Central Challenges Facing the National Clinical Research Enterprise

JAMA

Volumn 289, Issue 10, 2003, Pages 1278-1287

  Sung, Nancy S ^a   Crowley, William F ^b   Genel, Myron ^d   Salber, Patricia ^e   Sandy, Lewis ^f   Sherwood, Louis M ^g   Johnson, Stephen B ^h   Catanese, Veronica ^j   Tilson, Hugh ^l   Getz, Kenneth ^c   Larson, Elaine L ⁱ   Scheinberg, David ^k   Reece, E Albert ^m   Slavkin, Harold ⁿ   Dobs, Adrian ^p   Grebb, Jack ^q   Martinez, Rick A ^r   Korn, Allan ^s   Rimoin, David ^o  

^a Burroughs Wellcome Co   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c CenterWatch   (United States)

^d YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e CA Pub Employees Retirement Syst   (United States)

^f ROBERT WOOD JOHNSON FOUNDATION   (United States)

^g UNIVERSITY OF PENNSYLVANIA   (United States)

^h Department of Medical Informatics ^*  (United States)

ⁱ NewYork Presbyterian Hospital   (United States)

^j Och Spine at New York Presbyterian Hospitals   (United States)

^k MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^l IL   (United States)

^m UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

ⁿ UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^o CEDARS SINAI MEDICAL CENTER   (United States)

^p JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^q JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^r JOHNSON AND JOHNSON   (United States)

^s Blue Cross and Blue Shield Association   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; DATA BASE; DECISION MAKING; FINANCIAL MANAGEMENT; HEALTH CARE COST; HEALTH CARE POLICY; HEALTH CARE SYSTEM; INFORMATION SYSTEM; MEDICAL PRACTICE; PRIORITY JOURNAL; PUBLIC HEALTH; PUBLIC OPINION; REVIEW; TRAINING; UNITED STATES; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CLINICAL TRIAL; CONFIDENTIALITY; CONFLICT OF INTEREST; CONSENSUS; COOPERATION; ECONOMICS; EDUCATION; ETHICS; EVIDENCE BASED MEDICINE; GOVERNMENT; HEALTH CARE PLANNING; HUMAN; INFORMED CONSENT; INVESTMENT; LEGAL ASPECT; MANAGEMENT; MEDICAL PROFESSION; MEDICAL RESEARCH; ORGANIZATION; ORGANIZATION AND MANAGEMENT; PATIENT SELECTION; PERSONNEL; STANDARD;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

BIOMEDICAL RESEARCH; CLINICAL TRIALS; CONFIDENTIALITY; CONFLICT OF INTEREST; CONSENSUS; COOPERATIVE BEHAVIOR; EVIDENCE-BASED MEDICINE; HEALTH OCCUPATIONS; HEALTH POLICY; HEALTH PRIORITIES; HUMANS; INFORMATION SYSTEMS; INFORMED CONSENT; INSTITUTE OF MEDICINE (U.S.); INVESTMENTS; PATIENT SELECTION; POLICY MAKING; PRIVATE SECTOR; RESEARCH PERSONNEL; RESEARCH SUPPORT; UNITED STATES; UNITED STATES GOVERNMENT AGENCIES;

EID: 0037433442     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.289.10.1278     Document Type: Review

References (123)

1. Heninig S, Quon AS, Meyer R, Korn D. The Changing Landscape for Clinical Research. Washington, DC: Association of American Medical Colleges; 1999.
2. Clinical Research: A National Call to Action. Washington, DC: Association of American Medical Colleges, American Medical Association, and Wake Forest University School of Medicine; 1999.
3. For the Health of the Public: Ensuring the Future of Clinical Research. Washington, DC: Association of American Medical Colleges; 1999.
4. Ochs N. Final NIH doubling installment of $3.7 billion voted in Senate L/HHS subcommittee bill. Washington Fax. July 18, 2002.
5. Clinical Research Roundtable home page. Available at: http://www.iom.edu/crr. Accessed February 6, 2003.
6. Institute of Medicine Clinical Research Roundtable. The Clinical Investigator Workforce: Clinical Research Roundtable Symposium I. Washington, DC: National Academy Press; 2001.
7. Institute of Medicine Clinical Research Roundtable. Public Confidence and Involvement in Clinical Research: Clinical Research Roundtable Symposium II. Washington, DC: National Academy Press; 2001.
8. Institute of Medicine Clinical Research Roundtable. Exploring the Map of Clinical Research for the Coming Decade: Clinical Research Roundtable Symposium III. Washington, DC: National Academy Press; 2001.
9. Salber PR. The role of purchasers in the clinical research enterprise. J Investig Med. 2002;50:170-172.
10. Marwick C. Networks aim to bridge gap between clinical research, medical practice. J Natl Cancer Inst. 2002;94:478-479.
11. Tunis S, Korn A, Ommaya A, eds. The Role of Purchasers and Payers in the Clinical Research Enterprise: Workshop Summary. Washington, DC: National Academy Press; 2002.
12. Cabana MD, Rand CS, Powe NR, et al. Why don't physicians follow clinical practice guidelines? JAMA. 1999;282:1458-1465.
13. Wennberg J. Why evidence-based medicine has been a failure. Presented at: National Academy of Sciences Clinical Research Roundtable Symposium: "Exploring the Map of Clinical Research for the Upcoming Decade"; December 12, 2000; Washington, DC.
14. Silverman DC, Yetman RJ. The care path not taken: the paradox of underused proven treatments. J Clin Outcomes Manage. 2001;8:39-51.
15. Sherwood LM. A second frontier: the physician's journey to outcome-oriented medicine. Weingarten S, Tinker J, eds. In: Evidence-Based Medicine. A Critical Assessment. London, England: Royal Society of Medicine Press; 2002:46-60.
16. Campbell E, Weissman JS, Moy E, Blumenthal D. Clinical research in academic health centers: views from the research leadership. JAMA. 2001;286:800-806.
17. Oinonen MJ, Crowley WF, Moskowitz J, Vlasses PH. How do academic health centers value and encourage clinical research? Acad Med. 2001;76:700-706.
18. Frist WH. Federal funding for biomedical research: commitment and benefits. JAMA. 2002;287:1722-1724.
19. Kroll JA, ed. An Industry in Evolution. Boston, Mass: CenterWatch; 2001.
20. Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL. Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials. 1997;18:328-352.
21. Gorkin L, Schron EB, Handshaw K, et al. Clinical trial enrollers vs nonenrollers: the Cardiac Arrhythmia Suppression Trial (CAST) Recruitment and Enrollment Assessment in Clinical Trials (REACT) project. Control Clin Trials. 1996;17:46-59.
22. Brescia BA. Budgeting and contracting in patient recruitment, In: Anderson DL. A Guide to Patient Recruitment. Boston, Mass: CenterWatch; 2001.
23. Wilson D, Heath D. Patients never knew the full danger of trials they staked their lives on. Seattle Times. March 11, 2001:A1.
24. Lemonick MD, Goldstein A. At your own risk. Time. 2002;159:46-56.
25. Gelijns AC, Thier SO. Medical innovation and institutional interdependence: rethinking university-industry connections. JAMA. 2002;287:72-77.
26. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflict of interest in biomedical research. JAMA. 2003;289:454-465.
27. Task Force on Financial Interests in Human Subjects Research. Protecting Subjects, Preserving Trust, Promoting Progress. Washington, DC: Association of American Medical Colleges; December 2001.
28. Task Force on Research Accountability, Association of American Universities. Report on Individual and Institutional Financial Conflict of Interest. Available at: http://www.aau.edu/research/COI.01.pdf. Accessed August 1, 2002.
29. Lee PY, Alexander KP, Hammill BG, Pasquali SK, Peterson ED. Representation of elderly persons and women in published randomized trials of acute coronary syndromes. JAMA. 2001;286:708-713.
30. National Institutes of Health. NIH guidelines on the inclusion of women and minorities as subjects in clinical research. 59 Federal Register 14508-14513 (1994).
31. US House of Representatives Report No. 209, 104th Cong, 1st Sess (1995).
32. US Senate Report No. 145, 104th Cong, 1st Sess (1995).
33. Giuliano AR, Mokuau N, Hughes C, et al. Participation of minorities in cancer research: the influence of structural, cultural, and linguistic factors. Ann Epidemiol. 2000;10(8 suppl):S22-S34.
34. Corbie-Smith G, Thomas SB, Williams MV, Moody-Ayers S. Attitudes and beliefs of African Americans toward participation in medical research. J Gen Intern Med. 1999;14:537-546.
35. Gifford AL, Cunningham WE, Heslin KC, et al. Participation in research and access to experimental treatments by HIV-infected patients. N Engl J Med. 2002;346:1373-1382.
36. Killien M, Bigby JA, Champion V, et al. Involving minority and underrepresented women in clinical trials: the National Centers of Excellence in Women's Health. J Womens Health Gend Based Med. 2000;9:1061-1070.
37. Green LW, Mercer SL. Can public health researchers and agencies reconcile the push from funding bodies and the pull from communities? Am J Public Health. 2001;91:1926-1929.
38. Centers for Disease Control and Prevention. Principles of Community Engagement. Atlanta, Ga: CDC Public Health Practice Program Office; 1997.
39. Entwistle VA, Renfrew MJ, Yearley S, Forrester J, Lamont T. Lay perspectives: advantages for health research. BMJ. 1998;316:463-466.
40. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: US Government Printing Office; 1979.
41. 45 CFR §46.111 (a)(4).
42. The Nuremberg Code. JAMA. 1996;276:1691.
43. Beauchamp TL, Childress J. The Principles of Biomedical Ethics. New York, NY: Oxford University Press; 1996.
44. Tait AR, Voepel-Lewis T, Robinson A, Malviya S. Priorities for disclosure of the elements of informed consent for research: a comparison between parents and investigators. Paediatr Anaesth. 2002;12:332-336.
45. Cox K. Informed consent and decision-making: patients' experiences of the process of recruitment to phases I and II anti-cancer drug trials. Patient Educ Couns. 2002;46:31-38.
46. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001;358:1772-1777.
47. 45 CFR 46.103.
48. Edgar H, Rothman D. The institutional review board and beyond. Milbank Q. 1995;73:489-506.
49. Wood A, Grady C, Emanuel EJ. The crisis in human participants research: identifying the problems and proposing solutions. Available at: http://www.bioethics.gov/emanuelpaper.html. Accessed January 23, 2003.
50. Evaluation of NIH implementation of section 491 of the Public Health Service Act, mandating a program of protection for research subjects. Review draft of final report. Bethesda, Md: Office of External Research, National Institutes of Health; May 1998. NIH contract N01-OD-2-2109.
51. Institutional Review Boards: A Time for Reform. Washington, DC: Office of Inspector General, US Dept of Health and Human Services; 1998. DHHS contract OEI-01-97-00193.
52. Final Report on Low-Volume Institutional Review Boards. Washington, DC: Office of Inspector General, US Dept of Health and Human Services; October 1998. DHHS contract OEI-01-97-00194.
53. Phillips DF. IRBs search for answers and support during a time of institutional change. JAMA. 2000;283:729-730.
54. Randal J. Examining IRBs: are review boards fulfilling their duties? J Natl Cancer Inst. 2001;93:1440-1441.
55. Christian MC, Goldberg JL, Killen J, et al. A central institutional review board for multi-institutional trials. N Engl J Med. 2002;346:1405-1408.
56. Multicenter Academic Clinical Research Organization (MACRO) home page. Available at: http://ccs.wustl.edu/macro/aboutmacro.htm. Accessed February 6, 2003.
57. Biomedical Research Alliance of New York (BRANY) home page. Available at: http://www.brany.com. Accessed February 6, 2003.
58. New national accrediting entity launched [press release]. Washington, DC: Association for the Accreditation of Human Research Protection Programs Inc; May 23, 2001. Available at: http://www.aahrpp .org/nr_05-23-01.htm. Accessed November 15, 2001.
59. How to access and comment on VA Human Research Protection Accreditation Program (VAHRPAP) draft standards, version 2.0. Available at: http://www.ncqa.org/Programs/QSG/VAHRPAP/vahrpapdraftstds.htm. Accessed July 19, 2002.
60. Standards for privacy of individually identifiable health information, 67 Federal Register 53182-53273 (2002) (codified at 45 CFR §160 and §164).
61. AAMC Comment Letter on Privacy NPRM. April 11, 2002. Available at: http://www.aamc.org/advocacy/library/hipaa/corres/2002/041102.htm. Accessed May 30, 2002.
62. Comments on proposed standards for privacy of individually identifiable health information. Washington, DC: Biotechnology Industry Organization; February 15, 2000. Available at: http://www.bio.org/laws/comments021700.html. Accessed May 31, 2002.
63. Gostin LO. Health Information: reconciling personal privacy with the public good of human health. Health Care Anal. 2001;9:321-335.
64. Olson LA, Peters SG, Steward JB. Security and confidentiality in an electronic medical record. Healthc Inf Manage. 1998;12:27-37.
65. Kaiser J. Researchers say rules are too restrictive. Science. 2001;294:2070-2071.
66. Annas GJ. Medical privacy and medical research: judging the new regulations. N Engl J Med. 2002;346:216-220.
67. Kian LA, Stewart MW, Bagby C, Robertson J. Justifying the cost of a computer-based patient record. Healthc Financ Manage. 1995;49:58-60.
68. Solovy A. The big payback: 2001 survey shows a healthy return on investment for info tech. Hosp Health Netw. 2001;75:40-50.
69. Henry D, Cooke S, Buckley P, et al. The Emerging Digital Economy II. Washington, DC: US Dept of Commerce; 1999. Available at: http://www.esa.doc .gov/508/esa/TheEmergingDigitalEconomyll.htm. Accessed February 12, 2001.
70. Margherio L, Henry D, Cooke S, Montes S. The Emerging Digital Economy. Washington, DC: US Dept of Commerce; 1998. Available at; http://www.esa.doc.gov/508/esa/TheEmergingDigitalEconomy .htm. Accessed February 12, 2001.
71. Raymond B, Dold C. Clinical Information Systems: Achieving the Vision. Oakland, Calif: Kaiser Permanente; 2002. Available at: http://www .kaiserpermanente.org/medicine/ihp/pdfs/raymond_feb_2002.pdf. Accessed February 12, 2003.
72. Wan TT, Lin BY, Ma A. Integration mechanisms and hospital efficiency in integrated health care delivery systems. J Med Syst. 2002;26:127-143.
73. Shine KI. Health care quality and how to achieve it. Acad Med. 2002;77:91-99.
74. Kaushal R, Barker KN, Bates DW. How can information technology improve patient safety and reduce medication errors in children's health care? Arch Pediatr Adolesc Med. 2001;155:1002-1007.
75. Marks RG, Conlon M, Ruberg SJ. Paradigm shifts in clinical trials enabled by information technology. Stat Med. 2001;20:2683-2696.
76. Johnson KB. Barriers that impede the adoption of pediatric information technology. Arch Pediatr Adolesc Med. 2001;155:1374-1379.
77. Shahar Y. Medical informatics: between science and engineering, between academia and industry. Methods Inf Med. 2002;41:8-11.
78. Brittain JM, Norris AC. Delivery of health informatics education and training. Health Libr Rev. 2000;17:117-128.
79. Sable JH, Hales JW, Bopp KD. Medical informatics in healthcare organizations: a survey of healthcare information managers. Proc AMIA Symp. 2000:744-748.
80. McDonald CJ, Schadow G, Suico J, Overhage JM. Data standards in health care. Ann Emerg Med. 2001;38:303-311.
81. Schiff GD, Rucker TD. Computerized prescribing: building the electronic infrastructure for better medical usage. JAMA. 1998;279:1024-1029.
82. Schiff GD, Aggarwal HC, Kumar S, McNutt RA. Prescribing potassium despite hyperkalemia: medication errors uncovered by linking laboratory and pharmacy information systems. Am J Med. 2000;109:494-497.
83. Information for Health: A Strategy for Building the National Health Information Infrastructure: Report and Recommendations from the National Committee on Vital and Health Statistics. Washington, DC: US Dept of Health and Human Services; November 15, 2001.
84. US Public Health Service. Making a Powerful Connection: The Health of the Public and the National Information Infrastructure. Available at: http:// www .nlm.nih.gov/pubs/staffpubs/lo/makingpd.html. Accessed February 12, 2002.
85. Zisson S. Anticipating a clinical investigator shortfall. CenterWatch. 2001;8:1.
86. Goldman E, Marshall E. NIH grantees: where have all the young ones gone? Science. 2002;298:40-41.
87. Zemlo TR, Garrison HH, Partridge NC, Ley TJ. The physidan-scientist: career issues and challenges at the year 2000. FASEB J. 2000;14:221-230.
88. Institute of Medicine. Resources for Clinical Investigation. Washington, DC: National Academy Press; 1988.
89. Ley TJ, Rosenberg LE. Removing career obstacles for young physician scientists: loan-repayment programs. N Engl J Med. 2002;346:368-372.
90. Nathan DG. Educational debt-relief for clinical investigators: a vote of confidence. N Engl J Med. 2002;346:372-374.
91. Association of American Medical Colleges. Medical school debt fact card. November 2002. Available at: http://www.aamc.org/students/financing/debthelp/factcard02.pdf. Accessed January 23, 2003.
92. Schrier RW. Ensuring the survival of the clinical scientist. Acad Med. 1997;72:589-594.
93. Nathan DG. Careers in translational clinical research: historical perspectives, future challenges. JAMA. 2002;287:2424-2427.
94. Moskowitz J, Thompson JN. Enhancing the clinical research pipeline: training approaches for a new century. Acad Med. 2001;76:307-315.
95. Pober JS, Neuhauser CS, Pober JM. Obstacles facing translational research in academic medical centers. FASEB J. 2001;15:2303-2313.
96. Griner PF, Blumenthal D. Reforming the structure and management of academic medical centers: case studies of ten institutions. Acad Med. 1998;73:818-825.
97. National Institutes of Health Office of Extramural Research. Information about NIH career development awards. Available at: http://grantsl.nih.gov/training/careerdevelopmentawards.htm. Accessed July 29, 2002.
98. Nathan DG, Varmus HE. The National Institutes of Health and clinical research: a progress report. Nat Med. 2000;6:1201-1204.
99. NIH Research Training Opportunities: K30 Clinical Research Curriculum Award. Available at: http://grants2.nih.gov/training/k3O.htm. Accessed February 11, 2003.
100. National Institutes of Health. NIH loan repayment programs. Available at: http://Irp.info.nih.gov/aib/aib1.htm. Accessed July 29, 2002.
101. National Institutes of Health Undergraduate Scholarship Program. Available at: http://ugsp.info.nih.gov/exesumfaq.htm. Accessed July 29, 2002.
102. NIH Clinical Loan Repayment Program. Available at: http://www.lrp.nih.gov/. Accessed January 23, 2003.
103. Egan L, Gallin E, Sung N. Debt repayment for trainees [letter]. N Engl J Med. 2002;436:2013.
104. Cech TR, Egan LW, Doyle C, et al. The biomedical research bottleneck. Science. 2001;293:573.
105. Field MJ, Tranquada RE, Feasley JC, eds. Health Services Research: Work Force and Educational Issues. Washington, DC: National Academy Press; 1995.
106. Guyatt GH, Haynes RB, Jaeschke RZ, et al. Users' guides to the medical literature, XXV: evidence-based medicine: principles for applying the users' guides to patient care. JAMA. 2000;284:1290-1296.
107. Physician Consortium for Performance Improvement. Core physician performance measurement sets; December 17, 2002. Available at: http://www.ama-assn.org/ama/pub/category/4837.html. Accessed January 23, 2003.
108. Cochrane Collaboration home page. Available at: http://www.cochrane.org. Accessed January 23, 2003.
109. Shoichet CE. Nurses needed. Chronicle of Higher Education. August 2, 2002. Available at: http://chronicle.com/weekly/v48/i47/47a03001.htm. Accessed July 29, 2002.
110. Johnson and Johnson Discover Nursing campaign. Available at: http://www.discovernursing.com. Accessed July 30, 2002.
111. Final congressional action: House, Senate pass Nurse Reinvestment Act; VA nurse bill cleared for president's signature. Available at: http://www .nursingworld.org/gova/federal/news/reinvest.htm. Accessed July 20, 2002.
112. Kelley WN, Randolph MA, eds. Careers in Clinical Research: Obstacles and Opportunities. Washington, DC: National Academy Press; 1994:240-242, 260.
113. NIH competing and noncompeting research grants, fiscal years 1992-2002. Available at: http://grants.nih .gov/grants/award/research/rgmechtype9202.htm. Accessed February 12, 2003.
114. NIH competing and noncompeting awards, FY 2001. Available at: http://grants.nih.gov/grants/award/trends/compawds01.htm. Accessed May 31, 2002.
115. National Center for Research Resources: Clinical Research; 2003. Available at: http://www.ncrr.nih.gov/clinical_rsrch.asp. Accessed February 12, 2003.
116. The NIH Director's Panel on Clinical Research report to the Advisory Committee to the NIH Director, December 1997. Available at: http://www.nih.gov/news/crp/97report/index.htm. Accessed February 12, 2003.
117. Helms D. Stakeholders and funding for health services research. Presented at: National Academy of Sciences Clinical Research Roundtable; June 12, 2002; Washington, DC.
118. Clinical Evidence home page. Available at: http://www.clinicalevidence.org. Accessed February 12, 2003.
119. Chalmers I, Hedges LV, Cooper H. A brief history of research synthesis. Eval Health Prof. 2002;25:12-37.
120. Pharmaceutical Research and Manufacturers of America 2002 Industry Profile. Available at: http://www.phrma.org/publications/publications/profile02/index.cfm. Accessed July 25, 2001.
121. An Industry in Evolution. Boston, Mass: CenterWatch; 2001:49.
122. Nelson AF, Quiter ES, Solberg LI. The state of research within managed care plans: 1997 survey. Health Aff (Millwood). 1998;17:128-138.
123. Grantmakers in Health. Assets for Health: Findings From the 2001 Survey of New Health Foundations. March 2002. Available at: http://www.gih.org/usr_doc/200120Conversion20Report.pdf. Accessed May 31, 2002.