Transforming biological discoveries into medical treatment calls for a cadre of health professionals skilled in patient-oriented research. Yet many factors discourage talented persons from choosing clinical research as a profession.
This new volume lays out the problem in detail, with specific recommendations to the federal government, the biotechnology and pharmaceutical industries, professional organizations, the health care industry, organized medicine, and the nation's universities and academic health centers.
The volume explores
- How clinical research is conducted, what human resources are available, and what research opportunities lie ahead.
- Why health professionals become discouraged about clinical research.
- How the educational system has failed in this area and what programs stand out as models.
- How funding affects the supply of researchers.
This practical book will be of immediate interest to public and private agencies funding research, research administrators, medical educators, health professionals, and those pursuing a career in clinical investigation.
- CAREERS in CLINICAL RESEARCH
- Copyright
- Preface
- Contents
- Executive Summary
- FOCUS OF THIS REPORT
- FINDINGS
- RECOMMENDATIONS
- NIH and Other Federal Agencies Supporting Research
- Data Analysis
- Study Section Oversight
- Newly Independent Investigators
- Centers and Program Projects
- General Clinical Research Centers
- Multiyear Stabilization
- Support of Training Programs
- UNIVERSITIES AND ACADEMIC MEDICAL CENTERS
- Academic Recognition and Rewards
- Faculty Protection
- Infrastructure
- Medical School Curriculum
- Postgraduate Training
- ACCREDITATION AND CERTIFICATION ORGANIZATIONS
- Liaison Committee on Medical Education
- Accreditation Committee for Graduate Medical Education
- American Board of Medical Specialties
- EXECUTIVE BRANCH, CONGRESS, INDUSTRY, FOUNDATIONS, AND PROFESSIONAL SOCIETIES
- Conflicts of Interest
- Preserving Academic Health Centers
- 1 Introduction
- SCOPE OF CLINICAL RESEARCH
- ORIGINS OF THE STUDY
- CHARGE TO THE COMMITTEE
- DEFINING CLINICAL RESEARCH
- LIMITS ON THE SCOPE OF THE STUDY
- CONDUCT OF THE STUDY
- Subcommittees
- Task Forces
- Workshop
- Commissioned Papers
- Grants Analysis
- STRUCTURE OF THE REPORT
- 2 Nurturing Clinical Researchers
- ENVIRONMENT FOR CLINICAL RESEARCH
- CLINICAL RESEARCH WORKFORCE
- RESEARCH INVOLVEMENT OF FACULTY
- ACADEMIC RECOGNITION
- FACULTY TRACKS
- COMPETING TIME DEMANDS
- CLINICAL RESEARCH TRAINING
- MENTORING
- LIFESTYLE ISSUES
- CONCLUSIONS
- 3 Clinical Research Funding and Infrastructure
- THE BIG PICTURE
- FEDERAL SUPPORT FOR HEALTH SCIENCES R&D
- National Institutes of Health
- Intramural Research
- Extramural Programs at NIH
- Setting Program Priorities Through Peer Review
- Funding Clinical Research
- IMPAC Data
- OMAR Data
- Ahrens' Analysis
- CRISP Data
- Committee's Analysis
- R&D Centers
- Centers for Disease Control and Prevention
- Agency for Health Care Policy and Research
- U.S. Department of Veterans Affairs
- U.S. Department of Education
- U.S. Department of Defense
- NONPROFIT ORGANIZATIONS
- Foundations
- Voluntary Health Agencies
- Medical Research Organizations
- INDUSTRY
- CLINICAL RESEARCH AND THIRD-PARTY PAYERS
- Third-Party Payers' Perspective
- Involvement in Study Design and Data Analyses
- Data Sharing and Analysis
- Possible Solutions
- MODELS OF COOPERATION
- CONCLUSIONS
- 4 Training Pathways
- DEMOGRAPHICS
- KINDERGARTEN TO COLLEGE
- Classroom Experience
- Science Fairs and Competitions
- Specific Initiatives
- Effecting Change
- Federal Programs
- Nonfederal Programs
- Summary
- RESEARCH EXPERIENCES FOR UNDERGRADUATE STUDENTS
- Institutional Programs
- Federal Programs
- Program Shortcomings
- Assessing Program Effectiveness
- Designing Effective Programs
- Establishing Specific Goals
- Selecting Appropriate Strategies
- Designing an Evaluation Plan
- Characteristics of Successful Programs
- Conclusions
- HEALTH PROFESSIONAL SCHOOLS
- Physician-Scientists
- What's Wrong with Medical Education?
- UNDERGRADUATE MEDICAL EDUCATION
- Medical School Science Curriculum and Culture
- Research Interests of Medical Students
- Research Participation by Medical Students
- Training Programs for Medical Students
- Dual-Degree Programs
- Training in Research Ethics
- Financing and Debt
- GRADUATE MEDICAL EDUCATION
- How Long Should Training Be and What Should the Training Involve?
- External Factors Affecting Research Training During GME
- Residency Review Committees and Certification Boards
- Role of RRCs
- Role of Certification Boards
- Liaison Committee for Medical Education
- BARRIERS TO CLINICAL RESEARCH TRAINING
- Inadequate Training in Research Methods
- Inadequate Mentoring
- Timing of Training
- AVENUES FOR POSTDOCTORAL RESEARCH TRAINING
- ASSESSING THE OUTCOMES OF TRAINING PROGRAMS
- Postdoctoral Ph.D. Training
- Postdoctoral M.D. Training
- Research Career Development Awards
- Clinical Associate Physician Program
- Non-NIH Federal Support
- Private Support
- Payback of Debt
- MODEL PROGRAMS FOR RESEARCH TRAINING
- Overview of Selected Programs
- Robert Wood Johnson Clinical Scholars Program
- University of Michigan School of Public Health
- Harvard Clinical Effectiveness Program
- Other Programs
- Common Characteristics
- Remaining Obstacles
- CONCLUSIONS
- 5 Academic-Industry Relationships
- OBJECTIVES OF ACADEMIC-INDUSTRY RELATIONSHIPS
- TWO CULTURES
- TYPES OF ACADEMIC-INDUSTRY LINKAGES
- PROGRAMS TO HELP COMMERCIALIZE FACULTY RESEARCH
- PREVALENCE OF ACADEMIC-INDUSTRY RELATIONSHIPS
- BENEFITS FOR INDUSTRY
- Access to Fundamental Scientific Advances
- Access to Academic Personnel
- Human Resources Needs
- BENEFITS FOR ACADEMIC INSTITUTIONS, FACULTY, AND STUDENTS
- RISKS, CONCERNS, AND CONFLICTS
- Scientific Communication and Proprietary Rights
- Ownership of Proprietary Rights for New Discoveries
- Exclusivity of Information
- Conflicts of Interest
- Conflict of Commitment
- MANAGING ACADEMIC-INDUSTRY RELATIONSHIPS
- SUMMARY AND CONCLUSIONS
- References
- Appendix A Report of the Task Force on Clinical Research in Dentistry
- EXECUTIVE SUMMARY
- CLINICAL RESEARCH IN DENTISTRY
- Background
- Recommendations
- HUMAN RESOURCES
- BARRIERS TO THE DVELOPMENT AND SUPPORT OF CLINICAL INVESTIGATORS IN DENTISTRY
- Background
- Recommendations
- Measurement of Outcomes
- Projecting the Potential Need for Clinical Researchers
- TASK FORCE MEMBERS
- Appendix B Report of the Task Force on Clinical Research in Nursing and Clinical Psychology
- CLINICAL RESEARCH IN NURSING
- Research Opportunities
- Human Resources
- Clinical Research Training
- References
- CLINICAL RESEARCH IN PSYCHOLOGY
- Research Opportunities
- Well-Established Areas of Investigation
- Promising Newer Areas of Investigation
- Human Resources
- Training
- Barriers
- Failure to Retain Clinical Psychologists as Researchers
- Chilly Academic Climate for Women
- Chilly Academic Climate for Minorities
- Erosion of the Science Training Base by Professional Schools of Psychology
- Increasingly Inflexible Licensing Requirements That Impede Clinical Researchers' Eligibility for Licensure
- REFRENCES
- TASK FORCE MEMBERS
- Appendix C Report of the Task Force on Clinical Research in Surgery
- EXECUTIVE SUMMARY
- DEFINING CLINICAL RESEARCH IN SURGERY
- Examples of Human Studies
- Examples of Animal Studies
- Studies at the Tissue, Cellular, and Molecular Level
- IMPROVING CLINICAL RESEARCH IN SURGERY
- RESOURCE BASE FOR CLINICAL RESEARCH IN SURGERY
- NIH
- BARRIERS TO CLINICAL RESEARCH CAREERS IN SURGERY
- Barriers
- Barriers at Entry Level
- Barriers During Residency
- Barriers After Residency
- General Barriers to Surgical Research
- Special Problems of Women in Surgery
- Minorities in Surgical Research Faculty Careers
- HUMAN RESOURCES PROFILE AND TRAINING BACKGROUNDS OF THE PRESENT COHORT OF CLINICAL RESEARCHERS
- EDUCATION AND TRAINING REQUIREMENTS FOR CLINICAL RESEARCH IN SURGERY
- IMPLEMENTING CHANGES IN CLINICAL RESEARCH TRAINING
- CHANGES IN SURGICAL RESIDENCY TRAINING
- RECOMMENDATIONS
- Collaboration Between Basic Sciences and Department of Surgery
- Proposal to American College of Surgeons Board of Regents to Undertake Direct Support of Research by Surgeons
- NIH—Peer Review
- Collaboration Between Military and Civilian Sectors
- Recruitment and Retention of Academic Faculty in Surgery
- Women in Surgical Research Faculty Careers
- Under-represented Minorities in Academic Surgery
- Development of NIH Surgical Scientist Training Program
- Institution of Changes in Surgical Residency Training
- ORTHOPAEDIC RESEARCH AND EDUCATION FOUNDATION
- TASK FORCE MEMBERS
- Appendix D Agenda for the Workshop on Clinical Research and Training: Spotlight on Funding
- Appendix E Contributors
- Appendix F Biographies of Committee Members
- Glossary
- Index