메뉴 건너뛰기




Volumn 61, Issue SUPPL1, 2014, Pages 18-27

Randomized Controlled Trials and Challenge Trials: Design and Criterion for Validity

Author keywords

Challenge trials; Randomized controlled trials; Study design; Validity; Veterinary

Indexed keywords

ANTIBIOTIC AGENT; VACCINE;

EID: 84902006233     PISSN: 18631959     EISSN: 18632378     Source Type: Journal    
DOI: 10.1111/zph.12126     Document Type: Review
Times cited : (22)

References (45)
  • 1
    • 0018974024 scopus 로고
    • Statistics and ethics in medical research: III How large a sample?
    • Altman, D. G., 1980: Statistics and ethics in medical research: III How large a sample? BMJ 281, 1136-1138.
    • (1980) BMJ , vol.281 , pp. 1136-1138
    • Altman, D.G.1
  • 3
    • 0025759841 scopus 로고
    • Randomisation: essential for reducing bias
    • Altman, D. G., 1991: Randomisation: essential for reducing bias. BMJ 302, 1481-1482.
    • (1991) BMJ , vol.302 , pp. 1481-1482
    • Altman, D.G.1
  • 4
    • 84971580244 scopus 로고
    • Absence of evidence is not evidence of absence
    • Altman, D. G., and J. M. Bland, 1995: Absence of evidence is not evidence of absence. BMJ 311, 485.
    • (1995) BMJ , vol.311 , pp. 485
    • Altman, D.G.1    Bland, J.M.2
  • 5
    • 0025011533 scopus 로고
    • Suspended judgment. Significance tests of covariate imbalance in clinical trials
    • Begg, C. B., 1990: Suspended judgment. Significance tests of covariate imbalance in clinical trials. Control. Clin. Trials 11, 223-225.
    • (1990) Control. Clin. Trials , vol.11 , pp. 223-225
    • Begg, C.B.1
  • 7
    • 1642400145 scopus 로고    scopus 로고
    • CONSORT statement: extension to cluster randomised trials
    • Campbell, M. K., D. R. Elbourne, and D. G. Altman, 2004: CONSORT statement: extension to cluster randomised trials. BMJ 328, 702-708.
    • (2004) BMJ , vol.328 , pp. 702-708
    • Campbell, M.K.1    Elbourne, D.R.2    Altman, D.G.3
  • 8
    • 0036853058 scopus 로고    scopus 로고
    • Overview of research designs
    • Clancy, M. J., 2002: Overview of research designs. Emerg. Med. J. 19, 546-549.
    • (2002) Emerg. Med. J. , vol.19 , pp. 546-549
    • Clancy, M.J.1
  • 10
    • 84902009807 scopus 로고    scopus 로고
    • CONSORT, CONSORT statement. Available at (Accessed on 09 April 2013)
    • CONSORT, 2010: CONSORT statement. Available at: http://www.consort-statement.org/ (Accessed on 09 April 2013).
    • (2010)
  • 15
    • 0023185342 scopus 로고
    • Equipoise and the ethics of clinical research
    • Freedman, B., 1987: Equipoise and the ethics of clinical research. N. Engl. J. Med. 317, 141-145.
    • (1987) N. Engl. J. Med. , vol.317 , pp. 141-145
    • Freedman, B.1
  • 16
    • 84867912727 scopus 로고    scopus 로고
    • Blinding terminology used in reports of randomized controlled trials involving dogs and cats
    • Giuffrida, M. A., K. A. Agnello, and D. C. Brown, 2012: Blinding terminology used in reports of randomized controlled trials involving dogs and cats. J. Am. Vet. Med. Assoc. 241, 1221-1226.
    • (2012) J. Am. Vet. Med. Assoc. , vol.241 , pp. 1221-1226
    • Giuffrida, M.A.1    Agnello, K.A.2    Brown, D.C.3
  • 17
    • 33748646566 scopus 로고    scopus 로고
    • Clinical trial design issues: at least 10 things you should look for in clinical trials
    • Glasser, S. P., and G. Howard, 2006: Clinical trial design issues: at least 10 things you should look for in clinical trials. J. Clin. Pharmacol. 46, 1106-1115.
    • (2006) J. Clin. Pharmacol. , vol.46 , pp. 1106-1115
    • Glasser, S.P.1    Howard, G.2
  • 18
    • 0018398041 scopus 로고
    • The two-period cross-over clinical trial
    • Hills, M., and P. Armitage, 1979: The two-period cross-over clinical trial. Br. J. Clin. Pharmacol. 8, 7-20.
    • (1979) Br. J. Clin. Pharmacol. , vol.8 , pp. 7-20
    • Hills, M.1    Armitage, P.2
  • 19
    • 0036374476 scopus 로고    scopus 로고
    • Experimental design and statistics in biomedical research practical aspects of experimental design in animal research
    • Johnson, P. D., and D. G. Besselsen, 2002: Experimental design and statistics in biomedical research practical aspects of experimental design in animal research. ILAR J. 43, 202-206.
    • (2002) ILAR J. , vol.43 , pp. 202-206
    • Johnson, P.D.1    Besselsen, D.G.2
  • 20
    • 0035822324 scopus 로고    scopus 로고
    • Systematic reviews in health care: assessing the quality of controlled clinical trials
    • Juni, P., D. G. Altman, and M. Egger, 2001: Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ 323, 42-46.
    • (2001) BMJ , vol.323 , pp. 42-46
    • Juni, P.1    Altman, D.G.2    Egger, M.3
  • 21
    • 21244496815 scopus 로고    scopus 로고
    • Are clinical trials in rheumatoid arthritis generalizable to routine practice? A re-evaluation of trial entry criteria
    • Kingsley, G. H., B. Khoshaba, C. M. Smith, E. H. Choy, and D. L. Scott, 2005: Are clinical trials in rheumatoid arthritis generalizable to routine practice? A re-evaluation of trial entry criteria. Rheumatology (Oxford) 44, 629-632.
    • (2005) Rheumatology (Oxford) , vol.44 , pp. 629-632
    • Kingsley, G.H.1    Khoshaba, B.2    Smith, C.M.3    Choy, E.H.4    Scott, D.L.5
  • 22
    • 0035808035 scopus 로고    scopus 로고
    • Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses
    • Kjaergard, L. L., J. Villumsen, and C. Gluud, 2001: Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses. Ann. Intern. Med. 135, 982-989.
    • (2001) Ann. Intern. Med. , vol.135 , pp. 982-989
    • Kjaergard, L.L.1    Villumsen, J.2    Gluud, C.3
  • 23
    • 0034061095 scopus 로고    scopus 로고
    • Statistical considerations in the intent-to-treat principle
    • Lachin, J. L., 2000: Statistical considerations in the intent-to-treat principle. Control. Clin. Trials 21, 167-189.
    • (2000) Control. Clin. Trials , vol.21 , pp. 167-189
    • Lachin, J.L.1
  • 24
    • 0028792136 scopus 로고
    • Equipoise and the ethics of randomization
    • Lilford, R. J., and J. Jackson, 1995: Equipoise and the ethics of randomization. J. R. Soc. Med. 88, 552-559.
    • (1995) J. R. Soc. Med. , vol.88 , pp. 552-559
    • Lilford, R.J.1    Jackson, J.2
  • 25
    • 0028509653 scopus 로고
    • Clinical trial design: veterinary perspectives
    • Lund, E. M., K. M. James, and J. D. Neaton, 1994: Clinical trial design: veterinary perspectives. J. Vet. Intern. Med. 8, 317-322.
    • (1994) J. Vet. Intern. Med. , vol.8 , pp. 317-322
    • Lund, E.M.1    James, K.M.2    Neaton, J.D.3
  • 26
    • 0035906308 scopus 로고    scopus 로고
    • The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials
    • Moher, D., K. F. Schulz, and D. Altman, 2001: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 285, 1987-1991.
    • (2001) JAMA , vol.285 , pp. 1987-1991
    • Moher, D.1    Schulz, K.F.2    Altman, D.3
  • 28
    • 84872006253 scopus 로고    scopus 로고
    • Rerandomization to improve covariate balance in experiments
    • Morgan, K. L., and D. B. Rubin, 2012: Rerandomization to improve covariate balance in experiments. Ann. Stats. 40, 1263-1282.
    • (2012) Ann. Stats. , vol.40 , pp. 1263-1282
    • Morgan, K.L.1    Rubin, D.B.2
  • 33
    • 33846216344 scopus 로고    scopus 로고
    • Methodological quality assessment of review articles evaluating interventions to improve microbial food safety
    • Sargeant, J. M., M. E. Torrence, A. Rajic, A. M. O'Connor, and J. Williams, 2006: Methodological quality assessment of review articles evaluating interventions to improve microbial food safety. Foodborne Pathog. Dis. 3, 447-456.
    • (2006) Foodborne Pathog. Dis. , vol.3 , pp. 447-456
    • Sargeant, J.M.1    Torrence, M.E.2    Rajic, A.3    O'Connor, A.M.4    Williams, J.5
  • 35
    • 70350097938 scopus 로고    scopus 로고
    • Quality of reporting in clinical trials of preharvest food safety interventions and associations with treatment effect
    • Sargeant, J. M., J. Saint-Onge, J. Valcour, A. Thompson, R. Elgie, K. Snedeker, and P. Marcynuk, 2009b: Quality of reporting in clinical trials of preharvest food safety interventions and associations with treatment effect. Foodborne Pathog. Dis. 6, 989-999.
    • (2009) Foodborne Pathog. Dis. , vol.6 , pp. 989-999
    • Sargeant, J.M.1    Saint-Onge, J.2    Valcour, J.3    Thompson, A.4    Elgie, R.5    Snedeker, K.6    Marcynuk, P.7
  • 38
    • 0028849245 scopus 로고
    • Subverting randomization in controlled trials
    • Schulz, K. F., 1995: Subverting randomization in controlled trials. JAMA 274, 1456-1458.
    • (1995) JAMA , vol.274 , pp. 1456-1458
    • Schulz, K.F.1
  • 39
    • 0037045587 scopus 로고    scopus 로고
    • Generation of allocation sequences in randomised trials: chance, not choice
    • Schulz, K. F., and D. A. Grimes, 2002: Generation of allocation sequences in randomised trials: chance, not choice. Lancet 359, 515-519.
    • (2002) Lancet , vol.359 , pp. 515-519
    • Schulz, K.F.1    Grimes, D.A.2
  • 40
    • 17044362679 scopus 로고    scopus 로고
    • Sample size calculations in randomised trials: mandatory and mystical
    • Schulz, K. F., and D. A. Grimes, 2005: Sample size calculations in randomised trials: mandatory and mystical. Lancet 365, 1348-1353.
    • (2005) Lancet , vol.365 , pp. 1348-1353
    • Schulz, K.F.1    Grimes, D.A.2
  • 41
    • 77953685708 scopus 로고    scopus 로고
    • CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomized trials
    • for the CONSORT group
    • Schulz, K. F., D. G. Alman, D. Moher, and for the CONSORT group, 2010: CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomized trials. J. Clin. Epidemiol. 63, 834-840.
    • (2010) J. Clin. Epidemiol. , vol.63 , pp. 834-840
    • Schulz, K.F.1    Alman, D.G.2    Moher, D.3
  • 43
    • 0036158453 scopus 로고    scopus 로고
    • In quest of the holy grail: efficacy versus effectiveness in rheumatoid arthritis
    • Suarez-Almazor, M. E., 2002: In quest of the holy grail: efficacy versus effectiveness in rheumatoid arthritis. J. Rheumatol. 29, 209-211.
    • (2002) J. Rheumatol. , vol.29 , pp. 209-211
    • Suarez-Almazor, M.E.1
  • 44
    • 0034706254 scopus 로고    scopus 로고
    • For and against - Clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial
    • Weijer, C., S. H. Shapiro, K. C. Glass, and M. W. Enkin, 2000: For and against - Clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial. Br. Med. J. 321, 756-758.
    • (2000) Br. Med. J. , vol.321 , pp. 756-758
    • Weijer, C.1    Shapiro, S.H.2    Glass, K.C.3    Enkin, M.W.4
  • 45
    • 7044227565 scopus 로고    scopus 로고
    • Why results of clinical trials and observational studies of anti-TNF therapy differ: methodological and interpretive issues
    • Wolfe, F., 2005: Why results of clinical trials and observational studies of anti-TNF therapy differ: methodological and interpretive issues. Ann. Rheum. Dis. 63, ii13-ii17.
    • (2005) Ann. Rheum. Dis. , vol.63
    • Wolfe, F.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.