1. The Next Generation of Outcomes Researchers – Directions for Training AHA 2013 November 18, 2013 Tracy Y. Wang, MD, MHS, MSc

2. All Rights Reserved, Duke Medicine 2007 Disclosures Research grants to the Duke Clinical Research Institute: –Eli Lilly –Daiichi Sankyo –Gilead Sciences –Glaxo Smith Kline –American College of Cardiology –American Society of Nuclear Cardiology –NIH/NHLBI –AHRQ –FDA Honoraria: –Astra Zeneca –American College of Cardiology Foundation

3. All Rights Reserved, Duke Medicine 2007 “Traditional” vs. “Modern” Career Paths Academia is the ivory tower of research Training → K award → R01 Develop expertise in a single niche Publications are the main metric for advancement Many different pathways to success –university, practice-based research, government, health policy organizations, industry, CROs, other Team science Content vs. methodologic expert

4. All Rights Reserved, Duke Medicine 2007 Science has changed Efficacy: –randomize Group A vs. Group B → count events –meta-analysis Effectiveness: –Dissemination and implementation –Impact on multiple stakeholders individual patients, family, health care providers, healthcare systems, policy makers. –Quality improvement –Safety –Practice and policy innovation

5. All Rights Reserved, Duke Medicine 2007 Projected U.S. National Health Expenditures by Source GDP = gross domestic product. Source: Estimates by Actuarial Research Corporation for The Commonwealth Fund. $ billion % GDP: 17.9% 18.7% 20.5%

6. All Rights Reserved, Duke Medicine 2007 What hasn’t changed…. The field is still looking to develop investigators who have: Passion for the work Ability to ask good questions Lifelong dedication to learning Resilience to failure

7. All Rights Reserved, Duke Medicine 2007 What hasn’t changed…. The field still needs mentors / training programs: Motivated to develop early careers Institutional commitment and supportive environment Opportunities for hands-on apprenticeship High quality core didactic training Willingness to cultivate independence

8. All Rights Reserved, Duke Medicine 2007 Adapted from www.despair.com FELLOWS

9. All Rights Reserved, Duke Medicine 2007 Core Elements of Training Principles of clinical research (objectives, hypotheses, population, outcomes) Biostatistics (descriptive, estimation, hypothesis testing) Study design (protocol, sample size, randomization, end points) Ethical foundation (consent, conflict of interest, regulatory) Fundamental skills (writing, presentation, grants, IRB applications, peer review) “No clever analysis can rescue a bad or flawed design” - David DeMets, PhD

10. All Rights Reserved, Duke Medicine 2007 Contemporary CER Competencies The road(s) now well-traveled Clinical epidemiology –RCTs –Practical clinical trials –Non-trial clinical research –Systematic reviews/meta analyses –Pharmacoepidemiology –Methods research Biomedical informatics –Electronic health records –Re-use of clinical data –Information needs assessment –Ontology development/ knowledge management –Computer sciences –Social Media Clinical practice guidelines Implementation and dissemination Health psychology Sociology Health economics/Cost effectiveness Decision analysis/cognitive science Practice-based network research Community engaged research Patient and stakeholder engagement Library sciences Advocacy/Legislation Health policy Health system engineering 10 Adapted from CTSA Consortium Strategies Coal Committee on CER: Workgroup on Workforce Development. 2010

11. All Rights Reserved, Duke Medicine 2007 Priorities for Training One size no longer fits all - prepare trainees for diverse career options Multidisciplinary repertoire of technical knowledge and skills Expertise in research team building, leadership, and negotiation Exposure to current and future collaborators Practical training in research management

12. All Rights Reserved, Duke Medicine 2007 “We are making a mistake offering traditional advice and training on grantsmanship in the current funding environment.” - Prominent cardiovascular outcome researcher

13. All Rights Reserved, Duke Medicine 2007

14. Disruptive Innovation Clayton Christenson, Disruptive innovation

15. All Rights Reserved, Duke Medicine 2007 Additional thoughts on training Ability to communicate with non-researchers Cultivate optimism Even powerhouses don’t have everything “Exchange programs” Multi-mentor model Flexibility in training time We need research on training