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1
Harvard Postgraduate Educational Program in Clinical/Translational Science
Presentation to ETEC May 6, 2009
2
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
3
* 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
4
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
5
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
6
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
7
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
8
9Westfall JAMA 297: 403,2007
Sung JAMA 289: 1278,2003
10
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)
11
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
13
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)
14
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
15
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
16
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)
17
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
18
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)
19
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
20
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
21
Programs to Support Mentors and Established Investigator
(Research Management, Team Leadership)
For example: Mentoring Training
22
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
23
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)