Why we need easy access to all data from all clinical trials and how to accomplish it

Trials

Volumn 12, Issue , 2011, Pages

  Gøtzsche, Peter C ^a  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; ANTIDEPRESSANT AGENT; APROTININ; CELECOXIB; MONOCLONAL ANTIBODY; MURAGLITAZAR; OSELTAMIVIR; PIOGLITAZONE; PLACEBO; REBOXETINE; ROFECOXIB; ROSIGLITAZONE; VALDECOXIB;

ACCESS TO INFORMATION; ADVERTIZING; BACTERIAL PNEUMONIA; BLEEDING; BLOOD CLOT LYSIS; CARDIOVASCULAR DISEASE; CLINICAL TRIAL (TOPIC); COHORT ANALYSIS; COLON SURGERY; COST EFFECTIVENESS ANALYSIS; DATA ANALYSIS; DECISION MAKING; DEPRESSION; DIGESTIVE SYSTEM ULCER; DRUG FATALITY; DRUG INDUSTRY; DRUG LEGISLATION; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE PERSONNEL; HEALTH CARE PLANNING; HEALTH PRACTITIONER; HEART DISEASE; HEART INFARCTION; HOSPITAL ADMISSION; HUMAN; HUMAN RIGHTS ABUSE; HYPOTHESIS; INCOME; INFLUENZA; INFORMATION PROCESSING; INTENSIVE CARE UNIT; LETHALITY; LOWEST INCOME GROUP; MEDICAL DEVICE; MEDICAL ETHICS; MEDICAL RESEARCH; MENTAL INSTABILITY; META ANALYSIS; MULTIPLE ORGAN FAILURE; NATIONAL HEALTH ORGANIZATION; NOTE; PHASE 1 CLINICAL TRIAL (TOPIC); PUBLIC HEALTH SERVICE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SCIENTIST; STATISTICAL ANALYSIS; SUICIDAL BEHAVIOR; SUICIDE ATTEMPT; TREATMENT FAILURE; WORLD HEALTH ORGANIZATION; ARTICLE; DRUG CONTROL; INFORMATION DISSEMINATION;

CLINICAL TRIALS AS TOPIC; DATA COLLECTION; DRUG AND NARCOTIC CONTROL; DRUG INDUSTRY; HUMANS; INFLUENZA, HUMAN; INFORMATION DISSEMINATION; OSELTAMIVIR;

EID: 84856026510     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-12-249     Document Type: Note

References (141)

1. The Cochrane Library. , http://www.thecochranelibrary.com/view/0/index.html
2. Gøtzsche PC. Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal, anti-inflammatory drugs in rheumatoid arthritis. Control Clin Trials 1989, 10:31-56. (amendment:356), 10.1016/0197-2456(89)90017-2, 2702836.
3. Gøtzsche PC. Bias in double-blind trials. Dan Med Bull 1990, 37:329-36.
4. Bero LA, Rennie D. Influences on the quality of published drug studies. Int J Technol Assess Health Care 1996, 12:209-237. 10.1017/S0266462300009582, 8707496.
5. Safer DJ. Design and reporting modifications in industry-sponsored comparative psychopharmacology trials. J Nerv Ment Dis 2002, 190:583-592. 10.1097/00005053-200209000-00002, 12357091.
6. Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B. Evidence b(i)ased medicine - selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003, 326:1171-1173. 10.1136/bmj.326.7400.1171, 156459, 12775615.
7. Bero L, Oostvogel F, Bacchetti P, Lee K. Factors associated with findings of published trials of drug-drug comparisons: Why some statins appear more efficacious than others. PLoS Med 2007, 4:e184. 10.1371/journal.pmed.0040184, 1885451, 17550302.
8. Johansen HK, Gøtzsche PC. Problems in the design and reporting of trials of antifungal agents encountered during meta-analysis. JAMA 1999, 282:1752-1759. 10.1001/jama.282.18.1752, 10568648.
9. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008, 358:252-260. 10.1056/NEJMsa065779, 18199864.
10. Rising K, Bacchetti P, Bero. Reporting bias in drug trials submitted to the Food and Drug Administration: a review of publication and presentation. PLoS Med 2008, 5:e217. 10.1371/journal.pmed.0050217, 2586350, 19067477.
11. Healy D. Let them eat Prozac 2004, New York: New York University Press.
12. Fournier JC, DeRubeis RJ, Hollon SD, Dimidjian S, Amsterdam JD, Shelton RC, Fawcett J. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA 2010, 303:47-53. 10.1001/jama.2009.1943, 20051569.
13. Furukawa TA. All clinical trials must be reported in detail and made publicly available. BMJ 2004, 329:626. 516671, 15361465.
14. Healy D. Did regulators fail over selective serotonin reuptake inhibitors?. BMJ 2006, 333:92-95. 10.1136/bmj.333.7558.92, 1489234, 16825234.
15. Kendall T, McGoey L, Jackson E. If NICE was in the USA. Lancet 2009, 374:272-273. 10.1016/S0140-6736(09)60781-9, 19394077.
16. Chan A-W, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004, 291:2457-2465. 10.1001/jama.291.20.2457, 15161896.
17. Chan AW, Krleza-Jerić K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ 2004, 171:735-740. 10.1503/cmaj.1041086, 517858, 15451835.
18. Chan A-W, Hróbjartsson A, Jørgensen KJ, Gøtzsche PC, Altman DG. Reporting of sample size calculations and data analysis methods in randomized trials: comparison of publications with protocols. BMJ 2008, 337:1404-1407.
19. Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K. Publication bias in clinical trials due to statistical significance or direction of trial results. Cochrane Database Syst Rev 2009, (1). Art. No.: MR000006.
20. Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med 2009, 361:1963-1971. 10.1056/NEJMsa0906126, 19907043.
21. Jureidini JN, McHenry LB, Mansfield PR. Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Safety Med 2008, 20:73-81.
22. McCormack K, Scott N, Grant A. Outcome reporting bias and individual patient data meta-analysis: a case study in surgery. 9th International Cochrane Colloquium: 9-13 Oct 2001; Lyon, France 34. abstract P-005.
23. Moore TJ. Deadly medicine: why tens of thousands of heart patients died in America's worst drug disaster 1995, New York: Simon & Schuster.
24. Cowley AJ, Skene A, Stainer K, Hampton JR. The effect of lorcainide on arrhythmias and survival in patients with acute myocardial infarction: an example of publication bias. Int J Cardiol 1993, 40:161-166. 10.1016/0167-5273(93)90279-P, 8349379.
25. Lenzer J. FDA is incapable of protecting US "against another Vioxx". BMJ 2004, 329:1253. 10.1136/bmj.329.7477.1253, 534432, 15564236.
26. Topol EJ. Failing the public health - rofecoxib, Merck, and the FDA. N Engl J Med 2004, 351:1707-1709. 10.1056/NEJMp048286, 15470193.
27. Berenson A. Evidence in Vioxx suits shows intervention by Merck officials. The New York Times 2005, http://www.nytimes.com/2005/04/24/business/24drug.html
28. Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 2001, 286:954-959. 10.1001/jama.286.8.954, 11509060.
29. Curfman GD, Morrissey S, Drazen JM. Expression of concern: Bombardier et al., "comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis". N Engl J Med 2005, 353:2813-2814. 10.1056/NEJMe058314, 16339408.
30. Curfman GD, Morrissey S, Drazen JM. Expression of concern reaffirmed. N Engl J Med 2006, 354:1193. 10.1056/NEJMe068054, 16495386.
31. Fries JF. Letter to Raymond Gilmartin re: physician intimidation. 2001, Merck. Bates No MRK-ABH0002204 to MRK-ABH0002207., http://www.vioxxdocuments.com/Documents/Krumholz_Vioxx/Fries2001.pdf
32. Harris G. Pfizer says internal studies show no Celebrex risks. New York Times. Business section 2005, http://www.nytimes.com/2005/02/05/business/05drug.html
33. de Andrade M. In clear sight. BMJ 2009, 339:538-541.
34. Hrachovec JB. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001, 286:2398. 10.1001/jama.286.19.2398, 11712925.
35. Jüni P, Rutjes AW, Dieppe PA. Are selective COX 2 inhibitors superior to traditional non steroidal anti-inflammatory drugs?. BMJ 2002, 324:1287-1288. 10.1136/bmj.324.7349.1287, 1123260, 12039807.
36. Jüni P, Reichenbach S, Egger M. COX 2 inhibitors, traditional NSAIDs, and the heart. BMJ 2005, 330:1342-1343. 10.1136/bmj.330.7504.1342, 558270, 15947376.
37. Caldwell B, Aldington S, Weatherall M, Shirtcliffe P, Beasley R. Risk of cardiovascular events and celecoxib: a systematic review and meta-analysis. J R Soc Med 2006, 99:132-140. 10.1258/jrsm.99.3.132, 1383759, 16508052.
38. Braitwaite J. Corporate crime in the pharmaceutical industry 1984, London: Routledge & Kegan Paul.
39. Mundy A. Dispensing with the truth 2001, New York: St. Martin's Press.
40. Avorn J. Powerful medicines: The benefits, risks, and costs of prescription drugs 2005, New York: Vintage Books.
41. Petersen M. Our daily meds 2008, New York: Sarah Crichton Books.
42. Avorn J. Dangerous deception - hiding the evidence of adverse drug effects. N Engl J Med 2006, 355:2169-2171. 10.1056/NEJMp068246, 17124012.
43. Lurie P, Wolfe SM. Misleading data analyses in salmeterol (SMART) study. Lancet 2005, 366:1261-1262. 10.1016/S0140-6736(05)67518-6, 16214589.
44. Nissen SE, Wolski K, Topol EJ. Effect of muraglitazar on death and major adverse cardiovascular events in patients with type 2 diabetes mellitus. JAMA 2005, 294:2581-2586. 10.1001/jama.294.20.joc50147, 16239637.
45. Brophy JM. Selling safety - lessons from muraglitazar. JAMA 2005, 294:2633-2635. 10.1001/jama.294.20.jed50074, 16239638.
46. DeAngelis CD, Fontanarosa PB. Ensuring integrity in industry-sponsored research. JAMA 2010, 303:1196-1198. 10.1001/jama.2010.337, 20332409.
47. Harris G. Diabetes drug maker hid test data. New York Times 2010, http://www.nytimes.com/2010/07/13/health/policy/13avandia.html
48. Rosiglitazone CD. What went wrong?. BMJ 2010, 341:530-534.
49. Bass A. Side effects - a prosecutor, a whistleblower, and a bestselling antidepressant on trial 2008, Chapel Hill: Algonquin Books.
50. Dyer O. GlaxoSmithKline to set up comprehensive online clinical trials register. BMJ 2004, 329:590.
51. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007, 356:2457-2471. 10.1056/NEJMoa072761, 17517853.
52. Nissen SE. Setting the RECORD straight. JAMA 2010, 303:1194-1195. 10.1001/jama.2010.333, 20332408.
53. Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ. Rosiglitazone evaluated for cardiovascular outcomes - an interim analysis. N Engl J Med 2007, 357:28-38. 10.1056/NEJMoa073394, 17551159.
54. Home PD, Pocock SJ, Beck-Nielsen H, Curtis PS, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet 2009, 373:2125-2135. 10.1016/S0140-6736(09)60953-3, 19501900.
55. Psaty BM, Prentice RL. Minimizing bias in randomized trials: the importance of blinding. JAMA 2010, 304:793-794. 10.1001/jama.2010.1161, 20716744.
56. Graham D, Gelperin K. More on advisory committee decision. BMJ 2010, 341:519.
57. Cohen D. Complications: tracking down the data on oseltamivir. BMJ 2009, 339:b5387. 10.1136/bmj.b5387, 19995818.
58. Jefferson T, Doshi P, Heneghan C. Ensuring safe and effective drugs: Who can do what it takes?. BMJ 2011, 342:c7258. 10.1136/bmj.c7258, 21224325.
59. Friislund M. 10 år med Wikipedia. Berlingske Tidende 2011, sektion:1-2.
60. Walport M, Brest P. Sharing research data to improve public health. Lancet 2011, 377:537-539. 10.1016/S0140-6736(10)62234-9, 21216456.
61. Momen H. Equitable access to scientific and technical information for health. Bull World Health Organ 2003, 81:;700. 2572387, 14997253.
62. Ghersi D, Pang T. From Mexico to Mali: four years in the history of clinical trial registration. J Evidence-Based Med 2009, 2:1-7.
63. xxx X. The Bamako call to action on research for health: strengthening research for health, development, and equity. From the global ministerial forum on research for health, Bamako, Mali 2008, http://www.who.int/rpc/news/BAMAKOCALLTOACTIONFinalNov24.pdf
64. Development of the joint statement of purpose. The Wellcome Trust 2010, http://www.wellcome.ac.uk/About-us/Policy/Spotlight-issues/Data-sharing/Public-health-and-epidemiology/WTDV030691.htm
65. WHO's role and responsibilities in health research. 63rd World Health Assembly 2010, http://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_22-en.pdf
66. Science, Technology and Innovation for the 21st Century. Meeting of the OECD Committee for Scientific and Technological Policy at Ministerial Level, 29-30 January 2004 - Final Communique 2004,
67. Arzberger P, Schroeder P, Beaulieu A, Bowker G, Casey K, Laaksonen L, Moorman D, Uhlir P, Wouters P. Promoting access to public research data for scientific, economic, and social development. Data Science Journal 2004, 3:135-152.
68. Commission of the European Communities. Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee. On scientific information in the digital age. Access, dissemination and preservation. 2007. , http://ec.europa.eu/research/science-society/document_library/pdf_06/communication-022007_en.pdf
69. EudraCT Supporting Documentation. , https://eudract.ema.europa.eu/document.html
70. Communication from the Commission - Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (EC) No 1901/2006.
71. UK MRC policy on data sharing and preservation. 2011, http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/Datasharinginitiative/Policy/index.htm
72. The Wellcome Trust. Policy on data management and sharing. , http://www.wellcome.ac.uk/About-us/Policy/Policy-and-position-statements/WTX035043.htm
73. The Food and Drug Administration (FDA) Amendment Act of 2007. Public Law 110-85--Sept 27, 2007
74. Wieseler B, McGauran N, Kaiser T. Finding studies on reboxetine: a tale of hide and seek. BMJ 2010, 341:c4942. 10.1136/bmj.c4942, 20940211.
75. U.S Department of Health and Human Services. National Institutes of Health Public Access. , http://publicaccess.nih.gov/
76. National Institutes of Health. NIH Data Sharing Policy. , http://grants.nih.gov/grants/policy/data_sharing/
77. National Institutes of Health. NIH Data Sharing Policy. , http://grants.nih.gov/grants/policy/data_sharing/data_sharing_brochure.pdf
78. US National Science Foundation. Directorate for Social, Behavioral & Economic Sciences (SBE). , http://www.nsf.gov/sbe/ses/common/archive.jsp
79. US CDC/ATSDR policy on releasing and sharing data.
80. Sharing research data to improve public health: full joint statement by funders of health research. The Wellcome Trust 2010.
81. Science Magazine. General Information for Authors. , http://www.sciencemag.org/site/feature/contribinfo/prep/gen_info.xhtml
82. Nature Journals. Availability of data and materials. , http://www.nature.com/authors/editorial_policies/availability.html
83. Information for Authors. The Lancet October 2009. , http://download.thelancet.com/flatcontentassets/authors/lancet-information-for-authors.pdf
84. Groves T. Managing UK research data for future use. BMJ 2009, 338:b1252. 10.1136/bmj.b1252, 19321550.
85. Cowling BJ, Chan KH, Fang VJ, Cheng CK, Fung RO, Wai W, Sin J, Seto WH, Yung R, Chu DW, Chiu BC, Lee PW, Chiu MC, Lee HC, Uyeki TM, Houck PM, Peiris JS, Leung GM. Facemasks and hand hygiene to prevent influenza transmission in households: a cluster randomized trial. Ann Intern Med 2009, 151:437-446.
86. PLoS Medicine Editorial and Publishing Policies. Sharing of Materials, Methods and Data. , http://www.plosmedicine.org/static/policies.action
87. The Cochrane Collaboration Supports Prospective Registration of Clinical Trials. 26 July 2004.
88. Koehlmoos TP, Smith R. Big publishers cut access to journals in poor countries. Lancet 2011, 377:273-276. 10.1016/S0140-6736(11)60067-6, 21322840.
89. Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents. Official Journal of the European Communities, 31.5.2001:L 145/43-8.
90. Gøtzsche PC, Jørgensen AW. Opening up data at the European Medicines Agency. BMJ 2011, 342:d2686. 10.1136/bmj.d2686, 21558364.
91. Lenzer J. Drug secrets: what the FDA isn't telling. Slate 2005; Sept 27. , http://www.slate.com/id/2126918/
92. Abramson J. Overdo$ed America: The broken promise of American medicine 2004, New York: Harper Collins.
93. Willman D. How a new policy led to seven deadly drugs. Los Angeles Times 2000, http://www.drugawareness.org/Archives/Miscellaneous/122002Howanew.html
94. United States General Accounting Office. Food and Drug Administration: effect of user fees on drug approval times, withdrawals, and other agency activities. 2002, http://www.gao.gov/new.items/d02958.pdf
95. Carpenter D, Zucker EJ, Avorn J. Drug-review deadlines and safety problems. N Engl J Med 2008, 358:1354-1361. 10.1056/NEJMsa0706341, 18367738.
96. Carpenter D. Drug-review deadlines and safety problems (authors' reply). N Engl J Med 2008, 359:96-98.
97. Harris G, Halbfinger DM. F.D.A. reveals it fell to a push by lawmakers. New York Times 2009, http://www.nytimes.com/2009/09/25/health/policy/25knee.html
98. Lenzer J. Crisis deepens at the US Food and Drug Administration. BMJ 2004, 329:1308. 534834, 15576741.
99. Multinational Monitor. Blowing the whistle on the FDA: an interview with David Graham. , http://multinationalmonitor.org/mm2004/122004/interview-graham.html
100. Graham DJ, Campen D, Hui R, Spence M, Cheetham C, Levy G, Shoor S, Ray WA. Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet 2005, 365:475-481.
101. Union of Concerned Scientists. FDA scientists pressured to exclude, alter findings; scientists fear retaliation for voicing safety concerns. 2006, http://journals.lww.com/oncology-times/Fulltext/2006/08250/Survey_of_FDA_Scientists_Shows_They_Feel_Pressure.8.aspx
102. George J. Annas. Globalized clinical trials and informed consent. N Engl J Med 2009, 360:2050-2053. 10.1056/NEJMp0901474, 19439740.
103. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. 2008, http://www.wma.net/en/30publications/10policies/b3/index.html
104. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet 2009, 374:86-89. 10.1016/S0140-6736(09)60329-9, 19525005.
105. Wendler D, Krohmal B, Emanuel EJ, Grady C, ESPRIT G. Why patients continue to participate in clinical research. Arch Intern Med 2008, 168:1294-1299. 10.1001/archinte.168.12.1294, 18574086.
106. Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, Chan A-W. Constraints on publication rights in industry-initiated clinical trials. JAMA 2006, 295:1645-1646. 10.1001/jama.295.14.1645, 16609085.
107. Grill M. Kranke Geschäfte: wie die Pharmaindustrie uns manipuliert 2007, Hamburg: Rowohlt Verlag.
108. Garattini S. Confidentiality. Lancet 2003, 362:1078-1079. 10.1016/S0140-6736(03)14424-8, 14522545.
109. Eyding D, Lelgemann M, Grouven U, Härter M, Kromp M, Kaiser T, Kerekes MF, Gerken M, Wieseler B. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ 2010, 341:c4737. 10.1136/bmj.c4737, 2954275, 20940209.
110. Angell M. The truth about drug companies: How they deceive us and what to do about it 2004, New York: Random House.
111. Goozner M. The $800 million pill: the truth behind the cost of new drugs 2004, Berkeley: University of California Press.
112. Garattini S, Bertele V. Efficacy, safety, and cost of new anticancer drugs. BMJ 2002, 325:269-271. 10.1136/bmj.325.7358.269, 1123779, 12153927.
113. House of Commons Health Committee. The influence of the pharmaceutical industry. Fourth Report of Session 2004, http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf
114. Suntharalingam G, Perry MR, Ward S, Brett SJ, Castello-Cortes A, Brunner MD, Panoskaltsis N. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 2006, 355:1018-1028. 10.1056/NEJMoa063842, 16908486.
115. Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, Godlee F, Haug C, Hébert PC, Kotzin S, Marusic A, Sahni P, Schroeder TV, Sox HC, Van der Weyden MB, Verheugt FW. Clinical trial registration. Looking back and moving ahead. BMJ 2007, 334:1177-1178. 10.1136/bmj.39233.510810.80, 1889969, 17548363.
116. Savage CJ, Vickers AJ. Empirical study of data sharing by authors publishing in PLoS journals. PLoS ONE 2009, 4:e7078. 10.1371/journal.pone.0007078, 2739314, 19763261.
117. Dwan K, Altman DG, Cresswell L, Blundell M, Gamble CL, Williamson PR. Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database Syst Rev 2011, (1). Art. No.: MR000031.
118. Gøtzsche PC. Rational Diagnosis and Treatment. Evidence-Based Clinical Decision-Making, 4th edition 2007, Chichester: Wiley.
119. Collier J. Big pharma and the UK government. . Lancet 2006, 367:97-98. 10.1016/S0140-6736(06)67943-9, 16413862.
120. HTA clinical evaluation and trials: an open call. National Institute for Health Research. , http://www.hta.ac.uk/funding/clinicaltrials/CETSpecificationDocument_Jan11.pdf
121. Danish Research Ethics Committee System. Recommendation No. 20: controlled clinical trials - the influence of existing and newly acquired scientific results on the research ethical evaluation. Copenhagen: Danish Research Ethics Committee System; 1997.
122. Goldbeck-Wood S. Denmark takes a lead on research ethics. BMJ 1998, 316:1185.
123. Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. BMJ 1996, 313:1390-1393. 10.1136/bmj.313.7069.1390, 2352884, 8956711.
124. Baum ML, Anish DS, Chalmers TC, Sacks HS, Smith H, Fagerstrom RM. A survey of clinical trials of antibiotic prophylaxis in colon surgery: evidence against further use of no-treatment controls. N Engl J Med 1981, 305:795-799. 10.1056/NEJM198110013051404, 7266633.
125. Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC. A comparison of results of meta-analyses of randomized control trials and recommendations of clinical experts. Treatments for myocardial infarction. . JAMA 1992, 268:240-248. 10.1001/jama.268.2.240, 1535110.
126. Fergusson D, Glass KC, Hutton B, Shapiro S. Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding. ? Clin Trials 2005, 2:218-229. discussion 229-232, 10.1191/1740774505cn085oa, 16279145.
127. Robinson KA, Goodman SN. A systematic examination of the citation of prior research in reports of randomized, controlled trials. Ann Intern Med 2011, 154:50-55.
128. Clinard MB, Brissette J, Petrashek D, Harries E. Illegal corporate behaviour 1979, Washington, D.C.: Law Enforcement Assistance Administration.
129. Transparency International. Global Corruption Report 2006, http://www.transparency.org/publications/gcr
130. Kassirer JP. On the take: how medicine's complicity with big business can endanger your health 2005, Oxford: Oxford University Press.
131. Nina Vinther Andersen Vores piller 2009, København: Tiderne Skifter, Nina Vinther Andersen.
132. Brody H. Hooked. Ethics, the medical profession, and the pharmaceutical industry 2007, Lanham: Rowman & Littlefield.
133. Marsa L. Prescription for profits. How the pharmaceutical industry bankrolled the unholy marriage between science and business 1997, New York: Scribner.
134. Abraham J. Science, Politics, and the Pharmaceutical Industry 1995, London: UCL Press.
135. Brownlee S. Overtreated. Why too much medicine is making us sicker and poorer 2008, New York, Bloomsbury.
136. Moynihan & Cassels Selling sickness. How the world's biggest pharmaceutical companies are turning us all into patients 2005, New York: Nation Books, Moynihan & Cassels.
137. Rost P. The whistleblower, confessions of a healthcare hitman 2006, New York: Soft Skull Press.
138. Pharmaceutical industry is biggest defrauder of the Federal Government under the False Claims Act, New Public Citizen Study Finds. 2010, http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3239
139. Tanne JH. Pfizer pays record fine for off-label promotion of four drugs. BMJ 2009, 339:b3657.
140. The Cochrane Collaboration supports free access to all data from all clinical trials. , http://www.cochrane.org/about-us/our-policies/support-free-access-to-all-data-from-all-clinical-trials
141. Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. BMJ 2010, 340:c181. 10.1136/bmj.c181, 2813427, 20110312.