메뉴 건너뛰기




Volumn 21, Issue 5, 2008, Pages 433-439

Noninferiority and equivalence designs: Issues and implications for mental health research

Author keywords

[No Author keywords available]

Indexed keywords

HUMANS; MENTAL HEALTH; RESEARCH; RESEARCH DESIGN;

EID: 61749090504     PISSN: 08949867     EISSN: 15736598     Source Type: Journal    
DOI: 10.1002/jts.20367     Document Type: Conference Paper
Times cited : (153)

References (30)
  • 1
    • 4143096170 scopus 로고    scopus 로고
    • Current issues in clinical equivalence trials
    • Blackwelder, W. C. (2004). Current issues in clinical equivalence trials. Journal of Dental Research, 83(Special Issue C), C113-C115.
    • (2004) Journal of Dental Research , vol.83 , Issue.SPEC. ISSUE C
    • Blackwelder, W.C.1
  • 2
    • 0020308864 scopus 로고
    • Proving the null hypothesis in clinical trials
    • Blackwelder, W. C. (1982). "Proving the null hypothesis" in clinical trials. Controlled Clinical Trials, 3, 345-353.
    • (1982) Controlled Clinical Trials , vol.3 , pp. 345-353
    • Blackwelder, W.C.1
  • 3
    • 11344257356 scopus 로고    scopus 로고
    • A comparison of intent-to-treat and per-protocol results in antibiotic non-inferiority trials
    • Brittain, E., & Lin, D. (2005). A comparison of intent-to-treat and per-protocol results in antibiotic non-inferiority trials. Statistics in Medicine, 24, 1-10.
    • (2005) Statistics in Medicine , vol.24 , pp. 1-10
    • Brittain, E.1    Lin, D.2
  • 5
    • 0017643592 scopus 로고
    • Significance testing to establish equivalence between treatments with special reference to data in the form of 2 × 2 tables
    • Dunnett, C. W., & Gent, M. (1977). Significance testing to establish equivalence between treatments with special reference to data in the form of 2 × 2 tables. Biometrics, 33, 593-602.
    • (1977) Biometrics , vol.33 , pp. 593-602
    • Dunnett, C.W.1    Gent, M.2
  • 6
    • 0025051476 scopus 로고
    • Planning and monitoring of equivalence studies
    • Durrleman, S., & Simon, R. (1990). Planning and monitoring of equivalence studies. Biometrics, 46, 329-336.
    • (1990) Biometrics , vol.46 , pp. 329-336
    • Durrleman, S.1    Simon, R.2
  • 7
    • 33846494292 scopus 로고    scopus 로고
    • A randomized, controlled trial with 6-month follow-up of repetitive transcranial magnetic stimulation and electroconvulsive therapy for severe depression
    • Eranti, S., Mogg, A., Pluck, G., Landau, S., Purvis, R., Brown, R. G., et al., (2007). A randomized, controlled trial with 6-month follow-up of repetitive transcranial magnetic stimulation and electroconvulsive therapy for severe depression. American Journal of Psychiatry, 164, 73-81.
    • (2007) American Journal of Psychiatry , vol.164 , pp. 73-81
    • Eranti, S.1    Mogg, A.2    Pluck, G.3    Landau, S.4    Purvis, R.5    Brown, R.G.6
  • 9
    • 0037445366 scopus 로고    scopus 로고
    • Therapeutic equivalence: Fallacies and falsification
    • Garrett, A. D. (2003). Therapeutic equivalence: Fallacies and falsification. Statistics in Medicine, 22, 741-762.
    • (2003) Statistics in Medicine , vol.22 , pp. 741-762
    • Garrett, A.D.1
  • 10
    • 0034595229 scopus 로고    scopus 로고
    • Claims of equivalence in medical research: Are they supported by the evidence?
    • Greene, W. L., Concato, J., & Feinstein, A. R (2000). Claims of equivalence in medical research: Are they supported by the evidence? Annals of Internal Medicine, 132, 715-722.
    • (2000) Annals of Internal Medicine , vol.132 , pp. 715-722
    • Greene, W.L.1    Concato, J.2    Feinstein, A.R.3
  • 11
    • 39049155459 scopus 로고    scopus 로고
    • Hermens, M., van Hout, H. P. J., Terluin, B., J Adèr, H., Penninx, B. W. J. H., van Marwijk,. H. W. J., et al. (2007). Clinical effectiveness of usual care with or without antidepressant medication for primary care patients with minor or mild-major depression: A randomized equivalence trial. Biomed Central Medicine, 5, 36. doi: 10.1186/1741-7015-5-36.
    • Hermens, M., van Hout, H. P. J., Terluin, B., J Adèr, H., Penninx, B. W. J. H., van Marwijk,. H. W. J., et al. (2007). Clinical effectiveness of usual care with or without antidepressant medication for primary care patients with minor or mild-major depression: A randomized equivalence trial. Biomed Central Medicine, 5, 36. doi: 10.1186/1741-7015-5-36.
  • 12
    • 0032694404 scopus 로고    scopus 로고
    • Design issues in noninferiority/ equivalence trials
    • Hwang, I. K., & Morikawa, T. (1999). Design issues in noninferiority/ equivalence trials. Drug Information Journal, 33, 1205-1218.
    • (1999) Drug Information Journal , vol.33 , pp. 1205-1218
    • Hwang, I.K.1    Morikawa, T.2
  • 13
    • 61849094857 scopus 로고    scopus 로고
    • International Conference on Harmonisation. (1998): ICH Topic E9: Statistical principles for clinical trials. Retrieved March 8, 2006, from http://www.emea.europa.eu/pdfs/human/ich/036396en.pdf
    • International Conference on Harmonisation. (1998): ICH Topic E9: Statistical principles for clinical trials. Retrieved March 8, 2006, from http://www.emea.europa.eu/pdfs/human/ich/036396en.pdf
  • 14
    • 61849174326 scopus 로고    scopus 로고
    • International Conference on Harmonisation. (2001). ICH Topic E10: Choice of control group and related issues in clinical trials. Retrieved on March 8, 2006, from http://www.emea.europa.cu/pdfs/hwnan/ich/036496en.pdf
    • International Conference on Harmonisation. (2001). ICH Topic E10: Choice of control group and related issues in clinical trials. Retrieved on March 8, 2006, from http://www.emea.europa.cu/pdfs/hwnan/ich/036496en.pdf
  • 16
    • 0029987569 scopus 로고    scopus 로고
    • Trials to assess equivalence: The importance of rigorous methods
    • Jones, B., Jarvis, R, Lewis, J. A., & Ebbutt, A. F. (1996). Trials to assess equivalence: The importance of rigorous methods. British Medical Journal, 313, 36-39.
    • (1996) British Medical Journal , vol.313 , pp. 36-39
    • Jones, B.1    Jarvis, R.2    Lewis, J.A.3    Ebbutt, A.F.4
  • 17
    • 4344584922 scopus 로고    scopus 로고
    • Tutorial in biostatistics: Sample sizes for clinical trials with normal data
    • Julious, S. A. (2004). Tutorial in biostatistics: Sample sizes for clinical trials with normal data. Statistics in Medicine, 23, 1921-1986.
    • (2004) Statistics in Medicine , vol.23 , pp. 1921-1986
    • Julious, S.A.1
  • 19
    • 0029164844 scopus 로고
    • Biostatistical methodology in clinical trials - A European guideline
    • Lewis, J. A., Jones, D. R., & Rohmel, J. (1995). Biostatistical methodology in clinical trials - A European guideline. Statistics in Medicine, 14, 1655-1657.
    • (1995) Statistics in Medicine , vol.14 , pp. 1655-1657
    • Lewis, J.A.1    Jones, D.R.2    Rohmel, J.3
  • 20
    • 33750590360 scopus 로고    scopus 로고
    • Telephone administered cognitive behaviour therapy for treatment of obsessive compulsive disorder: Randomised controlled non-inferiority trial
    • doi:10.1136/ bmj.38940.355602.80
    • Lovell, K., Cox, C., Haddock, G., Jones, C., Raines, D., Garvey, R., et al. (2006). Telephone administered cognitive behaviour therapy for treatment of obsessive compulsive disorder: Randomised controlled non-inferiority trial. British Medical Journal, 333, 883. doi:10.1136/ bmj.38940.355602.80.
    • (2006) British Medical Journal , vol.333 , pp. 883
    • Lovell, K.1    Cox, C.2    Haddock, G.3    Jones, C.4    Raines, D.5    Garvey, R.6
  • 21
    • 0018103242 scopus 로고
    • Sample size requirements for evaluating a conservative therapy
    • Makuch, R. W., & Simon, R. M. (1978). Sample size requirements for evaluating a conservative therapy, Cancer Treatment Reports, 62, 1037-1040.
    • (1978) Cancer Treatment Reports , vol.62 , pp. 1037-1040
    • Makuch, R.W.1    Simon, R.M.2
  • 23
    • 0028803916 scopus 로고
    • Conventional null hypothesis testing in active control equivalence studies
    • Ng, T. (1995). Conventional null hypothesis testing in active control equivalence studies. Controlled Clinical Trials, 16, 356-358.
    • (1995) Controlled Clinical Trials , vol.16 , pp. 356-358
    • Ng, T.1
  • 24
    • 34250894450 scopus 로고    scopus 로고
    • Is telepsychiatry equivalent to face-to-face psychiatry? Results from a randomized controlled equivalence trial
    • O'Reilly, R., Bishop J., Maddox, J., Hutchinson, E, Fismin, M., & Takhar, J. (2007). Is telepsychiatry equivalent to face-to-face psychiatry? Results from a randomized controlled equivalence trial. Psychiatric Services, 58, 836-843.
    • (2007) Psychiatric Services , vol.58 , pp. 836-843
    • O'Reilly, R.1    Bishop, J.2    Maddox, J.3    Hutchinson, E.4    Fismin, M.5    Takhar, J.6
  • 28
    • 0034687072 scopus 로고    scopus 로고
    • Placebo-controlled trials and active control trials in the evaluation of new treatments. Part 1: Ethical and scientific issues
    • Temple, R., & Ellenberg, S. S. (2000). Placebo-controlled trials and active control trials in the evaluation of new treatments. Part 1: Ethical and scientific issues. Annals of Internal Medicine, 133, 455-463.
    • (2000) Annals of Internal Medicine , vol.133 , pp. 455-463
    • Temple, R.1    Ellenberg, S.S.2
  • 29
    • 0035006807 scopus 로고    scopus 로고
    • Clinician-Administered PTSD Scale: A review of the first ten years of research
    • Weathers, F. W., Keane, T. M., & Davidson, J. R. T. (2001). Clinician-Administered PTSD Scale: A review of the first ten years of research. Depression and Anxiety, 13, 132-156.
    • (2001) Depression and Anxiety , vol.13 , pp. 132-156
    • Weathers, F.W.1    Keane, T.M.2    Davidson, J.R.T.3
  • 30
    • 0036169283 scopus 로고    scopus 로고
    • Choosing an equivalence limit for noninferiority and equivalence studies
    • Wiens, B. L. (2002). Choosing an equivalence limit for noninferiority and equivalence studies. Controlled Clinical Trials, 23, 2-14.
    • (2002) Controlled Clinical Trials , vol.23 , pp. 2-14
    • Wiens, B.L.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.