1. 1 Harvard Postgraduate Educational Program in Clinical/Translational Science Presentation to ETEC May 6, 2009

2. 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 opportunities MD Collaborative C/T Res Personnel (e.g. RN, CRA, Data Mgr, Biostatistician etc) Resources available at Harvard PhD Scientist

3. 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. 4 Clinical/Translational Training Funded by Catalyst (Current) HMS Prime Overview of Current/Planned Masters Programs in C/T Science Currently funded by Catalyst Basic Biomedical Science at HMS Scholars in Medicine-- HMS w Scholarly Project

5. 5 Clinical/Translational Research Education Oversight (Current) Compendium of Current Courses Assembled White Paper Drafted on Issues

6. 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. 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-09-004Catalyst ETEC Group White Paper Feb 2009 Additions: Genetics, Management of Research Resources

8. 8

9. 9 Westfall JAMA 297: 403,2007 Sung JAMA 289: 1278,2003

10. 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 Investigators MD PhD Scientists Collab C/T Res Personnel Practice Based Research (T3)

11. 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 Introductory Advanced Scope of Material Biostatistics/Epidemiology/Research Design Special Methods: eg. Lab/Genetics/Imaging/Informatics Research 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) Practice Based Research (T3) Translation of Discoveries to Care of Patients

12. 12 Spectrum of Educational Needs Proof of Concept Change Clinical Practice Introductory Advanced e.g. Advanced Imaging 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 Practice Based Research Overview of Vision for Clinical/Translational Res. Ed under Catalyst: Creation of a Harvard Postgraduate Education Program in Clinical/Translational Science

13. 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 Longitudinal Other 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. 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) BioinformaticsMabGenotypingProteomicsStem Cells Advanced Training in Specialty Cores 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. 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 Genetics Imaging Mentoring + Professional Development Research Resources

16. 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

17. 17 Introduction to Clin Inv Training

18. 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

19. 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 HMS Prime K12 (KL2) for Jr Faculty (CTSA req) Other K Award Programs

20. 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 Practice Based Research Masters in Med Science (Proposal for New Model) HMS Prime Bioinformatics CITP Scholars Clin Effect Global Health Creation of Shared Courses: Ethics, GCP, Reg Knowledge Shared Publicity about Programs and Application Process

21. 21 Programs to Support Mentors and Established Investigator (Research Management, Team Leadership) For example: Mentoring Training

22. 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. 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 *Functions Registrar Certification Scheduling IT Faculty Interface Administration* **Knowledge Set Scientific Experience (preferably in clin res) Organizational experience Leadership experience Cross Cutting experience Degree: PhD or Masters Antman Ware Golan TBN “Cabinet” Level 2 (Q 6-8 wks)