Task force 2: Investigator participation in clinical research

Journal of the American College of Cardiology

Volumn 44, Issue 8, 2004, Pages 1729-1736

  Califf, Robert M ^a   Nissen, Steven E ^a   Demaria, Anthony N ^a   Ohman, Erik Magnus ^a   Pitt, Bertram ^a   Willerson, James T ^a   Bilheimer, David W ^a   Cohn, Jay N ^a   Feigal Jr , David W ^a   Hampson, Lindsay ^a   Lorell, Beverly H ^a   Pepine, Carl J ^a   Popp, Richard L ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

CARDIOVASCULAR DISEASE; CONFERENCE PAPER; DIAGNOSTIC PROCEDURE; DOCTOR PATIENT RELATION; HEALTH CARE INDUSTRY; HEALTH CARE ORGANIZATION; MEDICAL ETHICS; MEDICAL PRACTICE; MEDICAL PROFESSION; PATIENT CARE; PRIORITY JOURNAL; STATISTICAL ANALYSIS;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

ADVISORY COMMITTEES; CARDIOVASCULAR DISEASES; CLINICAL TRIALS; CONFLICT OF INTEREST; DATA COLLECTION; ETHICS, MEDICAL; HUMANS; RESEARCH DESIGN; SOCIETIES, MEDICAL; UNITED STATES;

EID: 5644304357     PISSN: 07351097     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jacc.2004.08.039     Document Type: Conference Paper

References (31)

1. C.J. Murray, A.D. Lopez Mortality by cause for eight regions of the world: Global Burden of Disease Study Lancet 349 1997 1269 1276
2. D.R. Holmes Jr., B.G. Firth, A James Conflict of interest Am Heart J 147 2004 228 237
3. T.R. Fleming, S. Ellenberg, D.L. DeMets Monitoring clinical trials: issues and controversies regarding confidentiality Stat Med 21 2002 2843 2851
4. Code of Ethics on Interaction with Health Care Professionals. Available at: www.advamed.org. Last update July 13, 2004. Accessed September 22, 2004.
5. L. Smith, J.F. Byers Gene therapy in the post-Gelsinger era JONAS Healthcare Law Ethics Regul 4 2002 104 110
6. The AAMC Task Force Protecting subjects, preserving trust, promoting progress II: principles and recommendations for oversight of an institution's financial interests in human subjects' research Acad Med 78 2003 237 245
7. Horton R. The Dawn of McScience. The New York Review of Books. The New York Times 2004;51:4.
8. The World Medical Association World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects 2004 World Medical Association Ferney-Voltaire, France 1-5
9. The World Medical Association Declaration of Geneva (1948) 2004 World Medical Association Ferney-Voltaire, France
10. W.J. Smith Revisiting the Belmont report Hastings Cent Rep 31 2001 5
11. R.L. Goodson Good clinical practices: past, present, and future Qual Assur 4 1995 60 67
12. The Food and Drug Administration International Conference on Harmonization, Good clinical practice: consolidated guideline, notice of availability Fed Regist 62 1997 25691 25709
13. C. Lenfant Shattuck lecture - clinical research to clinical practice - lost in translation? N Engl J Med 349 2003 868 874
14. H. Moses III, E. Braunwald, J.B. Martin, S.O. Thier Collaborating with industry - choices for the academic medical center N Engl J Med 347 2002 1371 1375
15. Popp RL. Conflict of interest for the physician-inventor using a device in human subjects. Am Heart J 2004. In press.
16. The AAMC Task Force AAMC Task Force issues first financial conflict of interest guidelines, and GAO urges HHS to reexamine financial conflict of interest guidance and regulations for NIH-funded research Association of American Medical Colleges. U.S. General Accounting Office. Department of Health and Human Services J Investig Med 50 2002 82 83
17. Protecting subjects, preserving trust, promoting progress I: policy and guidelines for the oversight of individual financial interests in human subjects' research Acad Med 78 2003 225 236
18. K.A. Schulman, D.M. Seils, J.W Timbie A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors N Engl J Med 347 2002 1335 1341
19. K. Dickersin The existence of publication bias and risk factors for its occurrence JAMA 263 1990 1385 1389
20. K. Dickersin, Y.I. Min, C.L. Meinert Factors influencing publication of research results Follow-up of applications submitted to two institutional review boards JAMA 267 1992 374 378
21. M. Bhandari, J.W. Busse, D Jackowski Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials CMAJ 170 2004 477 480
22. A.S. Relman, M. Angell America's other drug problem: how the drug industry distorts medicine and politics New Repub 227 2002 27 41
23. M.K. Krzyzanowska, M. Pintilie, I.F. Tannock Factors associated with failure to publish large randomized trials presented at an oncology meeting JAMA 290 2003 495 501
24. K. Dickersin, D. Rennie Registering clinical trials JAMA 290 2003 516 523
25. J.B. Hrachovec, M. Mora Reporting of 6-month vs. 12-month data in a clinical trial of celecoxib JAMA 286 2001 2398 2400
26. T. McKillop The statin wars Lancet 362 2003 1498
27. D.G. Nathan, D.J. Weatherall Academia and industry: lessons from the unfortunate events in Toronto Lancet 353 1999 771 772
28. International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. Available at: www.icmje.org/index.html#conflicts.
29. P.L. 96-517; 94 Stat. 3015 The Bayh-Dole Act. 12-12-1980.
30. S.G. Stolberg The biotech death of Jesse Gelsinger NY Times Magazine 1999 136 150
31. R.M. Califf, M.A. Morse, J Wittes Toward protecting the safety of participants in clinical trials Control Clin Trials 24 2003 256 271