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SPIRIT 2013 Bildirisi: Klinik Deneyler İçin Standart Protokol Maddelerinin Tanımlanması

Yıl 2021, Cilt: 8 Sayı: 1, 117 - 127, 31.03.2021
https://doi.org/10.31125/hunhemsire.908072

Öz

Klinik deney protokolü deneyin planlanması, yürütülmesi, raporlanması ve değerlendirilmesinde temel bir dayanak olarak hizmet eder. Ancak deney protokolleri ve mevcut protokol rehberleri, içerik ve kalite yönünden oldukça fazla çeşitlilik göstermektedir. Bu makale klinik deney protokolünün asgari içeriği için bir rehber olan SPIRIT 2013’ün (Standard Protocol Items: Recommendations for Interventional Trials-Standart Protokol Maddeleri: Girişimsel Deneyler için Öneriler) sistematik olarak geliştirilmesini ve kapsamını tanımlamaktadır. 33-maddelik SPIRIT kontrol listesi tüm klinik deney protokollerine uygulanabilir ve şekilden ziyade içeriğe odaklanır. Kontrol listesi, tüm planlananların tarif edilmesini önerir; bir deneyin nasıl tasarlanacağını ya da yürütüleceğini içermez. SPIRIT önerileri, anahtar içerik için rehberlik sağlayarak, yüksek kaliteli protokol taslağı hazırlanmasını kolaylaştırmayı hedefler. SPIRIT’e bağlı kalmak aynı zamanda araştırmacılar, deney katılımcıları, hastalar, sponsorlar, ödenek sağlayanlar, araştırma etik komiteleri ya da kurumsal hakem kurulları, hakemler, dergiler, deney kayıt merkezi, politikacılar, düzenleyiciler ve diğer anahtar paydaşlar için deney protokolünün şeffaflığını ve bütünlüğünü artırır.

Kaynakça

  • 1. Rennie D. Trial registration: A great idea switches from ignored to irresistible. JAMA. 2004;292:1359-62.
  • 2. Strengthening the credibility of clinical research [Editorial]. Lancet. 2010;375:1225.
  • 3. Summerskill W, Collingridge D, Frankish H. Protocols, probity, and publication. Lancet. 2009;373:992.
  • 4. Jones G, Abbasi K. Trial protocols at the BMJ [Editorial]. BMJ. 2004;329:1360.
  • 5. Groves T. Let SPIRIT take you... towards much clearer trial protocols. BMJ Group Blogs. [Internet]. 2009 [Erişim Tarihi September 2009]. Erişim adresi: http://blogs.bmj.com/bmj/2009 /09/25/trish-groves-let-spirit-take-you-towards-much-clearer-trial-protocols/ on 1 October 2012.
  • 6. Altman DG, Furberg CD, Grimshaw JM, Rothwell PM. Lead editorial: trials-using the opportunities of electronic publishing to improve the reporting of randomised trials [Editorial]. Trials. 2006;7:6.
  • 7. Turner EH. A taxpayer-funded clinical trials registry and results database [Editorial]. PLoS Med. 2004;1:e60.
  • 8. Coultas D. Ethical considerations in the interpretation and communication of clinical trial results. Proc Am Thorac Soc. 2007;4:194-8.
  • 9. Siegel JP. Editorial review of protocols for clinical trials [Letter]. N Engl J Med. 1990;323:1355.
  • 10. Murray GD. Research governance must focus on research training. BMJ. 2001;322:1461-2.
  • 11. Chan A-W. Access to clinical trial data [Editorial]. BMJ. 2011;342:d80.
  • 12. Miller JD. Registering clinical trial results: the next step. JAMA. 2010;303:773-4.
  • 13. Krlezˇa-Jeric´ K, Chan A-W, Dickersin K, Sim I, Grimshaw J, Gluud C. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ. 2005;330:956-8.
  • 14. Lassere M, Johnson K. The power of the protocol. Lancet. 2002;360:1620-2.
  • 15. Getz KA, Zuckerman R, Cropp AB, Hindle AL, Krauss R, Kaitin KI. Measuring the incidence, causes, and repercussions of protocol amendments. Drug Inf J. 2011;45:265-75.
  • 16. Public Citizen Health Research Group v. Food and Drug Administration. 1997; 964:F Supp. 413
  • 17. Tetzlaff JM, Chan A-W, Kitchen J, Sampson M, Tricco A, Moher D. Guidelines for randomized clinical trial protocol content: a systematic review. Syst Rev. 2012;1:43. 18. Chan A-W, Hro´bjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: Comparison of protocols to published articles. JAMA. 2004;291:2457-65.
  • 19. Smyth RM, Kirkham JJ, Jacoby A, Altman DG, Gamble C, Williamson PR. Frequency and reasons for outcome reporting bias in clinical trials: Interviews with trialists. BMJ. 2011;342:c7153.
  • 20. Pildal J, Chan A-W, Hro´bjartsson A, Forfang E, Altman DG, Gøtzsche PC. Comparison of descriptions of allocation concealment in trial protocols and the published reports: Cohort study. BMJ. 2005;330:1049.
  • 21. Mhaskar R, Djulbegovic B, Magazin A, Soares HP, Kumar A. Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols. J Clin Epidemiol. 2012;65:602-9.
  • 22. Hro´bjartsson A, Pildal J, Chan A-W, Haahr MT, Altman DG, Gøtzsche PC. Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory. J Clin Epidemiol. 2009;62:967-73.
  • 23. Scharf O, Colevas AD. Adverse event reporting in publications compared with sponsor database for cancer clinical trials. J Clin Oncol. 2006;24:3933-8.
  • 24. Chan A-W, Hro´bjartsson A, Jørgensen KJ, Gøtzsche PC, Altman DG. Discrepancies in sample size calculations and data analyses reported in randomised trials: Comparison of publications with protocols. BMJ. 2008;337: a2299.
  • 25. Al-Marzouki S, Roberts I, Evans S, Marshall T. Selective reporting in clinical trials: Analysis of trial protocols accepted by The Lancet [Letter]. Lancet. 2008;372:201.
  • 26. Herna´ndez AV, Steyerberg EW, Taylor GS, Marmarou A, Habbema JD, Maas AI. Subgroup analysis and covariate adjustment in randomized clinical trials of traumatic brain injury: a systematic review. Neurosurgery. 2005;57:1244- 53.
  • 27. Gøtzsche PC, Hro´bjartsson A, Johansen HK, Haahr MT, Altman DG, Chan A-W. Constraints on publication rights in industry-initiated clinical trials [Letter]. JAMA. 2006;295:1645-6.
  • 28. Gøtzsche PC, Hro´bjartsson A, Johansen HK, Haahr MT, Altman DG, Chan A-W. Ghost authorship in industry-initiated randomised trials. PLoS Med. 2007;4:e19.
  • 29. Lundh A, Krogsbøll LT, Gøtzsche PC. Access to data in industry-sponsored trials [Letter]. Lancet. 2011;378:1995-6.
  • 30. Hopewell S, Dutton S, Yu LM, Chan A-W, Altman DG. The quality of reports of randomised trials in 2000 and 2006: Comparative study of articles indexed in PubMed. BMJ. 2010;340:c723.
  • 31. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.
  • 32. Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of health research reporting guidelines. PLoS Med. 2010;7:e1000217.
  • 33. Tetzlaff JM, Moher D, Chan A-W. 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. [Internet]. 2012 [Erişim Tarihi 1 October 2012]. Erişim adresi: www.wma.net /en/30publications/10policies/b3/index.html on.
  • 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. [Internet]. 1997 [Erişim Tarihi 17 July 1997]. Erişim adresi: www.ich.org/fileadmin/Public_ Web_Site/ICH_Products/Guidelines/Efficacy/E8/Step4/E8_Guideline.pdf
  • 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. [Internet]. 1997 [Erişim Tarihi 5 February 1998]. Erişim adresi: 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. [Internet]. 1996 [Erişim Tarihi 10 June 1996]. Erişim adresi:www.ich.org/fileadmin/Public_ Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf
  • 38. Grimes DA, Hubacher D, Nanda K, Schulz KF, Moher D, Altman DG. The Good Clinical Practice guideline: a bronze standard for clinical research. Lancet. 2005;366:172-4.
  • 39. Sim I, Chan A-W, Gu¨lmezoglu AM, Evans T, Pang T. Clinical trial registration: transparency is the watchword. Lancet. 2006;367:1631-3.
  • 40. Laine C, De Angelis C, Delamothe T, Drazen JM, Frizelle FA, Haug C, et al. Clinical trial registration: looking back and moving ahead [Editorial]. Ann Intern Med. 2007;147:275-7.
  • 41. Food and Drug Administration Amendments Act of 2007, HR 2580, 110th Congress, 1st Sess, Title VIII, §801. Expanded Clinical Trial Registry Data Bank. [Internet]. 2007 [Erişim Tarihi 1 October 2012]. Erişim adresi: www.govtrack.us/congress/billtext.xpd?billh110-3580.
  • 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;152:726-32.
  • 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 A-W. 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, McGauran N, Kaiser T. 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 A-W, Krlezˇa-Jeric´ K, Granados CE, Pinart M, Etxeandia I, 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:e12484.
  • 48. Dwan K, Altman DG, Cresswell L, Blundell M, Gamble CL, Williamson PR. Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database Syst Rev. 2011:MR000031.
  • 49. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan A-W, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One. 2008;3:e3081.
  • 50. GlaxoSmithKline. Public disclosure of clinical research. Global Public Policy Issues. [Internet]. 2011 [Erişim Tarihi 1 October 2011]. Erişim adresi: www.gsk.com/policies/GSK-on-disclosure-of -clinical-trial-information.pdf
  • 51. Turner L, Shamseer L, Altman DG, Schulz KF, Moher D. 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.

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

Yıl 2021, Cilt: 8 Sayı: 1, 117 - 127, 31.03.2021
https://doi.org/10.31125/hunhemsire.908072

Öz

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

Kaynakça

  • 1. Rennie D. Trial registration: A great idea switches from ignored to irresistible. JAMA. 2004;292:1359-62.
  • 2. Strengthening the credibility of clinical research [Editorial]. Lancet. 2010;375:1225.
  • 3. Summerskill W, Collingridge D, Frankish H. Protocols, probity, and publication. Lancet. 2009;373:992.
  • 4. Jones G, Abbasi K. Trial protocols at the BMJ [Editorial]. BMJ. 2004;329:1360.
  • 5. Groves T. Let SPIRIT take you... towards much clearer trial protocols. BMJ Group Blogs. [Internet]. 2009 [Erişim Tarihi September 2009]. Erişim adresi: http://blogs.bmj.com/bmj/2009 /09/25/trish-groves-let-spirit-take-you-towards-much-clearer-trial-protocols/ on 1 October 2012.
  • 6. Altman DG, Furberg CD, Grimshaw JM, Rothwell PM. Lead editorial: trials-using the opportunities of electronic publishing to improve the reporting of randomised trials [Editorial]. Trials. 2006;7:6.
  • 7. Turner EH. A taxpayer-funded clinical trials registry and results database [Editorial]. PLoS Med. 2004;1:e60.
  • 8. Coultas D. Ethical considerations in the interpretation and communication of clinical trial results. Proc Am Thorac Soc. 2007;4:194-8.
  • 9. Siegel JP. Editorial review of protocols for clinical trials [Letter]. N Engl J Med. 1990;323:1355.
  • 10. Murray GD. Research governance must focus on research training. BMJ. 2001;322:1461-2.
  • 11. Chan A-W. Access to clinical trial data [Editorial]. BMJ. 2011;342:d80.
  • 12. Miller JD. Registering clinical trial results: the next step. JAMA. 2010;303:773-4.
  • 13. Krlezˇa-Jeric´ K, Chan A-W, Dickersin K, Sim I, Grimshaw J, Gluud C. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ. 2005;330:956-8.
  • 14. Lassere M, Johnson K. The power of the protocol. Lancet. 2002;360:1620-2.
  • 15. Getz KA, Zuckerman R, Cropp AB, Hindle AL, Krauss R, Kaitin KI. Measuring the incidence, causes, and repercussions of protocol amendments. Drug Inf J. 2011;45:265-75.
  • 16. Public Citizen Health Research Group v. Food and Drug Administration. 1997; 964:F Supp. 413
  • 17. Tetzlaff JM, Chan A-W, Kitchen J, Sampson M, Tricco A, Moher D. Guidelines for randomized clinical trial protocol content: a systematic review. Syst Rev. 2012;1:43. 18. Chan A-W, Hro´bjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: Comparison of protocols to published articles. JAMA. 2004;291:2457-65.
  • 19. Smyth RM, Kirkham JJ, Jacoby A, Altman DG, Gamble C, Williamson PR. Frequency and reasons for outcome reporting bias in clinical trials: Interviews with trialists. BMJ. 2011;342:c7153.
  • 20. Pildal J, Chan A-W, Hro´bjartsson A, Forfang E, Altman DG, Gøtzsche PC. Comparison of descriptions of allocation concealment in trial protocols and the published reports: Cohort study. BMJ. 2005;330:1049.
  • 21. Mhaskar R, Djulbegovic B, Magazin A, Soares HP, Kumar A. Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols. J Clin Epidemiol. 2012;65:602-9.
  • 22. Hro´bjartsson A, Pildal J, Chan A-W, Haahr MT, Altman DG, Gøtzsche PC. Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory. J Clin Epidemiol. 2009;62:967-73.
  • 23. Scharf O, Colevas AD. Adverse event reporting in publications compared with sponsor database for cancer clinical trials. J Clin Oncol. 2006;24:3933-8.
  • 24. Chan A-W, Hro´bjartsson A, Jørgensen KJ, Gøtzsche PC, Altman DG. Discrepancies in sample size calculations and data analyses reported in randomised trials: Comparison of publications with protocols. BMJ. 2008;337: a2299.
  • 25. Al-Marzouki S, Roberts I, Evans S, Marshall T. Selective reporting in clinical trials: Analysis of trial protocols accepted by The Lancet [Letter]. Lancet. 2008;372:201.
  • 26. Herna´ndez AV, Steyerberg EW, Taylor GS, Marmarou A, Habbema JD, Maas AI. Subgroup analysis and covariate adjustment in randomized clinical trials of traumatic brain injury: a systematic review. Neurosurgery. 2005;57:1244- 53.
  • 27. Gøtzsche PC, Hro´bjartsson A, Johansen HK, Haahr MT, Altman DG, Chan A-W. Constraints on publication rights in industry-initiated clinical trials [Letter]. JAMA. 2006;295:1645-6.
  • 28. Gøtzsche PC, Hro´bjartsson A, Johansen HK, Haahr MT, Altman DG, Chan A-W. Ghost authorship in industry-initiated randomised trials. PLoS Med. 2007;4:e19.
  • 29. Lundh A, Krogsbøll LT, Gøtzsche PC. Access to data in industry-sponsored trials [Letter]. Lancet. 2011;378:1995-6.
  • 30. Hopewell S, Dutton S, Yu LM, Chan A-W, Altman DG. The quality of reports of randomised trials in 2000 and 2006: Comparative study of articles indexed in PubMed. BMJ. 2010;340:c723.
  • 31. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.
  • 32. Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of health research reporting guidelines. PLoS Med. 2010;7:e1000217.
  • 33. Tetzlaff JM, Moher D, Chan A-W. 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. [Internet]. 2012 [Erişim Tarihi 1 October 2012]. Erişim adresi: www.wma.net /en/30publications/10policies/b3/index.html on.
  • 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. [Internet]. 1997 [Erişim Tarihi 17 July 1997]. Erişim adresi: www.ich.org/fileadmin/Public_ Web_Site/ICH_Products/Guidelines/Efficacy/E8/Step4/E8_Guideline.pdf
  • 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. [Internet]. 1997 [Erişim Tarihi 5 February 1998]. Erişim adresi: 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. [Internet]. 1996 [Erişim Tarihi 10 June 1996]. Erişim adresi:www.ich.org/fileadmin/Public_ Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf
  • 38. Grimes DA, Hubacher D, Nanda K, Schulz KF, Moher D, Altman DG. The Good Clinical Practice guideline: a bronze standard for clinical research. Lancet. 2005;366:172-4.
  • 39. Sim I, Chan A-W, Gu¨lmezoglu AM, Evans T, Pang T. Clinical trial registration: transparency is the watchword. Lancet. 2006;367:1631-3.
  • 40. Laine C, De Angelis C, Delamothe T, Drazen JM, Frizelle FA, Haug C, et al. Clinical trial registration: looking back and moving ahead [Editorial]. Ann Intern Med. 2007;147:275-7.
  • 41. Food and Drug Administration Amendments Act of 2007, HR 2580, 110th Congress, 1st Sess, Title VIII, §801. Expanded Clinical Trial Registry Data Bank. [Internet]. 2007 [Erişim Tarihi 1 October 2012]. Erişim adresi: www.govtrack.us/congress/billtext.xpd?billh110-3580.
  • 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;152:726-32.
  • 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 A-W. 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, McGauran N, Kaiser T. 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 A-W, Krlezˇa-Jeric´ K, Granados CE, Pinart M, Etxeandia I, 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:e12484.
  • 48. Dwan K, Altman DG, Cresswell L, Blundell M, Gamble CL, Williamson PR. Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database Syst Rev. 2011:MR000031.
  • 49. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan A-W, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One. 2008;3:e3081.
  • 50. GlaxoSmithKline. Public disclosure of clinical research. Global Public Policy Issues. [Internet]. 2011 [Erişim Tarihi 1 October 2011]. Erişim adresi: www.gsk.com/policies/GSK-on-disclosure-of -clinical-trial-information.pdf
  • 51. Turner L, Shamseer L, Altman DG, Schulz KF, Moher D. 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.
Toplam 50 adet kaynakça vardır.

Ayrıntılar

Birincil Dil Türkçe
Konular Sağlık Kurumları Yönetimi
Bölüm Makaleler
Yazarlar

Belgin Akın Bu kişi benim 0000-0002-8094-4110

Deniz Koçoğlu-tanyer Bu kişi benim 0000-0001-9496-8749

Yayımlanma Tarihi 31 Mart 2021
Gönderilme Tarihi 16 Eylül 2020
Yayımlandığı Sayı Yıl 2021 Cilt: 8 Sayı: 1

Kaynak Göster

Vancouver Akın B, Koçoğlu-tanyer D. SPIRIT 2013 Bildirisi: Klinik Deneyler İçin Standart Protokol Maddelerinin Tanımlanması. HUHEMFAD. 2021;8(1):117-2.