메뉴 건너뛰기




Volumn 43, Issue , 2015, Pages 155-163

Blinding in pharmaceutical clinical trials: An overview of points to consider

Author keywords

Bias; Blinding; Double blind; Randomized controlled trial

Indexed keywords

ARTICLE; CLINICAL RESEARCH; DOUBLE BLIND PROCEDURE; HUMAN; INFORMATION PROCESSING; INTERPERSONAL COMMUNICATION; NOMENCLATURE; OPEN STUDY; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; QUALITY CONTROL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH SUBJECT; SELECTION BIAS; SINGLE BLIND PROCEDURE; STAFF; STATISTICAL ANALYSIS; TRIPLE BLIND PROCEDURE; METHODOLOGY; PATIENT SAFETY; PROCEDURES; STANDARDS;

EID: 84930947340     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2015.06.002     Document Type: Article
Times cited : (8)

References (23)
  • 1
    • 84873069654 scopus 로고    scopus 로고
    • Available at:
    • ICH E9 Statistical principles for clinical trials Available at:. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf.
    • Statistical principles for clinical trials
  • 2
    • 79551561460 scopus 로고    scopus 로고
    • The blind leading the blind: use and misuse of blinding in randomized controlled trials
    • Miller L.E., Stewart M.E. The blind leading the blind: use and misuse of blinding in randomized controlled trials. Contemp. Clin. Trials 2011, 32:240-243.
    • (2011) Contemp. Clin. Trials , vol.32 , pp. 240-243
    • Miller, L.E.1    Stewart, M.E.2
  • 3
    • 0037022272 scopus 로고    scopus 로고
    • The landscape and lexicon of blinding in randomized trials
    • Schulz K.F., Chalmers I., Altman D.G. The landscape and lexicon of blinding in randomized trials. Ann. Intern. Med. 2002, 136:254-259.
    • (2002) Ann. Intern. Med. , vol.136 , pp. 254-259
    • Schulz, K.F.1    Chalmers, I.2    Altman, D.G.3
  • 4
    • 0037160763 scopus 로고    scopus 로고
    • Blinding in randomised trials: hiding who got what
    • Schultz K.F., Grimes D.A. Blinding in randomised trials: hiding who got what. Lancet 2002, 359:696-700.
    • (2002) Lancet , vol.359 , pp. 696-700
    • Schultz, K.F.1    Grimes, D.A.2
  • 6
    • 84930955470 scopus 로고    scopus 로고
    • Available at:, (Accessed 28th May, 2015)
    • Tafinlar US label Available at:, (Accessed 28th May, 2015). http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806s000lbl.pdf.
  • 7
    • 0003663972 scopus 로고    scopus 로고
    • Available at:
    • ICH E6 Guideline for good clinical practice Available at:. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf.
    • Guideline for good clinical practice
  • 9
    • 84930955471 scopus 로고    scopus 로고
    • CONSORT statement http://www.consort-statement.org/Media/Default/Downloads/CONSORT%202010%20Statement/CONSORT%202010%20Explanation%20and%20Elaboration%20(BMJ).pdf.
  • 10
    • 67649383249 scopus 로고    scopus 로고
    • Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs
    • Pogue J., Walter S.D., Yusuf S. Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs. Clin. Trials 2009, 6:239-251.
    • (2009) Clin. Trials , vol.6 , pp. 239-251
    • Pogue, J.1    Walter, S.D.2    Yusuf, S.3
  • 11
    • 80051550048 scopus 로고    scopus 로고
    • Blinded independent central review of progression in cancer clinical trials: results from a meta-analysis
    • Amit O., Mannino F., Stone A.M., Bushnell W., Denne J., Helterbrand J., Burger H.U. Blinded independent central review of progression in cancer clinical trials: results from a meta-analysis. Eur. J. Cancer 2011, 47:1772-1778.
    • (2011) Eur. J. Cancer , vol.47 , pp. 1772-1778
    • Amit, O.1    Mannino, F.2    Stone, A.M.3    Bushnell, W.4    Denne, J.5    Helterbrand, J.6    Burger, H.U.7
  • 13
    • 84872021208 scopus 로고    scopus 로고
    • Adaptive increase in sample size when interim results are promising: a practical guide with examples
    • Mehta C.R., Pocock S.J. Adaptive increase in sample size when interim results are promising: a practical guide with examples. Stat. Med. 2010, 10.1002/sim.4012.
    • (2010) Stat. Med.
    • Mehta, C.R.1    Pocock, S.J.2
  • 14
    • 84930955472 scopus 로고    scopus 로고
    • FDA Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pd.
  • 17
    • 77952569050 scopus 로고    scopus 로고
    • Blinding assessment in clinical trials: a review of statistical methods and a proposal of blinding assessment protocol
    • Bang H., Flaherty S., Kolahi J., Park J. Blinding assessment in clinical trials: a review of statistical methods and a proposal of blinding assessment protocol. Clin. Res. Regul. Aff. 2010, 27(2):42-51.
    • (2010) Clin. Res. Regul. Aff. , vol.27 , Issue.2 , pp. 42-51
    • Bang, H.1    Flaherty, S.2    Kolahi, J.3    Park, J.4
  • 18
    • 84901033721 scopus 로고    scopus 로고
    • Accounting for perception, placebo and unmasking effects in estimating treatment effects in randomized clinical trials
    • Jamshidian F., Hubbard A.E., Jewell N.P. Accounting for perception, placebo and unmasking effects in estimating treatment effects in randomized clinical trials. Stat. Methods Med. Res. 2014, 23(3):293-307.
    • (2014) Stat. Methods Med. Res. , vol.23 , Issue.3 , pp. 293-307
    • Jamshidian, F.1    Hubbard, A.E.2    Jewell, N.P.3
  • 19
    • 1542291119 scopus 로고    scopus 로고
    • Assessment of blinding in clinical trials
    • Bang H., Ni L., Davis C.E. Assessment of blinding in clinical trials. Control. Clin. Trials 2004, 25:143-156.
    • (2004) Control. Clin. Trials , vol.25 , pp. 143-156
    • Bang, H.1    Ni, L.2    Davis, C.E.3
  • 20
  • 21
    • 77950187973 scopus 로고    scopus 로고
    • CONSORT 2010 changes and testing blindness in RCTs
    • Schulz K.F., Altman D.G., Moher D., Fergusson D. CONSORT 2010 changes and testing blindness in RCTs. Lancet 2010, 375:1144-1146.
    • (2010) Lancet , vol.375 , pp. 1144-1146
    • Schulz, K.F.1    Altman, D.G.2    Moher, D.3    Fergusson, D.4
  • 22
    • 79952540438 scopus 로고    scopus 로고
    • CONSORT 2010 and controversies regarding assessment of blindness in RCTs
    • Kolahi J., Bang H., Park J.J., Desbiens N.A. CONSORT 2010 and controversies regarding assessment of blindness in RCTs. Dent. Hypotheses 2010, 2:99-105.
    • (2010) Dent. Hypotheses , vol.2 , pp. 99-105
    • Kolahi, J.1    Bang, H.2    Park, J.J.3    Desbiens, N.A.4
  • 23
    • 79952550150 scopus 로고    scopus 로고
    • Assessing blinding in randomized controlled trials of acupuncture: challenges and recommendations
    • Hopton A.K., MacPherson H. Assessing blinding in randomized controlled trials of acupuncture: challenges and recommendations. Chin. J. Integr. Med. 2011, 17(3):173-176.
    • (2011) Chin. J. Integr. Med. , vol.17 , Issue.3 , pp. 173-176
    • Hopton, A.K.1    MacPherson, H.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.