Чтение онлайн

7. Suntharalingam G, Perry MR, Ward S, Brett SJ, Castello-Cortes A, Brunner MD, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N. Engl. J. Med. 2006 Sep 7;355(10):1018-28.

8. Expert Group on Phase One Clinical Trials: Final report [Internet]. 2006 [cited 2012 Apr 5]. Available from:gov.uk/en/Publicationsandstatistics/Publications PublicationsPolicyAndGuidanceDH_063117

9. Decullier E, Chan A-W, Chapuis F. Inadequate Dissemination of Phase I Trials: A Retrospective Cohort Study. PLoS Med. 2009 Feb 17;6(2):e1000034.

10. 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. International journal of cardiology. 1993;40(2):161-6. Iain Chalmers was the first to raise TGN1412 and anti-arrhythmics as examples of the harm done when individual early trials are left unpublished. They are the best illustrations of this problem, but you should not imagine that they are unusual: the quantitative data shows that they are just two among many, many similar cases.

11. Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC. A comparison of results of metaanalyses of randomized control trials and recommendations of clinical experts. Treatments for myocardial infarction. JAMA. 1992 Jul 8;268(2):240-8.

12. 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 Jan 17;358(3):252-60.

13. Here is the classic early paper arguing this point: Chalmers Iain. Underreporting Research Is Scientific Misconduct. JAMA. 1990 Mar 9;263(10):1405–1408.

14. Sterling T. Publication decisions and their possible effects on inferences drawn from tests of significance or vice versa. Am Stat Assoc J 1959;54:30-4.

15. Sterling TD, Rosenbaum WL, Weinkam JJ. Publication decisions revisited the effect of the outcome of statistical tests on the decision to publish and vice-versa. Am Stat 1995;49: 108-12.

16. Bacon F (1645). Franc Baconis de Verulamio/Summi Angliae Cancellarii/Novum organum scientiarum. [Francis Bacon of St. Albans Lord Chancellor of England. A ‘New Instrument’ for the sciences] Lugd. Bat: apud Adrianum Wiingaerde, et Franciscum Moiardum. Aphorism XLVI (p.45–46).

17. Fowler T (1786). Medical reports of the effects of arsenic in the cure of agues, remitting feveres and periodic headachs. London: J Johnson, pp 105–107.

18. Hemminki E. Study of information submitted by drug companies to licensing authorities. Br Med J. 1980 Mar 22;280(6217): 833-6.

19. Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med 2008;5(9):e191.

20. 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.

21. Rising K, Bacchetti P, Bero L. Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation. PLoS Med. 2008 Nov 25;5(11):e217.

22. Scherer RW, Langenberg P, von Elm E. Full publication of results initially presented in abstracts. Cochrane Database Syst Rev 2007; 2: MR000005.

23. Song F, Parekh S, Hooper L, Loke YK, Ryder J, Sutton AJ, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess. 2010 Feb;14(8):iii, ix-xi, 1-193.

24. Dickersin K. How important is publication bias? A synthesis of available data. Aids Educ Prev 1997;9(1 SA):15–21.

25. Ioannidis J. Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials. JAMA 1998;279:281-6.

26. Bardy AH. Bias in reporting clinical trials. Brit J Clin Pharmaco 1998;46:147-50.

27. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS ONE 2008;3(8):e3081.

28. Decullier E, Lheritier V, Chapuis F. Fate of biomedical research protocols and publication bias in France: retrospective cohort study. BMJ 2005;331:19. Decullier E, Chapuis F. Impact of funding on biomedical research: a retrospective cohort study. BMC Public Health 2006;6:165.

29. Cronin E, Sheldon T. Factors influencing the publication of health research. Int J Technol Assess 2004;20:351-5.

30. Song F, Parekh S, Hooper L, Loke YK, Ryder J, Sutton AJ, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess. 2010 Feb;14(8):iii, ix-xi, 1-193.

31. This was first pointed out to me by Jamie Heywood from PatientsLikeMe, who spent huge resources trying and failing to replicate research findings in another area of medicine. The last time I saw him we talked about writing up his idea that the likelihood of a claim being true is proportional tothe cost of making it, and inversely proportional to the cost of refuting it. We’ve not done so, and until then, a description of our conversation is the only reference for this neat idea.

32. Begley CG, Ellis LM. Drug development: Raise standards for preclinical cancer research. Nature. 2012 Mar 28;483(7391): 531-3.

33. Harrabin R et al (2003). Health In The News, The King’s Fund, London, UK.

34. Forsyth, Alasdair J. M. 2001. Distorted? a quantitative exploration of drug fatality reports in the popular press. International Journal of Drug Policy 12, no. 5–6 (November 1): 435–453.

35. Dickersin K, Min YI, Meinert CL: Factors influencing publication of research results: follow-up of applications submitted to two institutional review boards. JAMA 1992, 267:374–378.

36. Olson CM, Rennie D, Cook D, Dickersin K, Flanagin A, Hogan JW, Zhu Q, Reiling J, Pace B: Publication bias in editorial decision making. JAMA 2002, 287:2825–2828.

37. Lee KP, Boyd EA, Holroyd-Leduc JM, Bacchetti P, Bero LA. Predictors of publication: characteristics of submitted manuscripts associated with acceptance at major biomedical journals. Med J Aust 2006;184:621-6. Lynch JR, Cunningham MRA, Warme WJ, Schaad DC, Wolf FM, Leopold SS. Commercially funded and United States-based research is more likely to be published; good-quality studies with negative outcomes are not. J Bone Joint Surg Am 2007;89:1010-8. Okike K, Kocher MS, Mehlman CT, Heckman JD, Bhandari M. Publication bias in orthopaedic research: an analysis of scientific factors associated with publication in the Journal of Bone and Joint Surgery. J Bone Joint Surg Am 2008;90:595–601.