Disclosure of Investigators' Recruitment Performance in Multicenter Clinical Trials: A Further Step for Research Transparency
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Vyšlo v časopise:
Disclosure of Investigators' Recruitment Performance in Multicenter Clinical Trials: A Further Step for Research Transparency. PLoS Med 8(12): e32767. doi:10.1371/journal.pmed.1001149
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Policy Forum
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https://doi.org/10.1371/journal.pmed.1001149
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Zdroje
1. De AngelisCDrazenJMFrizelleFAHaugCHoeyJ 2004 Clinical trial registration: a statement from the international Committee of Medical Journal Editors. Ann Intern Med 141 477 478
2. SimIChanAWGulmezogluAMEvansTPangT 2006 Clinical trial registration: transparency is the watchword. Lancet 367 1631 1633
3. World Medical Association 2008 Declaration of Helsinki. Available: http://www.wma.net/en/10home/index.html. Accessed 17 July 2011
4. Food and Drug Administration Amendments Act of 2007. Available: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110. Accessed 17 July 2011
5. World Health Organization 2011 International Clinical Trials Registry Platform (ICTRP). Available: http://www.who.int/ictrp/en/. Accessed 13 October 2011
6. National Institutes of Health 2011 ClinicalTrials.gov. Available: http://clinicaltrials.gov/. Accessed 22 May 2011
7. McDonaldAMKnightRCCampbellMKEntwistleVAGrantAM 2006 What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials 7 9
8. ValeCStewartLTierneyJ the UK Coordinating Committee for Cancer Research. National Register of Cancer 2005 Trends in UK cancer trials: results from the UK Coordinating Committee for Cancer Research National Register of Cancer Trials. Br J Cancer 92 811 814
9. ChengSKDietrichMSDiltsM 2010 A sense of urgency: evaluating the link between clinical trial development time and the accrual performance of cancer therapy evaluation program (NCI-CTEP) sponsored studies. Clin Cancer Res 16 5557 5563
10. Dal-RéROrtegaREspadaJ 1998 Eficiencia de los investigadores en la selección de los enfermos para ensayos clínicos: a propósito de un estudio multinacional. [Efficiency of investigators in recruitment of patients for clinical trials: a propos of a multinational study] Med Clin (Barc) 110 521 523
11. MalakoffD 2008 Clinical trials and tribulations. Spiraling costs threaten gridlock. Science 322 210 213
12. PichJCarnéXArnaízJAGómezBTrillaA 2003 Role of a research ethics committee in follow-up and publication of results. Lancet 361 1015 1016
13. WisePDruryM 1996 Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners. BMJ 313 1245 1248
14. DecullierELheritierVChapuisF 2005 Fate of biomedical research protocols and publication bias in France: retrospective cohort study. BMJ 331 19 doi:10.1136/bmj.38488.385995.8F
15. International Conference on Harmonisation of technical requirements for Registration of Pharmaceuticals for Human Use 2006 ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6 (R1) June 1996. Available: http://www.ich.org/home.html. Accessed 17 July 2011
16. CaldwellPHYHamiltonSTanACraigJC 2010 Strategies for increasing recruitment to randomized controlled trials: systematic review. PLoS Med 7 e1000368 doi:10.1371/journal.pmed.1000368
17. TreweekSMitchellEPitkethlyMCookJKjeldstrømM 2010 Strategies to improve recruitment to randomised controlled trials. Cochrane Database Syst Rev MR000013
18. MoherDDulbergCSWellsGA 1994 Statistical power, sample size and their reporting in randomized controlled trials. JAMA 272 122 124
19. ChanAWHróbjartssonAJørgensenKJGøtzschePCAltmanDG 2008 Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols. BMJ 337 a2299
20. GluudC 2006 The culture of designing hepato-biliary reandomised trials. J Hepatol 44 607 615
21. BourgeoisFTMurthySMandlKD 2010 Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med 153 158 166
22. ZarinDATseTWilliamsRCaliffRMIdeNC 2011 The ClinicalTrials.gov results database—update and key issues. N Engl J Med 364 852 860
23. BlairJEAZannadFKonstamMACookTTraverB 2008 Continental differences in clinical characteristics, management, and outcomes in patients hospitalized with worsening heart failure. JACC 52 1640 1648
24. AliMAtulaSBathPMGrottaJHackeW 2009 Stroke outcome in clinical trials patients deriving from different countries. Stroke 40 35 40
25. WallentinLBeckerRCBudajACannonCPEmanuelssonH 2009 Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 361 1045 1057
26. KalbPEKoehlerKG 2002 Legal issues in scientific research. JAMA 287 85 91
27. SteenRG 2011 Retractions in the scientific literature: is the incidence of research fraud increasing? J Med Ethics 37 249 253
28. European Medicines Agency 2010 Clinical trials submitted in marketing authorization applications to the EMA. Overview of patient recruitment and geographical location of investigator sites. EMA/INS/GCP/154352/2010. 5 November 2010. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/12/WC500016819.pdf. Accessed 17 July 2011
29. BoultonGRawlinsMVallancePWalportM 2011 Science as public enterprise: the case for open data. Lancet 377 1633 1635
30. ChanAW 2011 Access to clinical trial data. BMJ 342 117
31. WalportMBrestP 2011 Sharing research data to improve public health. Lancet 377 537 539
32. HopewellSAltmanDGMoherDSchulzKF 2008 Endorsement of the CONSORT Statement by high impact factor medical journals: a survey of editors and journal ‘instructions to authors’. Trials 9 20
33. TreweekSLoudonK 2011 Incomplete reporting of recruitment information in breast cancer trials published between 2003 and 2008. J Clin Epidemiol 64 1216 1222
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PLOS Medicine
2011 Číslo 12
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