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Harvard Postgraduate Educational Program in Clinical/Translational Science. Presentation to ETEC May 6, 2009. The problem…. Resources available at Harvard. Labs Courses Degree Programs. PhD Scientist.
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Harvard Postgraduate Educational Program in Clinical/Translational Science Presentation to ETEC May 6, 2009
The problem…. Resources available at Harvard LabsCourses Degree Programs PhDScientist Variation in :InterestsExperienceSkill SetsAwareness of Available ResourcesMentoring Relationships Fuzzy, near random interface with current training opportunities MD Collaborative C/T Res Personnel (e.g. RN, CRA, Data Mgr, Biostatistician etc) Eager fellows and Jr Faculty interested in Clinical/Translational Research at Harvard Institutions
www.ctsaweb.org * 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
Clinical/Translational Training Funded by Catalyst (Current) Basic Biomedical Science at HMS Overview of Current/Planned Masters Programs in C/T Science Currently funded by Catalyst Scholars in Medicine--HMS w Scholarly Project HMS Prime
Clinical/Translational Research Education Oversight (Current) Compendium of Current Courses Assembled White Paper Drafted on Issues
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
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 Core Competencies in Clinical/Translational Research CTSA RFA RM-09-004 Catalyst ETEC Group White Paper Feb 2009 Additions: Genetics, Management of Research Resources
Sung JAMA 289: 1278,2003 Westfall JAMA 297: 403,2007
PhDScientists Collab C/T Res Personnel MD Change Clinical Practice(T2) PracticeBased Research(T3) Proof of Concept(T1) Basic Biomedical Research That Has Arrived at Threshold for Human Investigation Track Careers of C/T Investigators Harvard Postgraduate Educational Program in Clinical/Translational Science
Overview of Vision for Clinical/Translational Res. Ed under Catalyst:Creation of a Harvard Postgraduate Education Program in Clinical/Translational Science Communications (Oral, Written) Research Ethics and Regulatory Knowledge/Resources Scope of Material Special Methods: eg. Lab/Genetics/Imaging/Informatics Biostatistics/Epidemiology/Research Design Advanced Range of Learner Needsand Interests PracticeBasedResearch(T3) Change Clinical Practice(T2) Proof of Concept(T1) 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 Translation of Discoveries to Care of Patients Introductory Spectrum of Training Across Clinical Research Continuum
Overview of Vision for Clinical/Translational Res. Ed under Catalyst:Creation of a Harvard Postgraduate Education Program in Clinical/Translational Science Examples of Current High-Quality But Largely Uncoordinated Training Efforts: e.g. Training in Genetics Based Research e.g.AdvancedImaging Communications (Oral, Written) Research Ethics and Regulatory Knowledge Special Methods: eg. Lab/Genetics/Imaging/Informatics Advanced Biostatistics/Epidemiology/Research Design PracticeBasedResearch Change Clinical Practice Proof of Concept Introductory Spectrum of Educational Needs
Overview of Vision for Clinical/Translational Res. Ed under Catalyst:Creation of a Harvard Postgraduate Education Program in Clinical/Translational Science Courses Longitudinal Other Training Experiences Short Nano Programs for K Awardees(KL2 CTSA req) Programs to Support Mentors and Established Investigator(Research Management, Team Leadership) 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) 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 Bioinformatics Genotyping Stem Cells Mab Proteomics etc For example: Advanced Training in Specialty Cores Basic Biomedical PhD Training Certificate Certificate Masters Advanced (To Prepare Investigators for Writing and conducting a Clin Trial) Masters in Med Science(Preparation for Career in Clin Res) Introductory(Trainees/Jr Faculty who want to do clin res) Trainees/Jr Faculty at Harvard Harv College, HMS Undergraduates Wishing to Attend Lectures HMS Prime
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 Consultative Cores:BiostatisticalGeneticsImaging Mentoring + Professional Development ResearchResources Intake and Triage Service Advanced (To Prepare Investigators for Writing and conducting a Clin Trial) Masters in Med Science(Preparation for Career in Clin Res) Introductory(Trainees/Jr Faculty who want to do clin res) Trainees/Jr Faculty at Harvard HMS Prime
Overview of Vision for Clin Res Ed under Catalyst:Creation of a Harvard Postgraduate Educational Program in Clinical/Translational Science Advanced Training in Specialty Cores Introduction to Clin Inv Training
Overview of Vision for Clinical/Translational Res. Ed under Catalyst:Creation of a Harvard Postgraduate Education Program in Clinical/Translational Science Advanced Training in Specialty Cores Advanced Clin Res Training
Overview of Vision for Clinical/Translational Res. Ed under Catalyst:Creation of a Harvard Postgraduate Education Program in Clinical/Translational Science Advanced Training in Specialty Cores K12 (KL2) for Jr Faculty(CTSA req) Masters in Med Science Other K Award Programs HMS Prime
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(Proposal for New Model) Creation of Shared Courses: Ethics, GCP, Reg Knowledge PracticeBasedResearch Change Clinical Practice Proof of Concept CITP Shared Publicity about Programs and Application Process Scholars Clin Effect Global Health Bioinformatics HMS Prime
Programs to Support Mentors and Established Investigator(Research Management, Team Leadership) For example: Mentoring Training
Rough Draft of IT Needs Input Content Intro, Adv, Masters, K12 etc Topics: Biostat, Genetics, etc Harvard Postgraduate Education Program in Clinical/Translational Science Create Algorithm for User Query of Content of Program Sort Content Based on Query Registrar Functions Major Categories of Informatics Needs: Searchable catalog Content Management Registrar/Administrative Functions Archive Content
Harvard Postgraduate Education Program in Clinical/Translational Science Governance “Cabinet” Level 1(q 2-4 wks) • Antman • Ware • Golan • TBN Advisory Board Administration* • TBN • Director--Antman • Administrator** • Asst. Admin • Other “Cabinet” Level 2(Q 6-8 wks) • TBN • *Functions • Registrar • Certification • Scheduling • IT • Faculty Interface • **Knowledge Set • Scientific Experience (preferably in clin res) • Organizational experience • Leadership experience • Cross Cutting experience • Degree: PhD or Masters