Clinical practice is changing rapidly. New cardiovascular drugs,antiinflammatory drugs, cancer chemotherapy, and other pharmacologicweapons are being added to physicians' therapeutic armamentariumvirtually daily. Most clinical studies that bring new drugsfrom bench to bedside are financed by pharmaceutical companies.Many of these drug trials are rigorously designed, employingthe skills of outstanding clinical researchers at leading academicinstitutions.
But academic medical centers are no longer the sole citadelsof clinical research. The past 10 years have seen the spectaculargrowth of a new research model. Commercially oriented networksof contract-research organizations (CROs) and site-managementorganizations (SMOs) have altered . . . [Full Text of this Article]
The Clinical-Drug-Trial System
The Shift to Commercial Drug Networks
Industry–Investigator Relationships
Trial Design
Data Analysis
Publishing the Results
Control over Publication
Authorship
Conclusions
References
Related Letters:
Is Academic Medicine for Sale?
Ross L. F., Norton J. W., Young S. A., Lebowitz J., Leong G. B., Silva J. A., Dillon D. C., Jagger J., Firlik A. D., Lowry D. W., Diamond C., Ruane T. J., Hagan B. M., Miller P. D., Angell M.
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N Engl J Med 2000;
343:508-510, Aug 17, 2000.
Correspondence
Buchanan, D., Sifunda, S., Naidoo, N., James, S., Reddy, P.
(2008). Assuring Adequate Protections in International Health Research: A Principled Justification and Practical Recommendations for the Role of Community Oversight. Public Health Ethics
0: phn027v1-phn027
[Abstract][Full Text]
Hartley, H., Coleman, C.-L.
(2008). News media coverage of direct-to-consumer pharmaceutical advertising: implications for countervailing powers theory. Health (London)
12: 107-132
[Abstract]
Campbell, E. G., Weissman, J. S., Ehringhaus, S., Rao, S. R., Moy, B., Feibelmann, S., Goold, S. D.
(2007). Institutional Academic Industry Relationships. JAMA
298: 1779-1786
[Abstract][Full Text]
Sernyak, M., Rosenheck, R.
(2007). Experience of VA Psychiatrists With Pharmaceutical Detailing of Antipsychotic Medications. Psychiatr. Serv.
58: 1292-1296
[Abstract][Full Text]
Iserson, K. V., Cerfolio, R. J., Sade, R. M.
(2007). Politely Refuse the Pen and Note Pad: Gifts From Industry to Physicians Harm Patients. Ann. Thorac. Surg.
84: 1077-1084
[Full Text]
Parascandola, M.
(2007). A Turning Point for Conflicts of Interest: The Controversy Over the National Academy of Sciences' First Conflicts of Interest Disclosure Policy. JCO
25: 3774-3779
[Abstract][Full Text]
Gray, S. W., Hlubocky, F. J., Ratain, M. J., Daugherty, C. K.
(2007). Attitudes Toward Research Participation and Investigator Conflicts of Interest Among Advanced Cancer Patients Participating in Early Phase Clinical Trials. JCO
25: 3488-3494
[Abstract][Full Text]
Tungaraza, T., Poole, R.
(2007). Influence of drug company authorship and sponsorship on drug trial outcomes. Br. J. Psychiatry
191: 82-83
[Abstract][Full Text]
Friedman, J. Y, Sugarman, J., Dhillon, J. K, DePuy, V., Pierre, C. K, Dinan, M. A, Allsbrook, J. S, Schulman, K. A, Weinfurt, K. P
(2007). Perspectives of clinical research coordinators on disclosing financial conflicts of interest to potential research participants. Clin Trials
4: 272-278
[Abstract]
Shea, A. M., DePuy, V., Allen, J. M., Weinfurt, K. P.
(2007). Use and Perceptions of Clinical Practice Guidelines by Internal Medicine Physicians. American Journal of Medical Quality
22: 170-176
[Abstract]
Campbell, E. G., Gruen, R. L., Mountford, J., Miller, L. G., Cleary, P. D., Blumenthal, D.
(2007). A National Survey of Physician-Industry Relationships. NEJM
356: 1742-1750
[Abstract][Full Text]
Okike, K., Kocher, M. S.
(2007). The Legal and Ethical Issues Surrounding Financial Conflict of Interest in Orthopaedic Research. JBJS
89: 910-913
[Full Text]
Okike, K., Kocher, M. S., Mehlman, C. T., Bhandari, M.
(2007). Conflict of Interest in Orthopaedic Research. An Association Between Findings and Funding in Scientific Presentations. JBJS
89: 608-613
[Abstract][Full Text]
Brody, H., Hunt, L. M.
(2006). BiDil: Assessing a Race-Based Pharmaceutical. Ann Fam Med
4: 556-560
[Abstract][Full Text]
Hilbrich, L., Sleight, P.
(2006). Progress and problems for randomized clinical trials: from streptomycin to the era of megatrials. Eur Heart J
27: 2158-2164
[Abstract][Full Text]
Grady, C., Horstmann, E., Sussman, J. S., Hull, S. C.
(2006). The Limits of Disclosure: What Research Subjects Want to Know about Investigator Financial Interests. J Law Med Ethics
34: 592-599
Mintzberg, H.
(2006). Patent nonsense: Evidence tells of an industry out of social control.. CMAJ
175: 374-374
[Full Text]
Hartley, H.
(2006). The 'Pinking' of Viagra Culture: Drug Industry Efforts to Create and Repackage Sex Drugs for Women. Sexualities
9: 363-378
[Abstract]
McHenry, L
(2006). Ethical issues in psychopharmacology.. J. Med. Ethics
32: 405-410
[Abstract][Full Text]
Brown, S. D., Daly, J. C., Kalish, L. A., McDaniel, S. A.
(2006). Financial Disclosures of Scientific Papers Presented at the 2003 RSNA Annual Meeting: Association with Reporting of Non-Food and Drug Administration-approved Uses of Industry Products. Radiology
239: 849-855
[Abstract][Full Text]
Ridker, P. M, Torres, J.
(2006). Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005.. JAMA
295: 2270-2274
[Abstract][Full Text]
Busfield, J.
(2006). Pills, Power, People: Sociological Understandings of the Pharmaceutical Industry. Sociology
40: 297-314
[Abstract]
Tarrier, N.
(2006). Negative Symptoms in Schizophrenia: Comments From a Clinical Psychology Perspective. Schizophr Bull
32: 231-233
[Abstract][Full Text]
Heres, S., Davis, J., Maino, K., Jetzinger, E., Kissling, W., Leucht, S.
(2006). Why Olanzapine Beats Risperidone, Risperidone Beats Quetiapine, and Quetiapine Beats Olanzapine: An Exploratory Analysis of Head-to-Head Comparison Studies of Second-Generation Antipsychotics. Am. J. Psychiatry
163: 185-194
[Abstract][Full Text]
Henry, D., Doran, E., Kerridge, I., Hill, S., McNeill, P. M., Day, R.
(2005). Ties That Bind: Multiple Relationships Between Clinical Researchers and the Pharmaceutical Industry. Arch Intern Med
165: 2493-2496
[Abstract][Full Text]
Stossel, T. P.
(2005). Regulating Academic-Industrial Research Relationships -- Solving Problems or Stifling Progress?. NEJM
353: 1060-1065
[Full Text]
Sierles, F. S., Brodkey, A. C., Cleary, L. M., McCurdy, F. A., Mintz, M., Frank, J., Lynn, D. J., Chao, J., Morgenstern, B. Z., Shore, W., Woodard, J. L.
(2005). Medical Students' Exposure to and Attitudes About Drug Company Interactions: A National Survey. JAMA
294: 1034-1042
[Abstract][Full Text]
Abramson, J., Starfield, B.
(2005). The Effect of Conflict of Interest on Biomedical Research and Clinical Practice Guidelines: Can We Trust the Evidence in Evidence-Based Medicine?. J Am Board Fam Med
18: 414-418
[Full Text]
Genuis, S. J.
(2005). The Proliferation of Clinical Practice Guidelines: Professional Development or Medicine-by-Numbers?. J Am Board Fam Med
18: 419-425
[Abstract][Full Text]
Mirowski, P., Van Horn, R.
(2005). The Contract Research Organization and the Commercialization of Scientific Research. Social Studies of Science
35: 503-548
[Abstract]
Hartling, L., McAlister, F. A., Rowe, B. H., Ezekowitz, J., Friesen, C., Klassen, T. P.
(2005). Challenges in Systematic Reviews of Therapeutic Devices and Procedures. ANN INTERN MED
142: 1100-1111
[Abstract][Full Text]
Mohl, P. C.
(2005). Psychiatric Training Program Engagement With the Pharmaceutical Industry: An Educational Issue, Not Strictly an Ethical One. Acad. Psychiatry
29: 215-221
[Abstract][Full Text]
Brodkey, A. C.
(2005). The Role of the Pharmaceutical Industry in Teaching Psychopharmacology: A Growing Problem. Acad. Psychiatry
29: 222-229
[Abstract][Full Text]
Spitz, B., Abramson, J.
(2005). When Health Policy Is the Problem: A Report from the Field. Journal of Health Politics, Policy and Law
30: 327-366
[Abstract]
Mello, M. M., Clarridge, B. R., Studdert, D. M.
(2005). Academic Medical Centers' Standards for Clinical-Trial Agreements with Industry. NEJM
352: 2202-2210
[Abstract][Full Text]
Ryan, T. J., DeSanctis, R. W.
(2005). Dr Jerome Kassirer's Book On The Take: How Medicine's Complicity With Big Business Can Endanger Your Health: Worthy of Comment. Circulation
111: 2552-2554
[Full Text]
Snyder, L., Leffler, C., for the Ethics and Human Rights Committee, America,
(2005). Ethics Manual: Fifth Edition. ANN INTERN MED
142: 560-582
[Abstract][Full Text]
Foladori, G.
(2005). The Challenge of Infectious Diseases to the Biomedical Paradigm. Bulletin of Science Technology Society
25: 145-158
[Abstract]
Kavanaugh, A
(2005). Ethical and practical issues in conducting clinical trials in psoriasis and psoriatic arthritis. Ann Rheum Dis
64: ii46-ii48
[Abstract][Full Text]
Beecher, N., Harrison, E., Goldstein, N., McDaniel, M., Field, P., Susskind, L.
(2005). Risk Perception, Risk Communication, and Stakeholder Involvement for Biosolids Management and Research. J. Environ. Qual.
34: 122-128
[Abstract][Full Text]
Lexchin, J. R
(2005). Implications of Pharmaceutical Industry Funding on Clinical Research. The Annals of Pharmacotherapy
39: 194-197
[Abstract][Full Text]
King, T. E. Jr, Wheeler, M. B.
(2004). Inequality in Health Care: Unjust, Inhumane, and Unattended!. ANN INTERN MED
141: 815-817
[Full Text]
Studdert, D. M., Mello, M. M., Brennan, T. A.
(2004). Financial Conflicts of Interest in Physicians' Relationships with the Pharmaceutical Industry -- Self-Regulation in the Shadow of Federal Prosecution. NEJM
351: 1891-1900
[Full Text]
Freemantle, N., Stocken, D.
(2004). The commercialization of clinical research: who pays the piper, calls the tune?. Fam Pract
21: 335-336
[Full Text]
Taekman, J. M., Hobbs, G., Barber, L., Phillips-Bute, B. G., Wright, M. C., Newman, M. F., Stafford-Smith, M.
(2004). Preliminary Report on the Use of High-Fidelity Simulation in the Training of Study Coordinators Conducting a Clinical Research Protocol. Anesth. Analg.
99: 521-527
[Abstract][Full Text]
Beal, K., Dean, J., Chen, J., Dragaon, E., Saulino, A., Collard, C. D.
(2004). Budget Negotiation for Industry-Sponsored Clinical Trials. Anesth. Analg.
99: 173-176
[Abstract][Full Text]
Helft, P. R., Ratain, M. J., Epstein, R. A., Siegler, M.
(2004). Inside Information: Financial Conflicts of Interest for Research Subjects in Early Phase Clinical Trials. JNCI J Natl Cancer Inst
96: 656-661
[Abstract][Full Text]
Buchkowsky, S. S, Jewesson, P. J
(2004). Industry Sponsorship and Authorship of Clinical Trials Over 20 Years. The Annals of Pharmacotherapy
38: 579-585
[Abstract][Full Text]
Schafer, A
(2004). Biomedical conflicts of interest: a defence of the sequestration thesis--learning from the cases of Nancy Olivieri and David Healy. J. Med. Ethics
30: 8-24
[Abstract][Full Text]
DuVal, G
(2004). Institutional ethics review of clinical study agreements. J. Med. Ethics
30: 30-34
[Abstract][Full Text]
Kim, S Y H, Millard, R W, Nisbet, P, Cox, C, Caine, E D
(2004). Potential research participants' views regarding researcher and institutional financial conflicts of interest. J. Med. Ethics
30: 73-79
[Abstract][Full Text]
Currie, C.
(2003). Clinical arithmetic. BMJ
327: 1418-1419
[Full Text]
Kappos, L, Polman, C, Thompson, A J, Duda, P, Clanet, M, Comi, G, Hartung, H P, Montalban, X
(2003). Towards a European Network for Multiple Sclerosis Trials (ENMST). Mult Scler
9: 627-629
[Abstract]
Bola, J. R.
(2003). Integrity and bias in academic psychiatry. Br. J. Psychiatry
183: 464-464
[Full Text]
Bottomley, A., Efficace, F., Thomas, R., Vanvoorden, V., Ahmedzai, S. H.
(2003). Health-Related Quality of Life in Non-Small-Cell Lung Cancer: Methodologic Issues in Randomized Controlled Trials. JCO
21: 2982-2992
[Abstract][Full Text]
COOPER, B.
(2003). Evidence-based mental health policy: a critical appraisal. Br. J. Psychiatry
183: 105-113
[Abstract][Full Text]
Staropoli, J. F.
(2003). Funding and Practice of Biomedical Research. JAMA
290: 112-112
[Full Text]
Chopra, S. S.
(2003). Industry Funding of Clinical Trials: Benefit or Bias?. JAMA
290: 113-114
[Full Text]
Rosen, G. M., Davison, G. C.
(2003). Psychology Should List Empirically Supported Principles of Change (ESPs) and Not Credential Trademarked Therapies or Other Treatment Packages. Behav Modif
27: 300-312
[Abstract]
LAGNADO, M.
(2003). Increasing the trust in scientific authorship. Br. J. Psychiatry
183: 3-4
[Full Text]
Baird, P.
(2003). Getting it right: industry sponsorship and medical research. CMAJ
168: 1267-1269
[Full Text]
Miller, F. G., Rosenstein, D. L.
(2003). The Therapeutic Orientation to Clinical Trials. NEJM
348: 1383-1386
[Full Text]
Steinman, M. A., Gonzales, R., Linder, J. A., Landefeld, C. S.
(2003). Changing Use of Antibiotics in Community-Based Outpatient Practice, 1991-1999. ANN INTERN MED
138: 525-533
[Abstract][Full Text]
Bekelman, J. E., Li, Y., Gross, C. P.
(2003). Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review. JAMA
289: 454-465
[Abstract][Full Text]
Schulman, K. A., Seils, D. M., Timbie, J. W., Sugarman, J., Dame, L. A., Weinfurt, K. P., Mark, D. B., Califf, R. M.
(2002). A National Survey of Provisions in Clinical-Trial Agreements between Medical Schools and Industry Sponsors. NEJM
347: 1335-1341
[Abstract][Full Text]
Relman, A. S., Bittl, J. A., Ferris, L. E., Korenman, S. K., Drazen, J. M., Curfman, G. D.
(2002). Financial Associations of Authors. NEJM
347: 1043-1044
[Full Text]
Barnes, M., Florencio, P. S.
(2002). Financial Conflicts of Interest in Human Subjects Research: The Problem of Institutional Conflicts. J Law Med Ethics
30: 390-402
Kennedy, H. L., Rosenson, R. S.
(2002). Physicians' interpretation of "class effects": A need for thoughtful re-evaluation. J Am Coll Cardiol
40: 19-26
[Abstract][Full Text]
(2002). The invisible hand of the marketing department. CMAJ
167: 5-5
[Full Text]
(2002). La main invisible du marketing. CMAJ
167: 7-7
[Full Text]
(2002). Scientific Data from Clinical Trials: Investigators' Responsibilities and Rights. Ann. Surg. Oncol.
9: 421-422
[Full Text]
Caulfield, T., Griener, G.
(2002). Conflicts of Interest in Clinical Research: Addressing the Issue of Physician Remuneration. J Law Med Ethics
30: 305-308
(2002). Scientific Data From Clinical Trials: Investigators' Responsibilities and Rights. Arch Surg
137: 639-640
[Full Text]
Zwart-van Rijkom, J.E.F., Broekmans, F.J., Leufkens, H.G.M.
(2002). From HMG through purified urinary FSH preparations to recombinant FSH: a substitution study. Hum Reprod
17: 857-865
[Abstract][Full Text]
Miller, F. G., Shorr, A. F.
(2002). Ethical Assessment of Industry-Sponsored Clinical Trials* : A Case Analysis. Chest
121: 1337-1342
[Abstract][Full Text]
Alpert, J. S., Furman, S., Smaha, L.
(2002). Conflicts of Interest: Science, Money, and Health. Arch Intern Med
162: 635-637
[Full Text]
Lenzer, J., Warlow, C., Saver, J. L, Kidwell, C. S, Starkman, S.
(2002). Alteplase for stroke: money and optimistic claims buttress the "brain attack" campaign * Commentary: Who pays the guideline writers? * Commentary: Thrombolysis in stroke: it works!. BMJ
324: 723-729
[Full Text]
Coyle, S. L., for the Ethics and Human Rights Committee, America,
(2002). Physician-Industry Relations. Part 1: Individual Physicians. ANN INTERN MED
136: 396-402
[Abstract][Full Text]
Nagy-Agren, S.
(2002). The Crisis in Local Institutional Review Boards. ANN INTERN MED
136: 410-411
[Full Text]
Carpenter, W. T. Jr
(2002). From Clinical Trial to Prescription. Arch Gen Psychiatry
59: 282-285
[Abstract][Full Text]
Morin, K., Rakatansky, H., Riddick, F. A. Jr, Morse, L. J., O'Bannon III, J. M., Goldrich, M. S., Ray, P., Weiss, M., Sade, R. M., Spillman, M. A.
(2002). Managing Conflicts of Interest in the Conduct of Clinical Trials. JAMA
287: 78-84
[Abstract][Full Text]
Kalb, P. E., Koehler, K. G.
(2002). Legal Issues in Scientific Research. JAMA
287: 85-91
[Abstract][Full Text]
Anderson, J.
(2001). The Francois Rabelais School of Medicine. BMJ
323: 1456-1457
[Full Text]
Abzug, M. J., Esterl, E. A.
(2001). Establishment of a Clinical Trials Office at a Children's Hospital. Pediatrics
108: 1129-1134
[Abstract][Full Text]
Fenster;, D. L., Winner, P.
(2001). Migraine Treatment. Pediatrics
108: 817-817
[Abstract][Full Text]
DeAngelis, C. D., Fontanarosa, P. B., Flanagin, A.
(2001). Reporting Financial Conflicts of Interest and Relationships Between Investigators and Research Sponsors. JAMA
286: 89-91
[Full Text]
Jones, T. C
(2001). Call for a new approach to the process of clinical trials and drug registration. BMJ
322: 920-923
[Full Text]
Drueke, T. B., Lameire, N.
(2001). Report from the Editorial Office. Nephrol Dial Transplant
16: 29-31
[Full Text]
Lo, B., Wolf, L. E., Berkeley, A.
(2000). Conflict-of-Interest Policies for Investigators in Clinical Trials. NEJM
343: 1616-1620
[Abstract][Full Text]
McCrary, S. V., Anderson, C. B., Jakovljevic, J., Khan, T., McCullough, L. B., Wray, N. P., Brody, B. A.
(2000). A National Survey of Policies on Disclosure of Conflicts of Interest in Biomedical Research. NEJM
343: 1621-1626
[Abstract][Full Text]
Martin, J. B., Kasper, D. L.
(2000). In Whose Best Interest? Breaching the Academic-Industrial Wall. NEJM
343: 1646-1649
[Full Text]
Cho, M. K., Shohara, R., Schissel, A., Rennie, D.
(2000). Policies on Faculty Conflicts of Interest at US Universities. JAMA
284: 2203-2208
[Abstract][Full Text]
Boyd, E. A., Bero, L. A.
(2000). Assessing Faculty Financial Relationships With Industry: A Case Study. JAMA
284: 2209-2214
[Abstract][Full Text]
Ross, L. F., Norton, J. W., Young, S. A., Lebowitz, J., Leong, G. B., Silva, J. A., Dillon, D. C., Jagger, J., Firlik, A. D., Lowry, D. W., Diamond, C., Ruane, T. J., Hagan, B. M., Miller, P. D., Angell, M.
(2000). Is Academic Medicine for Sale?. NEJM
343: 508-510
[Full Text]
Newman, T. J., Bellin, E., Bodenheimer, T.
(2000). Clinical Investigators and the Pharmaceutical Industry. NEJM
343: 510-511
[Full Text]
Angell, M.
(2000). Is Academic Medicine for Sale?. NEJM
342: 1516-1518
[Full Text]
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