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Volumn 1, Issue 1, 2012, Pages

Guidelines for randomized clinical trial protocol content: A systematic review

Author keywords

Clinical trials; Protocols; Randomized controlled trials; Reporting guideline; SPIRIT initiative; Systematic review

Indexed keywords

ARTICLE; BOOK; CLINICAL PROTOCOL; CLINICAL STUDY; CONTENT VALIDITY; HUMAN; INSTITUTIONAL REVIEW; METHODOLOGY; PRACTICE GUIDELINE; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SCIENTIFIC LITERATURE; SYSTEMATIC REVIEW; REVIEW; STANDARD;

EID: 84871732774     PISSN: None     EISSN: 20464053     Source Type: Journal    
DOI: 10.1186/2046-4053-1-43     Document Type: Article
Times cited : (56)

References (93)
  • 1
    • 33644931936 scopus 로고    scopus 로고
    • Bias in clinical intervention research
    • 10.1093/aje/kwj069, 16443796
    • Gluud LL. Bias in clinical intervention research. Am J Epidemiol 2006, 163:493-501. 10.1093/aje/kwj069, 16443796.
    • (2006) Am J Epidemiol , vol.163 , pp. 493-501
    • Gluud, L.L.1
  • 3
    • 4844223081 scopus 로고    scopus 로고
    • Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research
    • Chan A-W, Krleža-Jeric K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. Can Med Assoc J 2004, 171:735-740.
    • (2004) Can Med Assoc J , vol.171 , pp. 735-740
    • Chan, A.-W.1    Krleža-Jeric, K.2    Schmid, I.3    Altman, D.G.4
  • 4
    • 17144387322 scopus 로고    scopus 로고
    • Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors
    • 10.1136/bmj.38356.424606.8F, 555875, 15681569
    • Chan AW, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ 2005, 330:753. 10.1136/bmj.38356.424606.8F, 555875, 15681569.
    • (2005) BMJ , vol.330 , pp. 753
    • Chan, A.W.1    Altman, D.G.2
  • 6
    • 0038439242 scopus 로고    scopus 로고
    • Pharmaceutical industry sponsorship and research outcome and quality: systematic review
    • 10.1136/bmj.326.7400.1167, 156458, 12775614
    • Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003, 326:1167-1170. 10.1136/bmj.326.7400.1167, 156458, 12775614.
    • (2003) BMJ , vol.326 , pp. 1167-1170
    • Lexchin, J.1    Bero, L.A.2    Djulbegovic, B.3    Clark, O.4
  • 7
    • 77957662045 scopus 로고    scopus 로고
    • Lancet: Information for authors http://download.thelancet.com/flatcontentassets/authors/lancet-information-for-authors.pdf.
    • Lancet: Information for authors
  • 11
    • 2442692780 scopus 로고    scopus 로고
    • Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles
    • 10.1001/jama.291.20.2457, 15161896
    • Chan AW, Hróbjartsson 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, 291:2457-2465. 10.1001/jama.291.20.2457, 15161896.
    • (2004) JAMA , vol.291 , pp. 2457-2465
    • Chan, A.W.1    Hróbjartsson, A.2    Haahr, M.T.3    Gøtzsche, P.C.4    Altman, D.G.5
  • 12
    • 18444370570 scopus 로고    scopus 로고
    • Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study
    • 10.1136/bmj.38414.422650.8F, 557221, 15817527
    • Pildal J, Chan AW, Hróbjartsson 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. 10.1136/bmj.38414.422650.8F, 557221, 15817527.
    • (2005) BMJ , vol.330 , pp. 1049
    • Pildal, J.1    Chan, A.W.2    Hróbjartsson, A.3    Forfang, E.4    Altman, D.G.5    Gøtzsche, P.C.6
  • 13
    • 56749126001 scopus 로고    scopus 로고
    • Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols
    • 10.1136/bmj.a2299, 2600604, 19056791
    • Chan AW, Hróbjartsson 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. 10.1136/bmj.a2299, 2600604, 19056791.
    • (2008) BMJ , vol.337
    • Chan, A.W.1    Hróbjartsson, A.2    Jørgensen, K.J.3    Gøtzsche, P.C.4    Altman, D.G.5
  • 14
    • 33846689371 scopus 로고    scopus 로고
    • Ghost authorship in industry-initiated randomised trials
    • 10.1371/journal.pmed.0040019, 1769411, 17227134
    • Gøtzsche P, Hróbjartsson A, Johansen H, Haahr M, Altman D, Chan A. Ghost authorship in industry-initiated randomised trials. PLoS Med 2007, 4:e19. 10.1371/journal.pmed.0040019, 1769411, 17227134.
    • (2007) PLoS Med , vol.4
    • Gøtzsche, P.1    Hróbjartsson, A.2    Johansen, H.3    Haahr, M.4    Altman, D.5    Chan, A.6
  • 15
    • 29244476263 scopus 로고    scopus 로고
    • Subgroup analysis and covariate adjustment in randomized clinical trials of traumatic brain injury: a systematic review
    • Hernández 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, 57:1244-1253.
    • (2005) Neurosurgery , vol.57 , pp. 1244-1253
    • Hernández, A.V.1    Steyerberg, E.W.2    Taylor, G.S.3    Marmarou, A.4    Habbema, J.D.5    Maas, A.I.6
  • 16
    • 56749097839 scopus 로고    scopus 로고
    • Bias, spin, and misreporting: Time for full access to trial protocols and results
    • 10.1371/journal.pmed.0050230, 2586359, 19067481
    • Chan A-W. Bias, spin, and misreporting: Time for full access to trial protocols and results. PLoS Med 2008, 5:e230. 10.1371/journal.pmed.0050230, 2586359, 19067481.
    • (2008) PLoS Med , vol.5
    • Chan, A.-W.1
  • 17
    • 78751694177 scopus 로고    scopus 로고
    • Access to clinical trial data
    • 10.1136/bmj.d80, 21228020
    • Chan A-W. Access to clinical trial data. BMJ 2011, 342:d80. 10.1136/bmj.d80, 21228020.
    • (2011) BMJ , vol.342
    • Chan, A.-W.1
  • 20
    • 46749106006 scopus 로고    scopus 로고
    • Guidelines for reporting health research: the EQUATOR network's survey of guideline authors
    • 10.1371/journal.pmed.0050139, 2443184, 18578566
    • Simera I, Altman DG, Moher D, Schulz KF, Hoey J. Guidelines for reporting health research: the EQUATOR network's survey of guideline authors. PLoS Med 2008, 5:e139. 10.1371/journal.pmed.0050139, 2443184, 18578566.
    • (2008) PLoS Med , vol.5
    • Simera, I.1    Altman, D.G.2    Moher, D.3    Schulz, K.F.4    Hoey, J.5
  • 21
    • 1642400145 scopus 로고    scopus 로고
    • CONSORT statement: extension to cluster randomised trials
    • 10.1136/bmj.328.7441.702, 381234, 15031246, CONSORT group
    • Campbell MK, Elbourne DR, Altman DG, CONSORT group CONSORT statement: extension to cluster randomised trials. BMJ 2004, 328:702-708. 10.1136/bmj.328.7441.702, 381234, 15031246, CONSORT group.
    • (2004) BMJ , vol.328 , pp. 702-708
    • Campbell, M.K.1    Elbourne, D.R.2    Altman, D.G.3
  • 23
    • 40049097858 scopus 로고    scopus 로고
    • Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments
    • for the CONSORT group
    • Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT group Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. Ann Intern Med 2008, 148:W60-W66. for the CONSORT group.
    • (2008) Ann Intern Med , vol.148
    • Boutron, I.1    Moher, D.2    Altman, D.G.3    Schulz, K.4    Ravaud, P.5
  • 24
    • 33644884271 scopus 로고    scopus 로고
    • Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement
    • Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med 2006, 144:364-367.
    • (2006) Ann Intern Med , vol.144 , pp. 364-367
    • Gagnier, J.J.1    Boon, H.2    Rochon, P.3    Moher, D.4    Barnes, J.5    Bombardier, C.6
  • 25
    • 68049122102 scopus 로고    scopus 로고
    • Preferred Reporting Items for Systematic reviews and Meta-Analyses: the PRISMA statement
    • 10.1371/journal.pmed.1000097, 2707599, 19621072, The PRISMA Group
    • Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group Preferred Reporting Items for Systematic reviews and Meta-Analyses: the PRISMA statement. PLoS Med 2009, 6:e1000097. 10.1371/journal.pmed.1000097, 2707599, 19621072, The PRISMA Group.
    • (2009) PLoS Med , vol.6
    • Moher, D.1    Liberati, A.2    Tetzlaff, J.3    Altman, D.G.4
  • 26
    • 36849065071 scopus 로고    scopus 로고
    • STROBE Initiative: The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies
    • 10.1016/S0140-6736(07)61602-X, 18064739
    • von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. STROBE Initiative: The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet 2007, 370:1453-1457. 10.1016/S0140-6736(07)61602-X, 18064739.
    • (2007) Lancet , vol.370 , pp. 1453-1457
    • von Elm, E.1    Altman, D.G.2    Egger, M.3    Pocock, S.J.4    Gøtzsche, P.C.5    Vandenbroucke, J.P.6
  • 27
    • 77950679021 scopus 로고    scopus 로고
    • CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials
    • 10.1371/journal.pmed.1000251, 2844794, 20352064, CONSORT Group
    • Schulz KF, Altman DG, Moher D, CONSORT Group CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med 2010, 7:e1000251. 10.1371/journal.pmed.1000251, 2844794, 20352064, CONSORT Group.
    • (2010) PLoS Med , vol.7
    • Schulz, K.F.1    Altman, D.G.2    Moher, D.3
  • 28
    • 84868114230 scopus 로고    scopus 로고
    • The influence of CONSORT on the quality of reporting of randomised controlled trials: an updated review
    • Turner L, Moher D, Shamseer L, Weeks L, Peters J, Plint A, Altman DG, Schulz KF. The influence of CONSORT on the quality of reporting of randomised controlled trials: an updated review. Trials 2011, 12(Suppl 1):A47.
    • (2011) Trials , vol.12 , Issue.SUPPL. 1
    • Turner, L.1    Moher, D.2    Shamseer, L.3    Weeks, L.4    Peters, J.5    Plint, A.6    Altman, D.G.7    Schulz, K.F.8
  • 30
    • 33748671821 scopus 로고    scopus 로고
    • Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review
    • Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, Gaboury I. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust 2006, 185:263-267.
    • (2006) Med J Aust , vol.185 , pp. 263-267
    • Plint, A.C.1    Moher, D.2    Morrison, A.3    Schulz, K.4    Altman, D.G.5    Hill, C.6    Gaboury, I.7
  • 31
    • 77649093946 scopus 로고    scopus 로고
    • Guidance for developers of health research reporting guidelines
    • Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of health research reporting guidelines. PLoS Med 2009, 7:e1000217.
    • (2009) PLoS Med , vol.7
    • Moher, D.1    Schulz, K.F.2    Simera, I.3    Altman, D.G.4
  • 32
    • 33751501016 scopus 로고    scopus 로고
    • Managing database overlap in systematic reviews using Batch Citation Matcher: case studies using Scopus
    • Sampson M, McGowan J, Cogo E, Horsley T. Managing database overlap in systematic reviews using Batch Citation Matcher: case studies using Scopus. J Med Libr Assoc 2006, 94:461463.
    • (2006) J Med Libr Assoc , vol.94 , pp. 461463
    • Sampson, M.1    McGowan, J.2    Cogo, E.3    Horsley, T.4
  • 33
    • 84888054177 scopus 로고    scopus 로고
    • Amazon http://www.Amazon.com.
    • Amazon
  • 34
    • 84888051238 scopus 로고    scopus 로고
    • WorldCat www.WorldCat.org.
    • WorldCat
  • 35
    • 18744376037 scopus 로고    scopus 로고
    • Public health. Increasing international gaps in health-related publications
    • 10.1126/science.1108705, 15890863
    • Paraje G, Sadana R, Karam G. Public health. Increasing international gaps in health-related publications. Science 2005, 308:959-960. 10.1126/science.1108705, 15890863.
    • (2005) Science , vol.308 , pp. 959-960
    • Paraje, G.1    Sadana, R.2    Karam, G.3
  • 36
    • 84876198136 scopus 로고    scopus 로고
    • Clinical Data Interchange Standards Consortium (CDISC)
    • Clinical Data Interchange Standards Consortium (CDISC) Protocol Representation Model http://www.cdisc.org/protocol, Clinical Data Interchange Standards Consortium (CDISC).
    • Protocol Representation Model
  • 39
    • 0017538244 scopus 로고
    • Recommendation plan for research protocol. FDI Commission on Dental Products, Instruments, Equipment and Therapeutic Agents (COMIET), G.T. Clinical trials. The French version: INCOGUDET]
    • Working group of the Commission on Dental Materials IEaT
    • Working group of the Commission on Dental Materials IEaT Recommendation plan for research protocol. FDI Commission on Dental Products, Instruments, Equipment and Therapeutic Agents (COMIET), G.T. Clinical trials. The French version: INCOGUDET]. Int Dent J 1977, 27:299-300. Working group of the Commission on Dental Materials IEaT.
    • (1977) Int Dent J , vol.27 , pp. 299-300
  • 40
    • 0017471821 scopus 로고
    • Recommended outline for a research protocol. Prepared by a working group of the Commission on Dental Materials, Instruments, Equipment and Therapeutics
    • Working group of the Commission on Dental Materials IEaT
    • Working group of the Commission on Dental Materials IEaT Recommended outline for a research protocol. Prepared by a working group of the Commission on Dental Materials, Instruments, Equipment and Therapeutics. Int Dent J 1977, 27:44-45. Working group of the Commission on Dental Materials IEaT.
    • (1977) Int Dent J , vol.27 , pp. 44-45
  • 41
    • 1542427422 scopus 로고    scopus 로고
    • International ethical guidelines for biomedical research involving human subjects
    • Council for International Organizations of Medical Sciences
    • Council for International Organizations of Medical Sciences International ethical guidelines for biomedical research involving human subjects. Bull Med Ethics 2002, 182:17-23. Council for International Organizations of Medical Sciences.
    • (2002) Bull Med Ethics , vol.182 , pp. 17-23
  • 42
    • 0003433351 scopus 로고    scopus 로고
    • Geneva: Council for International Organizations of Medical Sciences (CIOMS), Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO)
    • Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO) International Ethical Guidelines for Biomedical Research Involving Human Subjects 2002, Geneva: Council for International Organizations of Medical Sciences (CIOMS), Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO).
    • (2002) International Ethical Guidelines for Biomedical Research Involving Human Subjects
  • 44
    • 84876170582 scopus 로고    scopus 로고
    • NHS Department of Health [UK]
    • NHS Department of Health [UK] Clinical trials toolkit http://www.ct-toolkit.ac.uk/_db/_documents/Protocol.pdf, NHS Department of Health [UK].
    • Clinical trials toolkit
  • 45
    • 34547273241 scopus 로고    scopus 로고
    • NorthStar, a support tool for the design and evaluation of quality improvement interventions in healthcare
    • 10.1186/1748-5908-2-19, 1913538, 17594495
    • Akl EA, Treweek S, Foy R, Francis J, Oxman AD. NorthStar, a support tool for the design and evaluation of quality improvement interventions in healthcare. Implement Sci 2007, 2:19. 10.1186/1748-5908-2-19, 1913538, 17594495.
    • (2007) Implement Sci , vol.2 , pp. 19
    • Akl, E.A.1    Treweek, S.2    Foy, R.3    Francis, J.4    Oxman, A.D.5
  • 46
    • 33749241276 scopus 로고    scopus 로고
    • The Trial Protocol Tool: The PRACTIHC software tool that supported the writing of protocols for pragmatic randomized controlled trials
    • PRACTIHC C. 10.1016/j.jclinepi.2005.12.019, 17027422
    • Treweek S, McCormack K, Abalos E, Campbell M, Ramsay C, Zwarenstein M, PRACTIHC C. The Trial Protocol Tool: The PRACTIHC software tool that supported the writing of protocols for pragmatic randomized controlled trials. J Clin Epidemiol 2006, 59:1127-1133. 10.1016/j.jclinepi.2005.12.019, 17027422.
    • (2006) J Clin Epidemiol , vol.59 , pp. 1127-1133
    • Treweek, S.1    McCormack, K.2    Abalos, E.3    Campbell, M.4    Ramsay, C.5    Zwarenstein, M.6
  • 47
    • 59149102922 scopus 로고    scopus 로고
    • Guidelines for writing a research project synopsis or protocol
    • 10.4103/0378-6323.45136, 19172017
    • Betkerur J. Guidelines for writing a research project synopsis or protocol. Indian J Dermatol Venereol Leprol 2008, 74:687-690. 10.4103/0378-6323.45136, 19172017.
    • (2008) Indian J Dermatol Venereol Leprol , vol.74 , pp. 687-690
    • Betkerur, J.1
  • 48
    • 1842845955 scopus 로고    scopus 로고
    • Manila: World Health Organization, Regional Office for the Western Pacific, World Health Organization
    • World Health Organization Health research methodology: A guide for training in research methods 2001, Manila: World Health Organization, Regional Office for the Western Pacific, World Health Organization.
    • (2001) Health research methodology: A guide for training in research methods
  • 49
    • 1842866250 scopus 로고    scopus 로고
    • Elements of medical research
    • Indrayan A. Elements of medical research. Indian J Med Res 2004, 119:93-100.
    • (2004) Indian J Med Res , vol.119 , pp. 93-100
    • Indrayan, A.1
  • 50
    • 0033796713 scopus 로고    scopus 로고
    • Important issues in planning and conducting multi-centre randomised trials in cancer and publishing their results
    • 10.1016/S1040-8428(00)00095-0, 10996520
    • Girling DJ. Important issues in planning and conducting multi-centre randomised trials in cancer and publishing their results. Crit Rev Oncol Hematol 2000, 36:13-25. 10.1016/S1040-8428(00)00095-0, 10996520.
    • (2000) Crit Rev Oncol Hematol , vol.36 , pp. 13-25
    • Girling, D.J.1
  • 51
    • 0029564558 scopus 로고
    • Design, management and handling of a randomized trial. [French]
    • Ivanov A, Van GM. Design, management and handling of a randomized trial. [French]. Bull Cancer 1995, Suppl 5:553s-557s.
    • (1995) Bull Cancer , vol.Suppl 5
    • Ivanov, A.1    Van, G.M.2
  • 52
    • 0028367260 scopus 로고
    • Guidelines for experimental studies
    • 10.1016/0109-5641(94)90021-3, 7995475
    • Moorhead JE, Rao PV, Anusavice KJ. Guidelines for experimental studies. Dent Mater 1994, 10:45-51. 10.1016/0109-5641(94)90021-3, 7995475.
    • (1994) Dent Mater , vol.10 , pp. 45-51
    • Moorhead, J.E.1    Rao, P.V.2    Anusavice, K.J.3
  • 53
    • 0018855621 scopus 로고
    • Guidelines for the preparation of E.R.T.C. cancer clinical trial protocols
    • Staquet M, Sylvester R, Jasmin C. Guidelines for the preparation of E.R.T.C. cancer clinical trial protocols. Eur J of Cancer (Oxford) 1980, 16:871-875.
    • (1980) Eur J of Cancer (Oxford) , vol.16 , pp. 871-875
    • Staquet, M.1    Sylvester, R.2    Jasmin, C.3
  • 54
    • 0017904096 scopus 로고
    • Aide-memoire for preparing a protocol
    • 10.1136/bmj.1.6121.1195, 1604243, 638692
    • Warren MD. Aide-memoire for preparing a protocol. Br Med J 1978, 1:1195-1196. 10.1136/bmj.1.6121.1195, 1604243, 638692.
    • (1978) Br Med J , vol.1 , pp. 1195-1196
    • Warren, M.D.1
  • 55
    • 0017780603 scopus 로고
    • Aide-memoire for preparing clinical trial protocols
    • 1607199, 861601
    • de Saintonge CD. Aide-memoire for preparing clinical trial protocols. Br Med J 1977, 1:1323-1324. 1607199, 861601.
    • (1977) Br Med J , vol.1 , pp. 1323-1324
    • de Saintonge, C.D.1
  • 56
    • 27644503212 scopus 로고    scopus 로고
    • A method for rapid, objective and structured evaluation (ROSE) of protocol of a randomised clinical trial
    • Malhotra S, Shafiq N, Pandhi P. A method for rapid, objective and structured evaluation (ROSE) of protocol of a randomised clinical trial. Bull, Postgrad Inst Med Ed Res, Chandigarh 2005, 39:22-26.
    • (2005) Bull, Postgrad Inst Med Ed Res, Chandigarh , vol.39 , pp. 22-26
    • Malhotra, S.1    Shafiq, N.2    Pandhi, P.3
  • 59
    • 70449723057 scopus 로고    scopus 로고
    • Development and implementation of clinical trial protocol templates at the National Institute of Allergy and Infectious Diseases
    • Protocol Template Working Group of the NIAID Clinical Research Subcommittee
    • Bridge H, Smolskis M, Bianchine P, Dixon DO, Kelly G, Herpin B, Tavel J, Protocol Template Working Group of the NIAID Clinical Research Subcommittee Development and implementation of clinical trial protocol templates at the National Institute of Allergy and Infectious Diseases. Clin 2009, 6:386-391. Protocol Template Working Group of the NIAID Clinical Research Subcommittee.
    • (2009) Clin , vol.6 , pp. 386-391
    • Bridge, H.1    Smolskis, M.2    Bianchine, P.3    Dixon, D.O.4    Kelly, G.5    Herpin, B.6    Tavel, J.7
  • 60
    • 67650302839 scopus 로고    scopus 로고
    • Regulatory aspects for translating gene therapy research into the clinic
    • Laurencot CM, Ruppel S. Regulatory aspects for translating gene therapy research into the clinic. Methods Mol Biol 2009, 542:397-421.
    • (2009) Methods Mol Biol , vol.542 , pp. 397-421
    • Laurencot, C.M.1    Ruppel, S.2
  • 61
    • 0024294511 scopus 로고
    • Protocols: getting them right
    • O'Dowd T, Jones S. Protocols: getting them right. Practitioner 1988, 232:713-714.
    • (1988) Practitioner , vol.232 , pp. 713-714
    • O'Dowd, T.1    Jones, S.2
  • 63
    • 0021105968 scopus 로고
    • Code of practice for the clinical assessment of licensed medicinal products in general practice
    • British Medical Association, Royal College of General Practitioners and Association of the British Pharmaceutical Industry
    • British Medical Association, Royal College of General Practitioners and Association of the British Pharmaceutical Industry Code of practice for the clinical assessment of licensed medicinal products in general practice. Br Med J (Clin Res Ed) 1983, 286:1295-1297. British Medical Association, Royal College of General Practitioners and Association of the British Pharmaceutical Industry.
    • (1983) Br Med J (Clin Res Ed) , vol.286 , pp. 1295-1297
  • 64
    • 0025651501 scopus 로고
    • Therapeutic tests of the medicins a clinical protocol established on priority why?
    • Souche A, Zekri J-R, Thermoz P. Therapeutic tests of the medicins a clinical protocol established on priority why?. Psychologie Medicale 1990, 22:1483-1484.
    • (1990) Psychologie Medicale , vol.22 , pp. 1483-1484
    • Souche, A.1    Zekri, J.-R.2    Thermoz, P.3
  • 65
    • 0024352255 scopus 로고
    • Randomized clinical trials. Part I. Principles, protocol and organization
    • Pignon JP, Doyon F. Randomized clinical trials. Part I. Principles, protocol and organization. Reanim Soins Intensifs Med D'Urgence 1989, 5:239-243.
    • (1989) Reanim Soins Intensifs Med D'Urgence , vol.5 , pp. 239-243
    • Pignon, J.P.1    Doyon, F.2
  • 66
    • 73049143873 scopus 로고
    • Controlled clinical trials: Monday's count-down for Tuesday's launching
    • Schneidermann M. Controlled clinical trials: Monday's count-down for Tuesday's launching. J New Drugs 1961, 1:250-255.
    • (1961) J New Drugs , vol.1 , pp. 250-255
    • Schneidermann, M.1
  • 67
    • 0037392252 scopus 로고    scopus 로고
    • Experimental study design and grant writing in eight steps and 28 questions
    • 10.1046/j.1365-2923.2003.01468.x, 12654123
    • Bordage G, Dawson B. Experimental study design and grant writing in eight steps and 28 questions. Med Educ 2003, 37:376-385. 10.1046/j.1365-2923.2003.01468.x, 12654123.
    • (2003) Med Educ , vol.37 , pp. 376-385
    • Bordage, G.1    Dawson, B.2
  • 68
    • 0024825631 scopus 로고
    • Neuroscience nursing: designing the research proposal
    • 10.1097/01376517-198912000-00015, 2532675
    • Williams AM. Neuroscience nursing: designing the research proposal. J Neurosci Nurs 1989, 21:389-391. 10.1097/01376517-198912000-00015, 2532675.
    • (1989) J Neurosci Nurs , vol.21 , pp. 389-391
    • Williams, A.M.1
  • 69
    • 84876191221 scopus 로고    scopus 로고
    • Centers for Disease Control and Prevention
    • Centers for Disease Control and Prevention Developing a protocol: a guide for CDC investigators http://www.umdnj.edu/hsweb/Forms/Forms_Developing_a_Protocol.pdf, Centers for Disease Control and Prevention.
    • Developing a protocol: a guide for CDC investigators
  • 73
    • 84876195535 scopus 로고    scopus 로고
    • Merck investigator studies program (MISP)
    • Merck investigator studies program (MISP) Protocol template. Requirements for submitting a full proposal http://merckresearch.net/doc/MISP%20Protocol%20Template.doc, Merck investigator studies program (MISP).
    • Protocol template. Requirements for submitting a full proposal
  • 79
    • 84888017244 scopus 로고    scopus 로고
    • A guide for writing a protocol for a clinical trial
    • Ahmed AM. A guide for writing a protocol for a clinical trial. Sudan J Public Health 2010, 5:23-28.
    • (2010) Sudan J Public Health , vol.5 , pp. 23-28
    • Ahmed, A.M.1
  • 82
    • 0003577283 scopus 로고    scopus 로고
    • 21CFR312.23, Food and Drug Administration
    • Food and Drug Administration Code of Federal Regulations: Food and Drugs 2002, 21CFR312.23, Food and Drug Administration.
    • (2002) Code of Federal Regulations: Food and Drugs
  • 84
    • 40949113623 scopus 로고    scopus 로고
    • Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study
    • 10.1136/bmj.39465.451748.AD, 2267990, 18316340
    • Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ 2008, 336:601-605. 10.1136/bmj.39465.451748.AD, 2267990, 18316340.
    • (2008) BMJ , vol.336 , pp. 601-605
    • Wood, L.1    Egger, M.2    Gluud, L.L.3    Schulz, K.F.4    Jüni, P.5    Altman, D.G.6    Gluud, C.7    Martin, R.M.8    Wood, A.J.9    Sterne, J.A.10
  • 86
    • 34548595472 scopus 로고    scopus 로고
    • Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials
    • 10.1093/ije/dym087, 17517809
    • Pildal J, Hróbjartsson A, Jørgensen KJ, Hilden J, Altman DG, Gøtzsche PC. Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials. Int J Epidemiol 2007, 36:847-857. 10.1093/ije/dym087, 17517809.
    • (2007) Int J Epidemiol , vol.36 , pp. 847-857
    • Pildal, J.1    Hróbjartsson, A.2    Jørgensen, K.J.3    Hilden, J.4    Altman, D.G.5    Gøtzsche, P.C.6
  • 88
    • 0037460196 scopus 로고    scopus 로고
    • Scope and impact of financial conflicts of interest in biomedical research: a systematic review
    • 10.1001/jama.289.4.454, 12533125
    • Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003, 289:454-465. 10.1001/jama.289.4.454, 12533125.
    • (2003) JAMA , vol.289 , pp. 454-465
    • Bekelman, J.E.1    Li, Y.2    Gross, C.P.3
  • 89
    • 0037014942 scopus 로고    scopus 로고
    • Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ
    • 10.1136/bmj.325.7358.249, 117638, 12153921
    • Kjaergard LL, Is-Nielsen B. Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ. BMJ 2002, 325:249. 10.1136/bmj.325.7358.249, 117638, 12153921.
    • (2002) BMJ , vol.325 , pp. 249
    • Kjaergard, L.L.1    Is-Nielsen, B.2
  • 90
    • 21344435080 scopus 로고    scopus 로고
    • Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding?
    • Fergusson D, Glass KC, Hutton B, Shapiro S. Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding?. Clin 2005, 2:218-229.
    • (2005) Clin , vol.2 , pp. 218-229
    • Fergusson, D.1    Glass, K.C.2    Hutton, B.3    Shapiro, S.4
  • 91
    • 54349087821 scopus 로고    scopus 로고
    • Where is the supporting evidence for treating mild to moderate chronic obstructive pulmonary disease exacerbations with antibiotics? A systematic review
    • 10.1186/1741-7015-6-28, 2569060, 18847478
    • Puhan MA, Vollenweider D, Steurer J, Bossuyt PM, ter Riet G. Where is the supporting evidence for treating mild to moderate chronic obstructive pulmonary disease exacerbations with antibiotics? A systematic review. BMC Med 2008, 6:28. 10.1186/1741-7015-6-28, 2569060, 18847478.
    • (2008) BMC Med , vol.6 , pp. 28
    • Puhan, M.A.1    Vollenweider, D.2    Steurer, J.3    Bossuyt, P.M.4    ter Riet, G.5
  • 93
    • 84876172100 scopus 로고    scopus 로고
    • Strengthening the credibility of clinical research
    • Editorial
    • Editorial Strengthening the credibility of clinical research. Lancet 2011, 375:1226. Editorial.
    • (2011) Lancet , vol.375 , pp. 1226


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