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.