Science)

11-12 NoonThreats to Validity FDA: Devices Lecture Informatics How to Write a Grant

12-1 PM LUNCH LUNCH LUNCH LUNCH LUNCH

1-2:30 PMWorkshop: T1 case

Good Clinical Practice in Research

Workshop: T2/3 Epi Case

Management of Research Resources

Next Steps for Using Lessons Learned:Resources at Catalyst and Harvard Institutions

2:30-4 PM Workshop: T2 case

Workshop: Ethics Cases

Workshop: T3 Hlth Care Deliv Case

Workshop: Mentoring

Introduction to Clin Inv Training

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Overview of Vision for Clinical/Translational Res. Ed under Catalyst:Creation of a Harvard Postgraduate Education Program in Clinical/Translational Science

Advanced Clin Res Training

Advanced Training in Specialty Cores

Adv Biostat + Clin Res Methods(e.g. nanocourses,

HSPH summer clin effect.)

Laboratory Methods(Biomarkers, -omics)

GeneticsPharmacogenomics

Imaging(Clinical, ex vivo)

Epidemiology(Health Care Delivery,Community Interface)

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Overview of Vision for Clinical/Translational Res. Ed under Catalyst:Creation of a Harvard Postgraduate Education Program in Clinical/Translational Science

Masters in Med Science

Advanced Training in Specialty Cores

ScholarsClin Sci

Clin InvTraining

BioInformatics ClinEffectiveness

(HSPH)

GlobalHealth(HSPH)

HMS Prime

K12 (KL2) for Jr Faculty(CTSA req)

Other K Award Programs

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Overview of Vision for Clinical/Translational Res. Ed under Catalyst:Creation of a Harvard Postgraduate Education Program in Clinical/Translational Science

Proof of Concept

Change Clinical Practice

PracticeBased

Research

Masters in Med Science(Proposal for New Model)

HMS Prime

Bioinformatics

CITP

Scholars

Clin Effect

Global Health

Creat

ion o

f

Shared

Cours

es:

Ethic

s, G

CP,

Reg

Knowle

dge

Shared

Public

ity a

bout

Progra

ms

and

Applicat

ion P

roce

ss

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Programs to Support Mentors and Established Investigator

(Research Management, Team Leadership)

For example: Mentoring Training

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Harvard Postgraduate Education Program

in Clinical/Translational Science

Rough Draft of IT Needs

Input Content

Create Algorithm for User Query of

Content of Program

Sort Content Based on

Query

Intro, Adv, Masters, K12 etc

Topics: Biostat, Genetics, etc

Archive Content

Registrar

Functions

Major Categories of Informatics Needs:

1. Searchable catalog

2. Content Management

3. Registrar/Administrative Functions

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Harvard Postgraduate Education Program

in Clinical/Translational Science

Governance

• TBN• Director--Antman• Administrator**• Asst. Admin • Other

“Cabinet” Level 1(q 2-4 wks)

Advisory Board

*FunctionsRegistrarCertificationSchedulingITFaculty Interface

Administration*

**Knowledge SetScientific Experience

(preferably in clin res)Organizational experienceLeadership experienceCross Cutting experienceDegree: PhD or Masters

• Antman• Ware• Golan• TBN

• TBN

“Cabinet” Level 2(Q 6-8 wks)