Issues in Team and Translational Science

1. Issues in Team and Translational Science Leighton Chan MD, MPH Chief, Rehabilitation Medicine Department National Institutes of Health

2. “ There does not exist a category of science to which one can give the name ‘applied science.’ There are science and the applications of science, bound together as the fruit of the tree which bears it.” Louis Pasteur

3. Translational Medicine • Translation of evidence based research findings into practice • Findings have not been implemented into practice in widespread settings • May take 10 -20 years for original research to translate to routine medical practice

5. Five Phase Model • Basic research • Methods development • Development of outcome measures, pilot studies • Efficacy trials • evaluations of health status or behavior change under scientific conditions • Effectiveness trials • evaluations under real or usual conditions • Dissemination trials • Examine and evaluate conditions that promote or impede widespread use

6. Eight Phase Model • Basic research • Hypothesis development • Pilot-applied research • Prototype evaluation studies • Efficacy trials • Treatment effectiveness trials • Implementation effectiveness trials • Demonstration evaluations

7. Five Phase Model • Phase models assume linear progression from basic research to clinical application • Each of five phases could work in a feedback loop • Ex. Phase 2 could relate to dissemination (phase 5) which could feedback to other methods of development (Phase 2)

8. Personnel Roles • Researcher-practitioner team • Doctorate level researchers • Persons trained for applied work • Research planning, implementation analysis, data management, outcome analysis, reports • Health promotion practitioners • Recruitment, scheduling, maintaining field relationships • Communication necessary to facilitate translation

9. Translational Models

10. Speed of Translation • “Quick” translation to clinical practice • Basic research not easily translated • Need to determine which have potential to translate effectively • Slow, but necessary process to evaluate and include basic research findings

11. 7 common barriers to translation • Basic research not clinically relevant ( generated for its own sake) • Clinical practice guidelines in literature insufficient for translation • Comparisons among programs hampered by competition, conflict of interest • Perception that translation will be lengthy and expensive • Time necessary to train researchers to communicate and share across fields • Practitioners unable to utilize an innovation • Researchers don’t interpret findings so that they can be easily disseminated

12. Conclusions • Translation of research to practice that promotes improvement in health care outcomes continues to be an obstacle to improving quality of health care delivery • Negotiations and collaborations between research and practice is needed • Leapfrog group

13. NIH • 27 Institutes • Intramural vs Extramural research • Annual Budget: $30 billion • NCMRR- $77-90 million

14. A piece of the pie

15. NIH Roadmap1 • Approach to accelerate fundamental discovery and translation of research knowledge into effective prevention strategies and new treatments • Strategic initiatives will address critical roadblocks and knowledge gaps that currently constrain rapid progress in biomedical research. • Synergize the work of many NIH Institutes and Centers 1http://nihroadmap.nih.gov

16. NIH Roadmap • Appx. 36% of budget clinical research • 80% budget for extramural research, 10% budget for Intramural including 1200+ investigators • Clinical Center model facility for translational research and training • Result of changing health care needs and costs require changes in biomedical research • Shift from acute to chronic • Aging of population • Public health challenges

17. NIH Roadmap • Perceived loss of talent in translational medicine and clinical sciences • Difficulty finding scientist collaborators who can translate and clinically apply from basic science • Researchers interested have difficulty finding facilities to apply their interests

18. NIH Roadmap • Develop national system of interconnected clinical research networks • NIH National Electronic Clinical Trials and Research Network (NECTAR) • Possible National Clinical Research Associates Program • Patient Reported Outcomes Measurement Information System (PROMIS) • Facilitate comparison among research studies • Enhance measurement precision

19. Development of the CRC • The CRC reflects the parallel priorities of patient care and clinical research • Proximity of research labs and patient-care units facilitates interactions between scientists, clinicians, and patient volunteers • Permits clinician-scientists to work both in the lab and with patients • Helps clinicians and basic scientists learn from each other in gathering places, and encourages the development of young scientists interested in clinical research.

20. NIH Clinical Research Center 242 inpatient beds, 90 day hospital beds

21. Evidence to Practice Gap • Medical journals must facilitate access and understanding of new knowledge for it to be implemented • Health researchers must communicate to researchers and practitioners • Health profession teachers should emphasize transitional processes

22. Clinical Research • Includes: • Clinical trials • Outcomes • Health delivery • Epidemiological and psychosocial research • Translational clinical research requires: • Physician-investigator skilled in biomedical science • Recognition of appropriate patients to investigate

23. Clinical Research • 2 types of translational clinical investigators • Disease-oriented researcher primarily working in labs or with animals, not patients • Patient-oriented translational clinical investigators (POTCI)

24. Clinical Research • NIH and Academic Health Centers (AHC) need to support POTCI’s • National bird of academic medicine may be the crane • AHC’s must foster collaboration in clinical research • Focus on publications needs to be expanded to include all authors contributions

25. Clinical Research • “C’s” of clinical research: • Clinical focus - interest in a disease and pt’s with it • Collaboration with basic scientists and full time physicians • Courage to learn new techniques and approaches • Cooperative spouses • Conflict of interest • Caring mentors

26. Clinical Research Continuum Sung, NS, et al, JAMA March 12, 2003 Vol 289, No. 10

27. Rehabilitation Medicine Department • Provides clinical support to institute intramural investigators • Meet patient rehab needs • Perform functional assessments • Initiate rehabilitation research though the Physical Disabilities Branch (NICHD) • Educate clinical research fellows

28. Rehabilitation Medicine Department • Physiatrists 6 • Physical Therapists 13 • Occupational Therapy 8 • Recreation Therapy 22 • Speech and Language 2 • Vocational Rehabilitation 1 • Physical Disabilities Branch 39 91

29. Physical Therapy • Special expertise: • Pediatric • Orthopedic • Orthotics • Neurologic • Cancer/Lymphedema

30. Physical Therapy

31. Physical Therapy • Search for a new Section Chief • Fine tune this section • Enhance our skills in cardiopulmonary rehabilitation • Create new research fellowship with APTA • Encourage collaboration with the PDB

32. Occupational Therapy • Research • Assessing functional ability as an outcome measure of drug trials • Examining daily function and self-regulation in individuals with obesity • Determining motor patterns and response to motor training for people with hand dystonias

33. Speech and Language Pathology • Research • serve on 12 protocols as associate investigators assessing and treating • speech • swallowing • Language/cognitive disorders • Hire more staff

34. Recreation Therapy • Staff consists of 18 Certified Recreational Specialists including: • ACSM Certified fitness instructors • Biofeedback • Relaxation • 4 Contracted staff • Music therapist • Art therapist • Massage therapist • Acupuncture, acupressure, Tai Chi • 30 Volunteers 50 hours a week

35. Recreation Therapy • Search for a new Section Chief • Largest RT Department in the country • Great opportunity • Ability to take the section to the next level of growth- • From general recreation to research on specific therapeutic activities

36. Physical Disabilities Branch • Mission to develop and disseminate: • innovative rehabilitation technologies • provide training and resources to investigators • A multi-disciplinary team is organized into two sections: • biomechanics • biomedical engineering • Focused on imaging technology • Novel ways to measure human movement

37. Physical Disabilities Branch • Recent BCS review that will be helpful in guiding strategic planning • Next phase of growth will be • Translate the new technologies into clinical research • Add additional areas of focus: health services research, cardiopulmonary rehabilitation, psychological instrument development, etc.

38. Department of Rehabilitation Medicine • The ultimate goal of the department is to improve the lives of people with disabilities and reduce the cost of health care