Глава 4. Обман в исследованиях

1. Anesthesiology News Fraud Case Rocks Anesthesiology Community [Internet]. [cited 2012 Feb 12]. Available from: http://www.anesthesiologynews.com/ViewArticle.aspx?d=Policy per cent2B per cent26amp per cent3B per cent2BManagement&d_id=3&i=March per cent2B2009&i_id=494&a_id=12634&ses=ogst

2. This story is well covered in Wells F. Fraud and Misconduct in Biomedical Research. Chapter 5, Fourth ed. RSM Books; 2008. I highly recommend this book if you want to get started reading about fraud detection and management. Beware that it’s an academic book, and therefore appallingly expensive.

3. Rothwell PM. External validity of randomised controlled trials: ‘To whom do the results of this trial apply?’ The Lancet. 2005 Jan 1; 365(9453):82–93.

4. Pratt, C.M. & Moye, L.A., 1995. The Cardiac Arrhythmia Suppression Trial: Casting Suppression in a Different Light. Circulation, 91(1), pp.245–247.

5. Travers, J. et al., 2007. External validity of randomised controlled trials in asthma: to whom do the results of the trials apply? Thorax, 62(3), pp.219–223.

6. Zimmerman, M., Chelminski, I. & Posternak, M.A., 2004. Exclusion criteria used in antidepressant efﬁcacy trials: consistency across studies and representativeness of samples included. The Journal of Nervous and Mental Disease, 192(2), pp.87–94.

7. Keitner, G.I., Posternak, M.A. & Ryan, C.E., 2003. How many subjects with major depressive disorder meet eligibility requirements of an antidepressant efﬁcacy trial? The Journal of Clinical Psychiatry, 64(9), pp.1091-3.

8. Jarvinen TLN, Sievanen H, Kannus P, Jokihaara J, Khan KM. The true cost of pharmacological disease prevention. BMJ. 2011 Apr 19;342(apr19 1):d2175-d2175.

9. Van Staa T-P, Leufkens HG, Zhang B, Smeeth L. A Comparison of Cost Effectiveness Using Data from Randomized Trials or Actual Clinical Practice: Selective Cox-2 Inhibitors as an Example. PLoS Med. 2009 Dec 8;6(12):e1000194.

10. Safer DJ. Design and reporting modiﬁcations in industrysponsored comparative psychopharmacology trials. J. Nerv. Ment. Dis. 2002 Sep;190(9):583-92.

11. Califf RM, DeMets DL. Principles From Clinical Trials Relevant to Clinical Practice: Part I. Circulation. 2002 Aug 20;106(8):1015-21.

12. Mueller PS, Montori VM, Bassler D, Koenig BA, Guyatt GH. Ethical Issues in Stopping Randomized Trials Early Because of Apparent Beneﬁt. Annals of Internal Medicine. 2007 Jun 19;146(12):878–881.

13. Bassler D, Briel M, Montori VM, Lane M, Glasziou P, Zhou Q, et al. Stopping Randomized Trials Early for Beneﬁt and Estimation of Treatment Effects: Systematic Review and Metaregression Analysis. JAMA. 2010 Mar 24;303(12):1180-7.

14. Montori VM, Devereaux PJ, Adhikari NKJ, Burns KEA, Eggert CH, Briel M, et al. Randomized Trials Stopped Early for Beneﬁt: A Systematic Review. JAMA. 2005 Nov 2;294(17):2203-9.

15. Trotta F, Apolone G, Garattini S, Tafuri G. Stopping a trial early in oncology: for patients or for industry? Annals of Oncology [Internet]. 2008 Jan 1 [cited 2012 Feb 14]; Available from: http:// annonc.oxfordjournals.org/content/early/2008/04/09/ann onc. mdn042.full

16. Lurie P, Wolfe SM. Misleading data analyses in salmeterol (SMART) study. The Lancet. 2005 Oct;366(9493):1261-2.

17. Rickard KA. Misleading data analyses in salmeterol (SMART) study GlaxoSmithKline’s reply. The Lancet. 2005 Oct;366(9493): 1262.

18. Garcialopez F, Dealvaro F. INSIGHT and NORDIL. The Lancet. 2000 Dec 2;356(9245):1926–1926.

19. Safer DJ. Design and reporting modiﬁcations in industrysponsored comparative psychopharmacology trials. J. Nerv. Ment. Dis. 2002 Sep;190(9):583-92.

20. Gilbody S, Wahlbeck K, Adams C. Randomized controlled trials in schizophrenia: a critical perspective on the literature. Acta Psychiatr Scand. 2002;105:243–251.

21. Montori VM, Jaeschke R, Schunemann HJ, Bhandari M, Brozek JL, Devereaux PJ, et al. Users’ guide to detecting misleading claims in clinical research reports. BMJ. 2004 Nov 6;329(7474):1093-6.

22. Shaughnessy AF, Slawson DC. What happened to the valid POEMs? A survey of review articles on the treatment of type 2 diabetes. BMJ. 2003 Aug 2;327(7409):266.

23. 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;326:1171-3.

24. Vedula, S Swaroop, Lisa Bero, Roberta W Scherer, and Kay Dickersin. ‘Outcome reporting in industry-sponsored trials of gabapentin for off-label use.’ The New England Journal of Medicine 361, no. 20 (November 12, 2009): 1963–1971.

25. Chan A-W, Hrobjartsson A, Haahr MT, G0tzsche PC, Altman DG: Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004, 291:2457–2465.

26. Jon N. Jureidini, Leemon B. McHenry, Peter R. Mansﬁeld. Clinical trials and drug promotion: Selective reporting of study 329. International Journal of Risk & Safety in Medicine 20 (2008) 7381 73 DOI 10.3233/JRS-2008-0426.

27. K L Lee et al., ‘Clinical judgment and statistics. Lessons from a simulated randomized trial in coronary artery disease,’ Circulation 61, no. 3 (March 1980): 508-15.

28. On subgroup analysis, I recommend this excellent 2005 review article by Peter Rothwell: Rothwell PM. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. The Lancet. 2005;365(9454):176-86. Currently available free online at http://apps.who.int/rhl/Lancet_3659454.pdf

29. EuropeanCarotidSurgeryTrialists’CollaborativeGroup. Randomised trial of endarterectomy for recently symptomatic carotid stenosis: ﬁnal results of the MRC European Carotid Surgery Trial (ECST). Lancet 1998; 351: 1379-87.

30. The Canadian Cooperative Study Group. A randomised trial of aspirin and sulﬁnpyrazone in threatened stroke. N Engl J Med 1978; 299: 53–59.

31. Ioannidis JPA, Karassa FB. The need to consider the wider agenda in systematic reviews and meta-analyses: breadth, timing, and depth of the evidence. BMJ. 2010 Sep;341(sep13 1):c4875c4875.

32. Hill KP, Ross JS, Egilman DS, Krumholz HM. The ADVANTAGE Seeding Trial: A Review of Internal Documents. Annals of Internal Medicine. 2008;149(4):251-8.

33. Sox HC, Rennie D. Seeding Trials: Just Say „No» Annals of Internal Medicine. 2008;149(4):279-80.

34. Krumholz SD, Egilman DS, Ross JS. Study of Neurontin: Titrate to Effect, Proﬁle of Safety (STEPS) Trial: A Narrative Account of a Gabapentin Seeding Trial. Arch Intern Med. 2011 Jun 27;171(12):1100—7.

35. I recommend this book as an introduction to ‘shared decision making’ (I helped on one chapter): Gigerenzer G, Muir G. Better Doctors, Better Patients, Better Decisions: Envisioning Health Care 2020. 1st ed. MIT Press; 2011.

36. Malenka DJ, Baron JA, Johansen S, Wahrenberger JW, Ross JM. The framing effect of relative and absolute risk. J Gen Intern Med. 1993 Oct;8(10):543-8.

37. Bucher HC, Weinbacher M, Gyr K. Inﬂuence of method of reporting study results on decision of physicians to prescribe drugs to lower cholesterol concentration. BMJ. 1994 Sep 24;309(6957):761-4.

38. Fahey T, Grifﬁths S, Peters TJ. Evidence based purchasing: understanding results of clinical trials and systematic reviews. BMJ. 1995 Oct 21;311(7012):1056-9.

39. Express.co.uk New wonder heart pill that may save millions [Internet]. [cited 2012 Feb 12]. Available from: http://www.express. co.uk/posts/view/70343.

40. Drug could save thousands from heart attacks Science The Guardian [Internet]. [cited 2012 Feb 12]. Available from: http://www.guardian.co.uk/science/2008/nov/10/drugsmedical-research

41. Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsigniﬁcant Results for Primary Outcomes. JAMA. 2010 May 26;303(20):2058-64.

42. Alasbali, T. et al., 2009. Discrepancy between results and abstract conclusions in industry vs nonindustry-funded studies comparing topical prostaglandins. American Journal of Ophthalmology, 147(1), pp.33–38.e2.

43. Jorgensen AW, Hilden J, Gotzsche PC. Cochrane reviews compared with industry supported meta-analyses and other metaanalyses of the same drugs: systematic review. BMJ. 2006 Oct 14;333(7572):782.

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