SPIRIT 2013聲明：定義臨床研究方案的標準條目△_《中國循證醫學雜志》

作者：

AnWen ChanJennifer M. TetzlaffDouglas G. AltmanAndreas LaupacisPeter C. Goslash , tzscheKarmela KrleaJeriAsbjoslash , rn HrbjartssonHoward MannKay DickersinJesse A. BerlinCaroline J. DorWendy R. ParulekarWilliam S.M. SummerskillTrish GrovesKenneth F. SchulzHarold C. SoxFrank W. Rockhold Drummond RennieDavid Moher

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DOI：

10.7507/1672-2531.20130256

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引用本文： . SPIRIT 2013聲明：定義臨床研究方案的標準條目△. 中國循證醫學雜志, 2013, 13(12): 1501-1507. doi: 10.7507/1672-2531.20130256 復制

1.	Rennie D. Trial registration: a great idea switches from ignored to irresistible. JAMA, 2004, 292(11): 1359-1362.
2.	DeAngelis CD, Fontanarosa PB. Strengthening the credibility of clinical research. Lancet, 2010, 375(9722): 1225.
3.	Summerskill W, Collingridge D, Frankish H. Protocols, probity, and publication. Lancet, 2009, 373(9668): 992.
4.	Jones G, Abbasi K. Trial protocols at the BMJ. BMJ, 2004, 329(9668): 1360.
5.	Groves T. Let SPIRIT take you towards much clearer trial protocols. BMJ Group Blogs. 25 September 2009. Accessed at http://blogs.bmj.com/bmj/2009/09/25/trish-groves-let-spirit-take-you-towards-much-clearer-trial-protocols/ on 1October 2012.
6.	Altman DG, Furberg CD, Grimshaw JM, et al. Lead editorial:trials-using the opportunities of electronic publishing to improve the reporting of randomised trials. Trials, 2006, 7(23): 6.
7.	Turner EH. A taxpayer-funded clinical trials registry and results database. PLoS Med, 2004, 1(3): e60.
8.	Coultas D. Ethical considerations in the interpretation and communication of clinical trial results. Proc Am Thorac Soc, 2007, 4(2): 194-198.
9.	Siegel JP. Editorial review of protocols for clinical trials. N Engl J Med, 1990, 323(19): 1355.
10.	Murray GD. Research governance must focus on research training. BMJ, 2001, 322(7300): 1461-1462.
11.	Chan AW. Access to clinical trial data. BMJ, 2011, 12(342): d80.
12.	Miller JD. Registering clinical trial results: the next step. JAMA, 2010, 303(8): 773-774.
13.	Krle?a-Jeri? K, Chan AW, Dickersin K, et al. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ, 2005, 330(7497): 956-958.
14.	Lassere M, Johnson K. The power of the protocol. Lancet, 2002, 360(9346): 1620-1622.
15.	Getz KA, Zuckerman R, Cropp AB, et al. Measuring the incidence, causes, and repercussions of protocol amendments. Drug Inf J, 2011, 45: 265-275.
16.	Public Citizen Health Research Group v. Food and Drug Administration, 964 F Supp. 413 (DDC 1997).
17.	Tetzlaff JM, Chan AW, Kitchen J, et al. Guidelines for randomized clinical trial protocol content: a systematic review. Syst Rev, 2012, 1: 43.
18.	Chan AW, Hróbjartsson A, Haahr MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA, 2004, 291(20): 2457-2465.
19.	Smyth RM, Kirkham JJ, Jacoby A, et al. Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists. BMJ, 2011, 342: c7153.
20.	Pildal J, Chan AW, Hróbjartsson A, et al. Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study. BMJ, 2005, 330 (7499): 1049.
21.	Mhaskar R, Djulbegovic B, Magazin A, et al. Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols. J Clin Epidemiol, 2012, 65(6): 602-609.
22.	Hróbjartsson A, Pildal J, Chan AW, et al. Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory. J Clin Epidemiol, 2009, 62(9): 967-973.
23.	Scharf O, Colevas AD. Adverse event reporting in publications compared with sponsor database for cancer clinical trials. J Clin Oncol, 2006, 24(24): 3933-3938.
24.	Chan AW, Hro´bjartsson A, Jørgensen KJ, et al. Discrepancies in sample size calculations and data analyses reported in randomized trials: comparison of publications with protocols. BMJ, 2008, 337: a2299.
25.	Al-Marzouki S, Roberts I, Evans S, et al. Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet, 2008, 372(9634): 201.
26.	Hernández AV, Steyerberg EW, Taylor GS, et al. Subgroup analysis and covariate adjustment in randomized clinical trials of traumatic brain injury: a systematic review. Neurosurgery, 2005, 57(6): 1244-1253.
27.	Gøtzsche PC, Hróbjartsson A, Johansen HK, et al. Constraints on publication rights in industry-initiated clinical trials. JAMA, 2006, 295(14): 1645-1646.
28.	Gøtzsche PC, Hróbjartsson A, Johansen HK, et al. Ghost authorship in industry-initiated randomised trials. PLoS Med, 2007, 4(1): e19.
29.	Lundh A, Krogsbøll LT, Gøtzsche PC. Access to data in industry-sponsored trials. Lancet, 2011, 378(9808): 1995-1996.
30.	Hopewell S, Dutton S, Yu LM, et al. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ, 2010, 340: c723.
31.	Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ, 2013, 346: e7586.
32.	Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med, 2010, 7: e1000217.
33.	Tetzlaff JM, Moher D, Chan AW. Developing a guideline for clinical trial protocol content: Delphi consensus survey. Trials, 2012, 13: 176.
34.	World Medical Association. WMA Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects. Accessed at www.wma.net/en/30publications/10policies/b3/index.html on 1 October 2012.
35.	International Conference on Harmonisation. ICH Harmonised Tripartite Guideline: General Considerations for Clinical Trials: E8. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 17 July 1997. Accessed at www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E8/Step4/E8_Guideline.pdf on 1 October 2012.
36.	International Conference on Harmonisation. ICH Harmonised Tripartite Guideline: Statistical Principles for Clinical Trials: E9. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 5 February 1998. Accessed at www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf on 1 October 2012.
37.	International Conference on Harmonisation. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice: E6. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 10 June 1996. Accessed at www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf on 1 October 2012.
38.	Grimes DA, Hubacher D, Nanda K, et al. The Good Clinical Practice guideline: a bronze standard for clinical research. Lancet, 2005, 366(9480): 172-174.
39.	Sim I, Chan AW, Gülmezoglu AM, et al. Clinical trial registration: transparency is the watchword. Lancet, 2006, 367(9523): 1631-1633.
40.	Laine C, De Angelis C, Delamothe T, et al. Clinical trial registration: looking back and moving ahead. Ann Intern Med, 2007, 147: 275-277.
41.	Food and Drug Administration Amendments Act of 2007, HR 2580, 110th Congress, 1st Sess, Title VIII, §801 (2007). Expanded Clinical Trial Registry Data Bank. Accessed at www.govtrack.us/congress/billtext.xpd?bill_h110-3580 on 1 October 2012.
42.	European Commission. Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004(2008/C 168/02). Official Journal of the European Union. 2008, 51: 3-4.
43.	Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med, 2010, 152(11): 726-732.
44.	National Research Council. A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. Washington, DC: National Academies Pr; 2010.
45.	Chan AW. Out of sight but not out of mind: how to search for unpublished clinical trial evidence. BMJ, 2012, 344: d8013.
46.	Wieseler B, Kerekes MF, Vervoelgyi V, et al. Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications. BMJ, 2012, 344: d8141.
47.	Reveiz L, Chan AW, Krle?a-Jeri? K, et al. Reporting of methodologic information on trial registries for quality assessment: a study of trial records retrieved from the WHO search portal. PLoS One, 2010, 5(8): e12484.
48.	Dwan K, Altman DG, Cresswell L, et al. Comparison of protocols and registry entries to published reports for randomized controlled trials. Cochrane Database Syst Rev. 2011: MR000031.
49.	Dwan K, Altman DG, Arnaiz JA, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One, 2008, 3(8): e3081.
50.	GlaxoSmithKline. Public disclosure of clinical research. Global Public Policy Issues. October 2011. Accessed at www.gsk.com/policies/GSK-on-disclosure-of-clinical-trial-information.pdf on 1 October 2012.
51.	Turner L, Shamseer L, Altman DG, et al. Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review. Syst Rev, 2012, 1: 60.

1. Rennie D. Trial registration: a great idea switches from ignored to irresistible. JAMA, 2004, 292(11): 1359-1362.
2. DeAngelis CD, Fontanarosa PB. Strengthening the credibility of clinical research. Lancet, 2010, 375(9722): 1225.
3. Summerskill W, Collingridge D, Frankish H. Protocols, probity, and publication. Lancet, 2009, 373(9668): 992.
4. Jones G, Abbasi K. Trial protocols at the BMJ. BMJ, 2004, 329(9668): 1360.
5. Groves T. Let SPIRIT take you towards much clearer trial protocols. BMJ Group Blogs. 25 September 2009. Accessed at http://blogs.bmj.com/bmj/2009/09/25/trish-groves-let-spirit-take-you-towards-much-clearer-trial-protocols/ on 1October 2012.
6. Altman DG, Furberg CD, Grimshaw JM, et al. Lead editorial:trials-using the opportunities of electronic publishing to improve the reporting of randomised trials. Trials, 2006, 7(23): 6.
7. Turner EH. A taxpayer-funded clinical trials registry and results database. PLoS Med, 2004, 1(3): e60.
8. Coultas D. Ethical considerations in the interpretation and communication of clinical trial results. Proc Am Thorac Soc, 2007, 4(2): 194-198.
9. Siegel JP. Editorial review of protocols for clinical trials. N Engl J Med, 1990, 323(19): 1355.
10. Murray GD. Research governance must focus on research training. BMJ, 2001, 322(7300): 1461-1462.
11. Chan AW. Access to clinical trial data. BMJ, 2011, 12(342): d80.
12. Miller JD. Registering clinical trial results: the next step. JAMA, 2010, 303(8): 773-774.
13. Krle?a-Jeri? K, Chan AW, Dickersin K, et al. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ, 2005, 330(7497): 956-958.
14. Lassere M, Johnson K. The power of the protocol. Lancet, 2002, 360(9346): 1620-1622.
15. Getz KA, Zuckerman R, Cropp AB, et al. Measuring the incidence, causes, and repercussions of protocol amendments. Drug Inf J, 2011, 45: 265-275.
16. Public Citizen Health Research Group v. Food and Drug Administration, 964 F Supp. 413 (DDC 1997).
17. Tetzlaff JM, Chan AW, Kitchen J, et al. Guidelines for randomized clinical trial protocol content: a systematic review. Syst Rev, 2012, 1: 43.
18. Chan AW, Hróbjartsson A, Haahr MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA, 2004, 291(20): 2457-2465.
19. Smyth RM, Kirkham JJ, Jacoby A, et al. Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists. BMJ, 2011, 342: c7153.
20. Pildal J, Chan AW, Hróbjartsson A, et al. Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study. BMJ, 2005, 330 (7499): 1049.
21. Mhaskar R, Djulbegovic B, Magazin A, et al. Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols. J Clin Epidemiol, 2012, 65(6): 602-609.
22. Hróbjartsson A, Pildal J, Chan AW, et al. Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory. J Clin Epidemiol, 2009, 62(9): 967-973.
23. Scharf O, Colevas AD. Adverse event reporting in publications compared with sponsor database for cancer clinical trials. J Clin Oncol, 2006, 24(24): 3933-3938.
24. Chan AW, Hro´bjartsson A, Jørgensen KJ, et al. Discrepancies in sample size calculations and data analyses reported in randomized trials: comparison of publications with protocols. BMJ, 2008, 337: a2299.
25. Al-Marzouki S, Roberts I, Evans S, et al. Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet, 2008, 372(9634): 201.
26. Hernández AV, Steyerberg EW, Taylor GS, et al. Subgroup analysis and covariate adjustment in randomized clinical trials of traumatic brain injury: a systematic review. Neurosurgery, 2005, 57(6): 1244-1253.
27. Gøtzsche PC, Hróbjartsson A, Johansen HK, et al. Constraints on publication rights in industry-initiated clinical trials. JAMA, 2006, 295(14): 1645-1646.
28. Gøtzsche PC, Hróbjartsson A, Johansen HK, et al. Ghost authorship in industry-initiated randomised trials. PLoS Med, 2007, 4(1): e19.
29. Lundh A, Krogsbøll LT, Gøtzsche PC. Access to data in industry-sponsored trials. Lancet, 2011, 378(9808): 1995-1996.
30. Hopewell S, Dutton S, Yu LM, et al. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ, 2010, 340: c723.
31. Chan AW, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ, 2013, 346: e7586.
32. Moher D, Schulz KF, Simera I, et al. Guidance for developers of health research reporting guidelines. PLoS Med, 2010, 7: e1000217.
33. Tetzlaff JM, Moher D, Chan AW. Developing a guideline for clinical trial protocol content: Delphi consensus survey. Trials, 2012, 13: 176.
34. World Medical Association. WMA Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects. Accessed at www.wma.net/en/30publications/10policies/b3/index.html on 1 October 2012.
35. International Conference on Harmonisation. ICH Harmonised Tripartite Guideline: General Considerations for Clinical Trials: E8. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 17 July 1997. Accessed at www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E8/Step4/E8_Guideline.pdf on 1 October 2012.
36. International Conference on Harmonisation. ICH Harmonised Tripartite Guideline: Statistical Principles for Clinical Trials: E9. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 5 February 1998. Accessed at www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf on 1 October 2012.
37. International Conference on Harmonisation. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice: E6. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 10 June 1996. Accessed at www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf on 1 October 2012.
38. Grimes DA, Hubacher D, Nanda K, et al. The Good Clinical Practice guideline: a bronze standard for clinical research. Lancet, 2005, 366(9480): 172-174.
39. Sim I, Chan AW, Gülmezoglu AM, et al. Clinical trial registration: transparency is the watchword. Lancet, 2006, 367(9523): 1631-1633.
40. Laine C, De Angelis C, Delamothe T, et al. Clinical trial registration: looking back and moving ahead. Ann Intern Med, 2007, 147: 275-277.
41. Food and Drug Administration Amendments Act of 2007, HR 2580, 110th Congress, 1st Sess, Title VIII, §801 (2007). Expanded Clinical Trial Registry Data Bank. Accessed at www.govtrack.us/congress/billtext.xpd?bill_h110-3580 on 1 October 2012.
42. European Commission. Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004(2008/C 168/02). Official Journal of the European Union. 2008, 51: 3-4.
43. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med, 2010, 152(11): 726-732.
44. National Research Council. A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. Washington, DC: National Academies Pr; 2010.
45. Chan AW. Out of sight but not out of mind: how to search for unpublished clinical trial evidence. BMJ, 2012, 344: d8013.
46. Wieseler B, Kerekes MF, Vervoelgyi V, et al. Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications. BMJ, 2012, 344: d8141.
47. Reveiz L, Chan AW, Krle?a-Jeri? K, et al. Reporting of methodologic information on trial registries for quality assessment: a study of trial records retrieved from the WHO search portal. PLoS One, 2010, 5(8): e12484.
48. Dwan K, Altman DG, Cresswell L, et al. Comparison of protocols and registry entries to published reports for randomized controlled trials. Cochrane Database Syst Rev. 2011: MR000031.
49. Dwan K, Altman DG, Arnaiz JA, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One, 2008, 3(8): e3081.
50. GlaxoSmithKline. Public disclosure of clinical research. Global Public Policy Issues. October 2011. Accessed at www.gsk.com/policies/GSK-on-disclosure-of-clinical-trial-information.pdf on 1 October 2012.
51. Turner L, Shamseer L, Altman DG, et al. Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review. Syst Rev, 2012, 1: 60.

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《中國循證醫學雜志》

SPIRIT 2013聲明：定義臨床研究方案的標準條目△

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《中國循證醫學雜志》

SPIRIT 2013聲明：定義臨床研究方案的標準條目△

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