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CLINICAL CENTER
ENVIRONMENTAL ASSESSMENT
An environmental assessment:
- answers the questions: "What is happening outside? How
will these trends affect us? What are our internal strengths
and capabilities?"
- requires us to examine the external environment to determine
the outside forces and events that may affect us and examine
our internal environment to assess our ability to manage change
to our advantage. Organizational vision will be shaped by matching
its internal capabilities with the changing demands and opportunities
of the outside world.
External Trends
Societal Issues
- Increasing emphasis on "clinical outcomes" and
"quality of life" related to treatments/interventions
- Increasing focus on "wellness" and "disease
prevention" strategies
- Continued emphasis on technological advances in medicine
and biomedical research
- Information management
- Telemedicine
- Molecular medicine (gene amplification, microchip arrays,
etc.)
- Gene manipulation (cell processing, cellular vaccines, etc.)
- Imaging Sciences
- Difficulty in recruiting clinical research volunteers, especially
from some special populations (e.g., certain minority populations
who have mistrust of the clinical research process)
- Increasing consumerism in healthcare
- Changing demographics (i.e., the 'graying' of the population)
Economic Issues
- Increasing focus on cost as a driver of healthcare delivery
- Continued trend toward outpatient medicine and clinical research
- Continued trend toward 'primary care'
- Academic centers facing increasing competition
- Ongoing struggle between 'managed care' and 'private practice'
Science/Practice/Care-Based Issues
- Basic science progress/scientific discovery fuels progress
in both translational research and clinical care
- Information systems technology is becoming the centerpiece
of excellence in clinical care and clinical research (e.g., paperless
medical records; digital, filmless imaging departments; Clinical
research information systems, Clinical/critical pathways; protocol
mapping)
- Wide variation in clinical practice brings about increasing
need to standardize care and reduce practice variation
Governmental Issues
- Increasing regulation of clinical care and clinical research
- Focus on efficiency, streamlining, and downsizing in the
Federal Government
- The science/politics interface: stem-cell research, fetal
tissue research, cloning, etc.
NIH/Agency Issues
- Increasing emphasis on scientific quality in basic and clinical
research
- Increased rigor in tenuring process
- Prospective review of clinical studies
- External reviews of clinical programs
- Desire for service equity across Institutes
- Need to be able to address emerging scientific opportunities
by changing clinical programs rapidly while still receiving stellar
clinical research support
- Desire for infrastructural improvement
- The new Clinical Research Center
- Information systems
- Clinical Epidemiology and Biostatistics
- Clinical research training
- Standards for clinical research and clinical research support
Internal Capabilities/Strengths
- Critical mass of world-class basic and clinical scientists
at NIH
- Clinical Center staff (scientists and support personnel)
are knowledgeable about clinical research and clinical research
support
- Unique clinical research portfolio (i.e., Phase I and II
clinical trials, natural history and disease pathogenesis studies)
- Proximity and integration of clinical and basic scientists
- Highest quality patient care
- Expanding service orientation
- Funding stability; new funding stream
- Established track-record -- long list of scientific accomplishments
- Data-driven culture
- Dedicated, committed staff
- Clinical research subjects as partners
- Organizational and scientific flexibility -- the CC is able
to respond rapidly to scientific opportunities/changing program
requirements
- Increasing focus on cost-effectiveness and efficiency.
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