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Volumn 381, Issue 9861, 2013, Pages 91-92

SPIRIT 2013: New guidance for content of clinical trial protocols

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIAL (TOPIC); EDITOR; EVIDENCE BASED PRACTICE; HEALTH CARE PERSONNEL; HUMAN; INTERNAL CONSISTENCY; INTERNET; MEDICAL DOCUMENTATION; MEDICAL INFORMATION; MEDICAL LITERATURE; NOTE; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROFESSIONAL STANDARD; QUALITY CONTROL; RESEARCH ETHICS;

EID: 84872094903     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(12)62160-6     Document Type: Note
Times cited : (233)

References (15)
  • 1
    • 84872075614 scopus 로고    scopus 로고
    • SPIRIT 2013 statement: Defining standard protocol items for clinical trials
    • in press
    • Chan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013; 158 (in press).
    • (2013) Ann Intern Med , pp. 158
    • Chan, A.-W.1    Tetzlaff, J.M.2    Altman, D.G.3
  • 3
    • 2442692780 scopus 로고    scopus 로고
    • Empirical evidence for selective reporting of outcomes in randomized trials: Comparison of protocols to published articles
    • Chan A-W, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004; 291: 2457-65.
    • (2004) JAMA , vol.291 , pp. 2457-2465
    • Chan, A.-W.1    Hrobjartsson, A.2    Haahr, M.T.3    Gotzsche, P.C.4    Altman, D.G.5
  • 4
    • 78751697239 scopus 로고    scopus 로고
    • Frequency and reasons for outcome reporting bias in clinical trials: Interviews with trialists
    • 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.
    • (2011) BMJ , vol.342
    • Smyth, R.M.1    Kirkham, J.J.2    Jacoby, A.3    Altman, D.G.4    Gamble, C.5    Williamson, P.R.6
  • 5
    • 33748446657 scopus 로고    scopus 로고
    • Adverse event reporting in publications compared with sponsor database for cancer clinical trials
    • Scharf O, Colevas AD. Adverse event reporting in publications compared with sponsor database for cancer clinical trials. J Clin Oncol 2006; 24: 3933-38.
    • (2006) J Clin Oncol , vol.24 , pp. 3933-3938
    • Scharf, O.1    Colevas, A.D.2
  • 6
    • 83255164859 scopus 로고    scopus 로고
    • Access to data in industry-sponsored trials
    • Lundh A, Krogsboll LT, Gotzsche PC. Access to data in industry-sponsored trials. Lancet 2011; 378: 1995-96.
    • (2011) Lancet , vol.378 , pp. 1995-1996
    • Lundh, A.1    Krogsboll, L.T.2    Gotzsche, P.C.3
  • 8
    • 79952576381 scopus 로고    scopus 로고
    • National Research Council. Panel on Handling Missing Data in Clinical Trials. Committee on National Statistics, Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press
    • National Research Council. The prevention and treatment of missing data in clinical trials. Panel on Handling Missing Data in Clinical Trials. Committee on National Statistics, Division of Behavioral and Social Sciences and Education. Washington, DC: The National Academies Press, 2010.
    • (2010) The Prevention and Treatment of Missing Data in Clinical Trials
  • 10
    • 27744536508 scopus 로고    scopus 로고
    • The activity of French research ethics committees and characteristics of biomedical research protocols involving humans: A retrospective cohort study
    • Decullier E, Lheritier V, Chapuis F. The activity of French research ethics committees and characteristics of biomedical research protocols involving humans: a retrospective cohort study. BMC Med Ethics 2005; 6: E9.
    • (2005) BMC Med Ethics , vol.6
    • Decullier, E.1    Lheritier, V.2    Chapuis, F.3
  • 11
    • 78650404338 scopus 로고    scopus 로고
    • Bridging the gap: Improving clinical development and the regulatory pathways for health products for neglected diseases
    • Bollyky TJ, Cockburn IM, Berndt E. Bridging the gap: improving clinical development and the regulatory pathways for health products for neglected diseases. Clin Trials 2010; 7: 719-34.
    • (2010) Clin Trials , vol.7 , pp. 719-734
    • Bollyky, T.J.1    Cockburn, I.M.2    Berndt, E.3
  • 12
    • 73349130453 scopus 로고    scopus 로고
    • Evaluation of clinical trials by Ethics Committees in Germany: Experience of applicants with the review of requests for opinion of the Ethics Committees - Results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA)
    • Russ H, Busta S, Riedel A, Zoller G, Jost B. Evaluation of clinical trials by Ethics Committees in Germany: experience of applicants with the review of requests for opinion of the Ethics Committees - results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA). Ger Med Sci 2009; 7: Doc07.
    • (2009) Ger Med Sci , vol.7
    • Russ, H.1    Busta, S.2    Riedel, A.3    Zoller, G.4    Jost, B.5
  • 13
    • 84866508138 scopus 로고    scopus 로고
    • Developing a guideline for clinical trial protocol content: Delphi consensus survey
    • Tetzlaff JM, Moher D, Chan A-W. Developing a guideline for clinical trial protocol content: Delphi consensus survey. Trials 2012; 13: 176.
    • (2012) Trials , vol.13 , pp. 176
    • Tetzlaff, J.M.1    Moher, D.2    Chan, A.-W.3
  • 14
    • 84872080748 scopus 로고    scopus 로고
    • SPIRIT 2013 explanation and elaboration: Guidance for protocols of clinical trials
    • Chan A-W, Tetzlaff JM, Gotzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013; 346: e7586.
    • (2013) BMJ , vol.346
    • Chan, A.-W.1    Tetzlaff, J.M.2    Gotzsche, P.C.3
  • 15
    • 84872084158 scopus 로고    scopus 로고
    • Does use of the CONSORT statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review
    • 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.
    • (2012) Syst Rev , vol.1 , pp. 60
    • Turner, L.1    Shamseer, L.2    Altman, D.G.3    Schulz, K.F.4    Moher, D.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.