SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials△_Chinese Journal of Evidence-Based Medicine

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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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10.7507/1672-2531.20130256

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Citation： 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. SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials△. Chinese Journal of Evidence-Based Medicine, 2013, 13(12): 1501-1507. doi: 10.7507/1672-2531.20130256 Copy

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.	Krleža-Jerić 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, Krleža-Jerić 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. Krleža-Jerić 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, Krleža-Jerić 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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