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Protecting Clinical Trial Participants and Protecting Data Integrity: Are We Meeting the Challenges?


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Vyšlo v časopise: Protecting Clinical Trial Participants and Protecting Data Integrity: Are We Meeting the Challenges?. PLoS Med 9(6): e32767. doi:10.1371/journal.pmed.1001234
Kategorie: Essay
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1001234

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Zdroje

1. Heart Special Project Committee 1988 Organization, review and administration of cooperative studies: a report from the Heart Special Projects Committee to the National Advisory Heart Council, May 1967. Control Clin Trials 9 137 148

2. PocockSJ 1977 Group sequential methods in the design and analysis of clinical trials. Biometrika 64 191 199

3. O'BrienPCFlemingTR 1979 A multiple testing procedure for clinical trials. Biometrics 35 549 556

4. LanKKGDeMetsDL 1983 Discrete sequential boundaries for clinical trials. Biometrika 70 659 663

5. WhiteheadJ 1983 The design and analysis of sequential clinical trials New York Halsted Press

6. EllenbergSSGellerNSimonRYusufS 1993 Proceedings of “Practical Issues in Data Monitoring of Clinical Trials.” Stat Med 12 415 616

7. EllenbergSSFlemingTRDeMetsDL 2002 Data monitoring committees in clinical trials: a practical perspective Chichester John Wiley & Sons, Ltd

8. DeMetsDLFurbergCDFriedmanLM 2006 Data monitoring in clinical trials a case studies approach New York Springer

9. HersonJ 2009 Data and safety monitoring committees in clinical trials Boca Raton Chapman & Hall

10. National Institutes of Health 1998 NIH policy for data and safety monitoring. Available: http://grants.nih.gov/grants/guide/notice-files/not98-084.html. Accessed 15 October 2011

11. Food and Drug Administration 2006 Guidance for clinical trial sponsors: establishment and operation of clinical trial data monitoring committees. Available: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf. Accessed 15 October 2011

12. European Medicines Agency Committee for Medicinal Products for Human Use 2005 Guideline on data monitoring committees. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003635.pdf. Accessed 15 October 2011

13. World Health Organization 2005 Operational guidelines for the establishment and functioning of data and safety monitoring boards. Available: http://whqlibdoc.who.int/hq/2005/TDR_GEN_Guidelines_05.1_eng.pdf. Accessed 15 October 2011

14. GrantAMSydesMMcLeerSClemensFAltmanDG 2005 Issues in data monitoring and interim analysis of trials (the DAMOCLES study). Health Technology Assess 9 1 238

15. SydesMRSpiegelhalterDJAltmanDGBabikerABParmarMK 2004 Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials. Clin Trials 1 60 79

16. SydesMRAltmanDGBabikerABParmarAKSpiegelhalterDJ 2004 Reported use of data monitoring committees in the main published reports of randomized controlled trials. Clin Trials 1 48 59

17. PresleyH. Vioxx and the Merck team effort. The Kenan Institute for Ethics at Duke University. Available: http://www.duke.edu/web/kenanethics/CaseStudies/Vioxx.pdf. Accessed 15 October 2011

18. DrazenJMWoodAJJ 2010 Don't mess with the DSMB. N Eng J Med 363 477 478

19. MenikoffJ 2010 The paradoxical problem with multiple-IRB review. N Eng J Med 363 1591 1593

20. KlitzmanR 2011 How local IRBs view central IRBs in the US. BMC Medical Ethics 12 13 http://www.biomedcentral.com/1472-6939/12/13. Accessed 20 April 2012

21. WittesJBarrett-ConnerEBraunwaldEChesneyMCohenHJ 2007 Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board. Clin Trials 4 218 234

22. MonderoTH 2009 Data safety monitoring boards: a word from a sponsor (NHLBI). Transfusion 49 1537 1539

23. DixonDOWeissSCahillKFoxLLoveJ 2011 Data and safety monitoring policy for National Institute of Allergy and Infectious Diseases clinical trials. Clin Trials 8 727 735

24. National Heart, Lung, and Blood Institute October 2011 NHLBI policy for data and safety monitoring of extramural clinical studies. Available: http://www.nhlbi.nih.gov/funding/policies/dsmpolicy.htm. Accessed 20 April 2012

25. DeMetsDLFlemingTR 2004 The independent statistician for data monitoring committees. Stat Med 23 1513 1517

26. SiegelJPO'NeillRTTempleRCampbellGFoulkesMA 2004 Independence of the statistician who analyses unblinded data. Stat Med 23 1527 1529

27. PocockSJ 2004 A major trial needs three statisticians: why, how and who? Stat Med 23 1535 1539

28. EllenbergSSGeorgeSL 2004 Should statisticians reporting to a data monitoring committee be independent of the trial sponsor and leadership? Stat Med 23 1503 1505

29. WittesJ 2004 Playing safe and preserving integrity: making the FDA model work. Stat Med 23 1523 1525

30. McPhersonK 1974 Statistics: the problem of examining accumulating data more than once. N Engl J Med 290 501 502

31. PocockSJ 1992 When to stop a clinical trial. BMJ 305 235 240

32. Discussion in EllenbergSGellerNSimonRYusufS Proceedings of “Practical Issues in Data Monitoring of Clinical Trials.” Stat Med 12 521 525

33. BasslerDMontoriVBrielMGlasziouPGuyattG 2008 Early stopping of randomized clinical trials for overt efficacy is problematic. J Clin Epid 61 241 246

34. BasslerDBrielMMontoriVMLaneMGlasziouP 2010 Stopping randomized trials early for benefit and estimation of treatment effects. JAMA 303 1180 1187

35. BerrySMCarlinBPConnorJ 2010 Bias and trials stopped early for benefit (letter). JAMA 304 156

36. GoodmanSBerryDWittesJ 2010 Bias and trials stopped early for benefit (letter). JAMA 304 157

37. KornELFriedlinBMooneyM 2010 Bias and trials stopped early for benefit (letter). JAMA 304 157 158

38. EllenbergSSDeMetsDLFlemingTR 2010 Bias and trials stopped early for benefit (letter). JAMA 304 158

39. WheatleyKClaytonD 2003 Be skeptical about unexpected large apparent treatment effects: the case of an MRC AML 12 randomization. Control Clin Trials 24 66 70

40. DeMetsDLFlemingTRRockholdFMassieBMerchantT 2004 Liability issues for data monitoring committee members. Clin Trials 1 525 531

41. TereskerzPM 2010 Data safety monitoring boards: legal and ethical considerations for research accountability. Account Res 17 30 50

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Interné lekárstvo

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PLOS Medicine


2012 Číslo 6
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