Workforce Development Domain Task Force The WF DTF Lead Team Rebecca Jackson (Ohio State) Richard Barohn (Kansas) Carrie Byington (Utah) Lee Nadler (Harvard) Christine Sorkness (Wisconsin) Joan Nagel (NCATS) Lynda Lane (C4)

Workforce Development Domain Task Force IOM Report - NCATS ACWG The translational science workforce has the skills and knowledge necessary to advance translation of discoveries. This goal focuses on: Building an environment that supports and values translational science as “the place to go” for those who want to pursue high-impact careers in health sciences. Training, educating and providing all members of the research team with the skills sets and tools needed to advance the field of translational science Developing a translational science workforce that can meet the needs of today and tomorrow.

Specific Goals for WF Development Incubator for novel training models, core competencies and fundamental skill sets Be more inclusive, provide more flexible learning modules for all members of the workforce e.g. GCP training platform Embrace Innovative Curricula and Team-Based Education and Training entrepreneurship, regulatory science, community engagement Recruit and support diverse research team members who are underrepresented in translational science research Provide a plan to facilitate the dissemination of educational resources to promote flexible learning tools and schedules for all members of the workforce

Highlights of WF Development Working Groups-Supplements 1. Clinical Research Training for Investigators 2. GCP Module Development for Social-Behavioral Research Teams 3. Harmonizing Competencies to Facilitate Personalized Pathways 4. Towards a Sustainable Career in TS 5. New Opportunities

Clinical Research Training for Investigators NCATS Goal: provide more flexible learning modules for all members of the workforce e.g. GCP training platform WG Leads: Jonelle Wright and Richard Barohn

Clinical Research Training for Investigators - Overview Purpose: Create on-line practical trainings to build investigators’ operational knowledge and logistical skills in protocol development and implementation Background: In addition to learning the scientific method, clinical investigators need to know the “how-tos” of safe and competent research There is widespread demand for investigator training on the operational aspects of clinical and translational studies

Clinical Research Training for Investigators – Approach Focus Basic operational aspects of clinical studies Stages of the study lifecycle Workgroup 13 members representing 10 institutions, FDA, and professional organizations Cincinnati Miami Penn State Hershey Stanford Tufts FDA ACRP

Clinical Research Training for Investigators – Action Plan Game Plan Review ECRPTQ Competency Domains/Statements Decide fundamental core curriculum Decide course/module content NIH Collaboratory

Workgroup Leads: Nancy Calvin-Naylor and Christy Byks-Jazayeri GCP Module Development for Social/Behavioral Research Teams NCATS Goal: provide more flexible learning modules for all members of the workforce e.g. GCP training platform Workgroup Leads: Nancy Calvin-Naylor and Christy Byks-Jazayeri

Background Enhancing Clinical Research Professionals’ Training & Qualifications (ECRPTQ) – Phase 1, GCP Requested a no-cost extension to develop online training Launched design work in Summer 2015 with Innovative Learning Group (ILG) Issued an RFP for module development in Fall 2015 Vendor selected and work began in January 2015

Vendor Information Torrance Learning www.torrancelearning.com Chelsea, MI Torrance team: Megan Torrance, CEO Jen Vetter, Project Manager Contracted for 9 modules not to exceed 2-3 hours total Video, photographs, audio, and animation including pre-production (scripting, storyboarding) and post-production (editing) using Articulate Storyline Deliverable = 9 files ready to upload to a SCORM1.2-compliant learning management system

Content Development Susan Murphy (U-M) led a team with expertise in social/behavioral research who organized content around GCP principles The team mapped the GCP principles to the ECRPTQ competencies Iterative process with Torrance to produce scripts/storyboarding based on input from subject matter experts

Module Outline Module 1: Introduction, Roles & Responsibilities Module 2: Research Protocol Module 3: Informed Consent Process Module 4: Confidentiality/Privacy Module 5: Recruitment/Retention Module 6: Participant Safety/Adverse Event Detection & Reporting Module 7: Quality Control/Assurance Module 8: Research Misconduct Module 9: Conclusion/Summary

Approach Interactive – learners do not just read blocks of text Engaging – material is dynamic Relevant – content developed by SMEs Based on learning theory Focused on helping learners acquire competence through skills tests embedded in modules

Access NCATS will host the modules on its servers CTSA hubs can download the modules Institution-specific material can be appended to the modules as needed Modules can then be uploaded on institutional servers and metrics tracked as appropriate (e.g., number of views, scores on assessments, etc.) Demo http://torrancelearning.com/clients/michr/goldilocksdemo/

Social/Behavioral GCP Working Group Faculty Lead: Susan Murphy, MICHR, University of Michigan Administrative Lead: Christy Byks-Jazayeri, MICHR, University of Michigan Alecia Fair, Vanderbilt University Alison Miller, University of Michigan Angie Lyden, University of Michigan Blair Holbein, UT Southwestern Catherine Radovich, University of Michigan Edward Ellerbeck, University of Kansas James Giordano, Georgetown University James Spilsbury, Case Western University Jen Miner, University of Michigan Jenna Rouse, ACRP Kelly Unsworth, University of Rochester Laura Denton, University of Michigan Laura Fluharty, University of Pennsylvania Laurie Lester, Dartmouth College Lise Anderson, University of Michigan Mary-Tara Roth, Boston University Nancy Calvin-Naylor, University of Michigan Nicole Exe, University of Michigan Penny Jester, University of Alabama Rebecca Brouwer, Duke University Susan Rose, University of Southern California Teri Hinkley, ACRP Valerie Kahn, University of Michigan Vic Divecha, University of Michigan Additional thanks to all SMEs, Alpha reviewers and Beta testers from across the CTSA consortium.

Polling question Social and Behavioral Research Training Modules Once available would you offer Social and Behavioral GCP Research Training as an alternative to meet traditional GCP training requirements for social and behavioral scientists? Yes No Don’t Know

WG Leads: Beth Knutson and Rebecca Jackson Harmonizing Competencies to Develop Personalized Education and Career Development Pathways NCATS GOAL: incubator for core competencies and fundamental skill sets WG Leads: Beth Knutson and Rebecca Jackson

Harmonizing Competencies Problem – Relevance and usefulness of the Clinical and Translational Research Core competencies to CTSA hubs could be better defined. Fundamental skills sets and a clear pathway needed by the Translational Science workforce is not clear (IOM report) Defining Target audiences for translational research core competencies https://ctsacentral.org/consortium/best- practices/335-2/ Other competencies that emanate from CTSA efforts – Regulatory Science, Informatics, how to harmonize and reduce redundancy Key Deliverable: Refining core competencies to reduce overlap and increase usefulness to CTSA consortia with reorganization BY topics and target audiences

CTSA Working Group Competencies CEnR-Competencies with Learning Objective CER Competencies Informatics Competencies CTSA Special Interest Competencies CTSA Core Competencies for Masters Degree Regulatory Science Competencies nihms228803 other cer Combined have identified over 70 competencies

What are the Workforce Roles? The following are referenced in CTSA competency publications K Scholar T Scholar MS Research Scholar PI Research Coordinator Community Engagement Pediatric Researcher T1 Researcher Academia Industry Drug Development Biostatisticians Informaticians Collaborating Physician Medical Device and Tech Transfer Clinical Trial Researcher

CTSA Working Group Competencies CEnR-Competencies with Learning Objective CER Competencies CTSA Core Competencies for Masters Degree CTSA Special Interest Competencies Informatics Competencies nihms228803 other cer Regulatory Science Competencies K Scholar T Scholar MS Research Scholar PI Research Coordinator Community Engagement Pediatric Researcher T1 Researcher Academia Industry Drug Development Biostatisticians Informaticians Collaborating Physician Medical Device and Tech Transfer Clinical Trial Researcher This question led to a new proposed framework for harmonizing and mapping competencies and educational pathways…..

Harmonizing Competency Framework Operationalize Definition of CTS Roles Overlay identified competencies, reducing redundancies Personalized Educational Pathway

Operationalize Definition of CTS Roles Overlay identified competencies reducing redundancy Personalized Educational Pathway Defining Roles One individual could theoretically need competencies across multiple published competencies. For example: An MD trainee in an MS degree program with an interest in pediatric medical device research What competencies might this individual draw from? CTSA Core Competencies for Master’s Candidates CTSA Special Interest Competencies (Pediatrics) CTSA Special Interest Competencies (Medical Devices) What educational pathways might this individual seek? K or T Scholar Programs (institution specific)

Approach: Personalized Career Trajectory Decision Tree For sake of space, this is illustrated as a unidimensional hierarchy

Polling question Education and Training of Translational Scientists Are you utilizing the clinical and translational science research competencies that are on the C4 website? Yes No What website?

Polling question Education and Training of Translational Scientists Do you believe competencies are of added value to translational science researchers? Yes No

Polling question Education and Training of Translational Scientists Are you currently mapping the competencies into your training programs? Yes No

Working group Leads: Carrie Byington and Christine Sorkness Towards a Sustainable Career in Translational Science NCATS Goal: incubator for novel training models Working group Leads: Carrie Byington and Christine Sorkness

Background Success of a sustainable and diversified biomedical workforce is dependent on programs that cultivate talented translational researchers, mentoring them to independent long term careers Need to identify best “K to R” practices from CTSA KL2 programs, and key program elements that contribute to success Need to disseminate “best practices” across the CTSA consortium

Robinson GFWB et al. Academic Medicine 2016 Apr; 91(4):570-82. Understanding Career Success & Contributing Factors Personal Factors Networking Persistence & resilience Initiative Autonomy Personal & professional balance Organizational Factors Mentor(s) & mentorship Protected Time Institutional resources & support Robinson GFWB et al. Academic Medicine 2016 Apr; 91(4):570-82.

Action Plan KL2 program survey of current “best practices” in the contemporary CTSA era Ascertainment of impact of these practices on career success, broadly defined as “continued employment in translational science” Inclusion of both traditional and non-traditional metrics to reflect roles in team science Survey to be informed by expertise and publications of CTSA KFC leaders CTSA Common Metrics to be included

4/13/16 WDDTF Roundtable Discussion: Career Sustainability Definition of “career sustainability,” inclusive of multiple pathways Capture of CTSA program support of other academic K and individual K scholars Extent of formal mentor training in KL2 program and processes aimed to diversify the workforce Time frame for the survey responses (2006-2013) ID of WG, Chair/Co-Chair, timeframe for construct, administration, and dissemination of survey; ID of support needed Suggestions on the draft survey framework

Polling question Towards a Sustainable Career in CTS All CTSA KL2 programs should offer formal K to R grant writing sessions. Yes No Don’t know

Polling question Towards a Sustainable Career in CTS All CTSA KL2 programs should mandate formal mentor training? Yes for both the KL2 mentor and the KL2 scholar Yes for the KL2 mentor (with an option for the KL2 scholar) No

Polling question Towards a Sustainable Career in CTS The number of KL2 positions allowed in the CTSA program? Not Enough Enough Too many

New WF Development Collaborative Opportunities New WF Development Collaborative Opportunities Research Process Improvement for Physician-Scientist MOC Collaboration with FDA on Federated Educational Platform The WF DTF as a Resource for Education and Training Initiatives

Research Process Improvement for Physician-Scientist MOC Maintenance of Certification (MOC) is required by 21/24 ABMS Boards An option for part IV MOC is to credit QI activity sponsored by institutions Aligns professional development with organizational quality & safety improvement goals to improve efficiency and reduce physician burden Surveys suggest that these QI activities do not reflect the needs of physician scientists

Proposal: Research QI for MOC Purpose: Assess feasibility and pilot the application of Research QI project to meet part IV requirement Define Research QI Portfolio Program standards and guidelines requirements for meaningful participation Pilot program at 2-4 CTSA programs to determine burden (to institutions and individuals) Why should CTSA Consortium Collaborate with ABMS? Aligned with NCATS and CTSA Consortium goals to increase TS research efficiency Career Development/Sustainability Benefits Reduce burden to physician scientists Align MOC activities with career development goals

Polling question Research QI for MOC Should the CTSA Consortium (or WF DTF) collaborate with ABMS on Research QI Pilot as an option for MOC for physician-scientists? Yes No Not sure

Update on a Federated Education Network Informatics Development of Federated Network Federated network quick to deploy, low (shared) costs, flexibility, ability to customize, local control over data Ontology-based organization of resources allows for more granular identification of resources of interest Embedded metrics and assessments Innovation grant submitted and under review for proof-of-concept development and testing Current Activities Supporting Federated Network Elucidation of personal pathways in DTF To be leveraged for development of initial decision support tools Increase collaboration with other stakeholders More detailed engagement of FDA and Pharma in development

The WF DTF as a Resource for Education and Training Initiatives “Coming together is a beginning. Keeping together is progress. Working together is success.” Henry Ford

Discussion Are we addressing the most critical gaps and issues that will positively impact a sustainable clinical and translational science workforce?