Issues in Team and
Translational Science
Leighton Chan MD, MPH
Chief, Rehabilitation Medicine
Department
National Institutes of Health
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
“
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
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
Eight Phase Model
•
•
•
•
•
•
•
•
Basic research
Hypothesis development
Pilot-applied research
Prototype evaluation studies
Efficacy trials
Treatment effectiveness trials
Implementation effectiveness trials
Demonstration evaluations
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)
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
Translational Models
Five-Phase Model
1.Basic research
Eight-Phase Model
1. Basic research
2. Hypothesis development
2. Methods development 3. Pilot-Applied research
4. Prototype evaluation studies
3. Efficacy trials
5. Efficacy trials
5. Effectiveness trials
6. Treatment effectiveness trials
7. Implementation effectiveness
trials
5. Dissemination
National Institute
of Health Type 1
and Type 2
8. Demonstration evaluations
Type 1
Type 2
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
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
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
NIH
•
•
•
•
27 Institutes
Intramural vs Extramural research
Annual Budget: $30 billion
NCMRR- $77-90 million
A piece of the pie
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
1 http://nihroadmap.nih.gov
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
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
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
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.
NIH Clinical Research Center
242 inpatient beds, 90 day hospital beds
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
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
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)
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
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
Clinical Research Continuum
Translational Blocks
Lack of Willing Participants
Career Disincentives
Regulatory Burden
Practice Limitations
Fragmented Infrastructure High Research Costs
Incompatible Databases
Lack of Funding
Lack of Qualified Investigators
1
Basic Biomedical
Research
Translation from
Basic Science to
Human Studies
2
Clinical Science
and Knowledge
Translation of New
Knowledge Into Clinical
Practice and Health
Decision Making
Sung, NS, et al, JAMA March 12, 2003 Vol 289, No. 10
Improved
Health
Rehabilitation Medicine
Department
1. Provides clinical support to institute
intramural investigators
– Meet patient rehab needs
– Perform functional assessments
2. Initiate rehabilitation research though the
Physical Disabilities Branch (NICHD)
3. Educate clinical research fellows
Rehabilitation Medicine
Department
•
•
•
•
•
•
•
Physiatrists
Physical Therapists
Occupational Therapy
Recreation Therapy
Speech and Language
Vocational Rehabilitation
Physical Disabilities Branch
6
13
8
22
2
1
39
91
Physical Therapy
• Special expertise:
– Pediatric
– Orthopedic
– Orthotics
– Neurologic
– Cancer/Lymphedema
Physical Therapy
NIH PHYSICAL THERAPY SECTION RESEARCH PRODUCTIVITY 1994 - 2005
30
28
28
25
22
21
20
18
17
16
14
15
12
11
9
9
10
12
9
8
7
5
5
11
2
3
2
11 11
11
5
12
8
8
6
5
3
3
6
3
1
0
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
Number of Peer-Reviewed Abstracts and Peer-Reviewed Papers Published
0.5 FTE staff increase 1994-2005
Papers
Abstracts
TOTAL
2005
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
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
Speech and Language Pathology
• Research
– serve on 12 protocols as associate
investigators assessing and treating
• speech
• swallowing
• Language/cognitive disorders
• Hire more staff
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
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
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
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.
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
Descargar

Document