메뉴 건너뛰기




Volumn 112, Issue SUPPL. 1, 1999, Pages 21-27

En busca de la evidencia perdida. Propuestas para incrementar la transparencia de los ensayos clínicos

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIAL; EVIDENCE BASED MEDICINE; HUMAN; INTERNATIONAL COOPERATION; LEGAL ASPECT; MANAGEMENT; METHODOLOGY; PROFESSIONAL STANDARD; PUBLISHING; RESEARCH; REVIEW; STANDARD;

EID: 0033253035     PISSN: 00257753     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (3)

References (58)
  • 6
    • 0025100849 scopus 로고
    • The existence of publication bias and risk factors for its occurrence
    • Dickersin K. The existence of publication bias and risk factors for its occurrence. JAMA 1990; 263: 1.885-1.889.
    • (1990) JAMA , vol.263 , pp. 1885-1889
    • Dickersin, K.1
  • 7
    • 0031441790 scopus 로고    scopus 로고
    • The relationship between study design, results, and reporting of randomized clinical trials HIV infection
    • Ioannidis JP, Cappelleri JC, Sacks HS, Lau J. The relationship between study design, results, and reporting of randomized clinical trials HIV infection. Control Clin Trials 1997; 18: 431-444.
    • (1997) Control Clin Trials , vol.18 , pp. 431-444
    • Ioannidis, J.P.1    Cappelleri, J.C.2    Sacks, H.S.3    Lau, J.4
  • 8
    • 0030923529 scopus 로고    scopus 로고
    • Publication bias: Evidence of delayed publication in a cohort study of clinical research projects
    • Stern JM, Simes RJ. Publication bias: evidence of delayed publication in a cohort study of clinical research projects. Br Med J 1997; 315: 640-645.
    • (1997) Br Med J , vol.315 , pp. 640-645
    • Stern, J.M.1    Simes, R.J.2
  • 10
    • 0028440677 scopus 로고
    • Positive-outcome bias: Comparison of emergency medicine and general medicine literatures
    • Moscati R, Jehle D, Ellis D, Fiorello A, Landi M. Positive-outcome bias: comparison of emergency medicine and general medicine literatures. Acad Emerg Med 1994; 1: 267-271.
    • (1994) Acad Emerg Med , vol.1 , pp. 267-271
    • Moscati, R.1    Jehle, D.2    Ellis, D.3    Fiorello, A.4    Landi, M.5
  • 11
    • 0027925222 scopus 로고
    • NIH clinical trials and publication bias
    • Apr 28; Doc No. 50
    • Dickersin K, Min YI. NIH clinical trials and publication bias. Online J Curr Clin Trials 1993; Apr 28; Doc No. 50.
    • (1993) Online J Curr Clin Trials
    • Dickersin, K.1    Min, Y.I.2
  • 14
    • 0025190248 scopus 로고
    • Minimizing the three stages of publications bias
    • Chalmers TC, Frack CS, Reitman D, Minimizing the three stages of publications bias JAMA 1990; 263: 1.392-1.395.
    • (1990) JAMA , vol.263 , pp. 1392-1395
    • Chalmers, T.C.1    Frack, C.S.2    Reitman, D.3
  • 15
    • 0000385491 scopus 로고
    • Publication bias: A problem in interpreting medical data
    • Begg CB, Berlin JA. Publication bias: a problem in interpreting medical data. J Roy Stat Soc A 1988; 151: 419-463.
    • (1988) J Roy Stat Soc A , vol.151 , pp. 419-463
    • Begg, C.B.1    Berlin, J.A.2
  • 16
    • 0024578397 scopus 로고
    • Publication bias and dissemination of clinical research
    • Begg CB, Berlin JA. Publication bias and dissemination of clinical research. J Natl Cancer Inst 1989; 81: 107-115.
    • (1989) J Natl Cancer Inst , vol.81 , pp. 107-115
    • Begg, C.B.1    Berlin, J.A.2
  • 17
    • 0000544148 scopus 로고
    • An assessment of publication bias using a sample of published clinical trials
    • Berlin JA, Begg CB, Louis TA. An assessment of publication bias using a sample of published clinical trials. J Am Stat Assoc 1989; 84: 381-392.
    • (1989) J Am Stat Assoc , vol.84 , pp. 381-392
    • Berlin, J.A.1    Begg, C.B.2    Louis, T.A.3
  • 18
    • 0023110123 scopus 로고
    • Confronting publication bias: A cohort design for meta-analysis
    • Simes RJ. Confronting publication bias: a cohort design for meta-analysis. Stat Med 1987; 6: 11-29.
    • (1987) Stat Med , vol.6 , pp. 11-29
    • Simes, R.J.1
  • 19
    • 0023008125 scopus 로고
    • Publication bias: The case for an international registry of clinical trials
    • Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncol 1986; 4: 1.529-1.541.
    • (1986) J Clin Oncol , vol.4 , pp. 1529-1541
    • Simes, R.J.1
  • 21
    • 0026542772 scopus 로고
    • Factors influencing publication of research results
    • Dickersin K, Min YI, Meinert CL. Factors influencing publication of research results. JAMA 1992; 267: 374-378.
    • (1992) JAMA , vol.267 , pp. 374-378
    • Dickersin, K.1    Min, Y.I.2    Meinert, C.L.3
  • 22
    • 0027925222 scopus 로고
    • NIH clinical trials and publication bias
    • Apr 28; Doc No. 50
    • Dickersin K, Min YI. NIH clinical trials and publication bias. Online J Curr Clin Trials 1993 Apr 28; Doc No. 50.
    • (1993) Online J Curr Clin Trials
    • Dickersin, K.1    Min, Y.I.2
  • 23
    • 0041006721 scopus 로고
    • National Institute of Health inventory of clinical trials: fiscal year
    • National Institute of Health inventory of clinical trials: fiscal year 1979.
    • (1979)
  • 24
    • 0023945443 scopus 로고
    • Toward prospective registration of clinical trials
    • Meinert CL. Toward prospective registration of clinical trials. Control Clin Trials 1988; 9: 1-5.
    • (1988) Control Clin Trials , vol.9 , pp. 1-5
    • Meinert, C.L.1
  • 25
    • 0023946910 scopus 로고
    • Report from the panel on the case for registers of clinical trials at the eighth annual meeting of the society for clinical trials
    • Dickersin K. Report from the panel on the case for registers of clinical trials at the eighth Annual Meeting of the Society for Clinical Trials. Control Clin Trials 1988; 9: 76-81.
    • (1988) Control Clin Trials , vol.9 , pp. 76-81
    • Dickersin, K.1
  • 26
    • 0026561593 scopus 로고
    • Why register clinical trials?
    • Dickersin K. Why register clinical trials? Control Clin Trials 1992; 13: 170-177.
    • (1992) Control Clin Trials , vol.13 , pp. 170-177
    • Dickersin, K.1
  • 27
    • 0041006720 scopus 로고    scopus 로고
    • Real Decreto 561/1993, de 16 de abril, por el que se establecen los requisitos para la realización de ensayos cllnicos con medicamentos
    • Real Decreto 561/1993, de 16 de abril, por el que se establecen los requisitos para la realización de ensayos cllnicos con medicamentos.
  • 28
    • 0029889927 scopus 로고    scopus 로고
    • Assessing the quality of randomized controlled trials: Current issues and future directions
    • Moher D, Jadad AR, Tugwell P, Assessing the quality of randomized controlled trials: current issues and future directions. Int J Technol Assess Health Care 1996; 12: 195-208.
    • (1996) Int J Technol Assess Health Care , vol.12 , pp. 195-208
    • Moher, D.1    Jadad, A.R.2    Tugwell, P.3
  • 29
    • 0022480004 scopus 로고
    • A quality assessment of randomized control trials of primary treatment of breast cancer
    • Liberati A, Himel HN, Chalmers TC. A quality assessment of randomized control trials of primary treatment of breast cancer. J Clin Oncol 1986; 4: 942-951.
    • (1986) J Clin Oncol , vol.4 , pp. 942-951
    • Liberati, A.1    Himel, H.N.2    Chalmers, T.C.3
  • 30
    • 0022007270 scopus 로고
    • Methodologic guidelines for reports of clinical trials
    • Simon R, Wittes RE. Methodologic guidelines for reports of clinical trials. Cancer Treatment Reports 1985; 69: 1-3.
    • (1985) Cancer Treatment Reports , vol.69 , pp. 1-3
    • Simon, R.1    Wittes, R.E.2
  • 31
    • 0024654793 scopus 로고
    • Reporting controlled trials
    • Grant A. Reporting controlled trials. Br J Obstet Gynaecol 1989; 96: 397-400.
    • (1989) Br J Obstet Gynaecol , vol.96 , pp. 397-400
    • Grant, A.1
  • 32
    • 0020709691 scopus 로고
    • Guidelines for publishing papers on cancer clinical trials: Responsabilities of editors and authors
    • Zelen M. Guidelines for publishing papers on cancer clinical trials: responsabilities of editors and authors. J Clin Oncol 1983; 1: 154-169.
    • (1983) J Clin Oncol , vol.1 , pp. 154-169
    • Zelen, M.1
  • 33
    • 0019135810 scopus 로고
    • Reporting standards and research strategies for controlled trials
    • Mosteller F, Gilbert JP, McPeek B. Reporting standards and research strategies for controlled trials. Control Clin Trials 1980; 1: 37-58.
    • (1980) Control Clin Trials , vol.1 , pp. 37-58
    • Mosteller, F.1    Gilbert, J.P.2    McPeek, B.3
  • 34
    • 0022580818 scopus 로고
    • Use of checklists in assessing the statistical content of medical studies
    • Gardner MJ, Machin D, Campdell MJ. Use of checklists in assessing the statistical content of medical studies. Br Med J 1986; 292: 810-812.
    • (1986) Br Med J , vol.292 , pp. 810-812
    • Gardner, M.J.1    Machin, D.2    Campdell, M.J.3
  • 35
    • 0026633708 scopus 로고
    • The Lancet's statistical review process: Areas for improvement by authors
    • Gore SM, Jones G, Thompson SG. The Lancet's statistical review process: areas for improvement by authors. Lancet 1992; 340: 100-102.
    • (1992) Lancet , vol.340 , pp. 100-102
    • Gore, S.M.1    Jones, G.2    Thompson, S.G.3
  • 36
    • 0028235603 scopus 로고
    • Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals
    • Schulz KF, Chalmers I, Grimes DA, Altman DG. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals JAMA 1994; 272: 125-128.
    • (1994) JAMA , vol.272 , pp. 125-128
    • Schulz, K.F.1    Chalmers, I.2    Grimes, D.A.3    Altman, D.G.4
  • 37
    • 0039228145 scopus 로고
    • A method for the assessment of reports of drug trials
    • Mahon WA, Daniel EE. A method for the assessment of reports of drug trials. Can Med Assoc J 1964; 90: 565-569.
    • (1964) Can Med Assoc J , vol.90 , pp. 565-569
    • Mahon, W.A.1    Daniel, E.E.2
  • 38
    • 0023216759 scopus 로고
    • Statistical problems in the reporting of clinical trials
    • Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials. N Engl J Med 1987; 317: 426-432.
    • (1987) N Engl J Med , vol.317 , pp. 426-432
    • Pocock, S.J.1    Hughes, M.D.2    Lee, R.J.3
  • 39
    • 0025169847 scopus 로고
    • Randomization and baseline comparisons in clinical trials
    • Altman DG, Doré CJ. Randomization and baseline comparisons in clinical trials. Lancet 1990; 335: 149-153.
    • (1990) Lancet , vol.335 , pp. 149-153
    • Altman, D.G.1    Doré, C.J.2
  • 40
    • 0024550344 scopus 로고
    • Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis
    • Gotzsche PC. Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Control Clin Trials 1989; 10: 31-56.
    • (1989) Control Clin Trials , vol.10 , pp. 31-56
    • Gotzsche, P.C.1
  • 41
    • 0027439484 scopus 로고
    • Clinical studies in surgical journals: Have we improved?
    • Solomon MJ, McLeod RS. Clinical studies in surgical journals: have we improved? Dis Colon Rectum 1993; 36: 43-48.
    • (1993) Dis Colon Rectum , vol.36 , pp. 43-48
    • Solomon, M.J.1    McLeod, R.S.2
  • 42
    • 85047692188 scopus 로고
    • Empirical evidence of bias: Dimensions of methodological quality associated with estimates of treatment effects in controlled trials
    • Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995; 273: 408-412.
    • (1995) JAMA , vol.273 , pp. 408-412
    • Schulz, K.F.1    Chalmers, I.2    Hayes, R.J.3    Altman, D.G.4
  • 43
    • 0023319289 scopus 로고
    • A proposal for more informative abstracts of clinical articles
    • Ad Hoc Working Group for Critical Appraisal of the Medical Literature. A proposal for more informative abstracts of clinical articles. Ann Intern Med 1987; 106: 598-604.
    • (1987) Ann Intern Med , vol.106 , pp. 598-604
  • 45
    • 0028363244 scopus 로고
    • Quality of nonstructured and structured abstracts of original research articles in the British medical journal, the Canadian medical association journal and the journal of the American medical association
    • Taddio A, Pain T, Fassos FF, Boon H, Ilersich AL, Einarson TR. Quality of nonstructured and structured abstracts of original research articles in the British Medical Journal, the Canadian Medical Association Journal and the Journal of the American Medical Association. Can Med Assoc J 1994; 150: 1.611-1.615.
    • (1994) Can Med Assoc J , vol.150 , pp. 1611-1615
    • Taddio, A.1    Pain, T.2    Fassos, F.F.3    Boon, H.4    Ilersich, A.L.5    Einarson, T.R.6
  • 46
    • 0028908548 scopus 로고
    • Reporting randomized controlled trials: An experiment and a call for responses from readers
    • Rennie D. Reporting randomized controlled trials: an experiment and a call for responses from readers. JAMA 1995; 273: 1.054-1.055.
    • (1995) JAMA , vol.273 , pp. 1054-1055
    • Rennie, D.1
  • 47
    • 9444255722 scopus 로고    scopus 로고
    • Improving the quality of reporting of randomized controlled trials: The CONSORT statement
    • Begg C, Cho M, Eastwood S et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996; 276: 637-639.
    • (1996) JAMA , vol.276 , pp. 637-639
    • Begg, C.1    Cho, M.2    Eastwood, S.3
  • 48
    • 0018668281 scopus 로고
    • Clinical research in general medical journals: A 30-year perspective
    • Fletcher RH, Fletcher SW. Clinical research in general medical journals: a 30-year perspective. N Engl J Med 1979; 301: 180-183.
    • (1979) N Engl J Med , vol.301 , pp. 180-183
    • Fletcher, R.H.1    Fletcher, S.W.2
  • 49
    • 0029837588 scopus 로고    scopus 로고
    • How to report randomized controlled trials: The CONSORT statement
    • Rennie D. How to report randomized controlled trials: the CONSORT statement. JAMA 1996; 276: 649.
    • (1996) JAMA , vol.276 , pp. 649
    • Rennie, D.1
  • 50
    • 0029817351 scopus 로고    scopus 로고
    • Better reporting of randomised controlled trials: The CONSORT statement
    • Altman DJ. Better reporting of randomised controlled trials: the CONSORT statement. Br Med J 1996; 313: 570-571.
    • (1996) Br Med J , vol.313 , pp. 570-571
    • Altman, D.J.1
  • 51
    • 0029788853 scopus 로고    scopus 로고
    • Lies, damn lies, and reports of randomised controlled trials
    • McNamee D, Horton R. Lies, damn lies, and reports of randomised controlled trials. Lancet 1996; 348: 562.
    • (1996) Lancet , vol.348 , pp. 562
    • McNamee, D.1    Horton, R.2
  • 52
    • 0030292293 scopus 로고    scopus 로고
    • CMAJ endorses the CONSORT statement
    • Huston P, Hoey J. CMAJ endorses the CONSORT statement. Can Med Assoc J 1996; 155: 1.277-1.279.
    • (1996) Can Med Assoc J , vol.155 , pp. 1277-1279
    • Huston, P.1    Hoey, J.2
  • 53
    • 0025099275 scopus 로고
    • Underreporting research is scientific misconduct
    • Chalmers I. Underreporting research is scientific misconduct. JAMA 1990; 263: 1.405-1.408.
    • (1990) JAMA , vol.263 , pp. 1405-1408
    • Chalmers, I.1
  • 54
    • 0027491463 scopus 로고
    • Publishing the findings of clinical research
    • Munro AJ. Publishing the findings of clinical research. Br Med J 1993; 307: 1.340-1.341.
    • (1993) Br Med J , vol.307 , pp. 1340-1341
    • Munro, A.J.1
  • 55
    • 0029040360 scopus 로고
    • Publication: An ethical imperative
    • Pearn J. Publication: an ethical imperative. Br Med J 1995; 310: 1.313-1.315
    • (1995) Br Med J , vol.310 , pp. 1313-1315
    • Pearn, J.1
  • 57
    • 0029420698 scopus 로고
    • Data handling in clinical trials: An ongoing debate
    • Jongen PJ. Data handling in clinical trials: an ongoing debate. Mult Scler 1995; 1 (Supl 1): 60-63.
    • (1995) Mult Scler , vol.1 , Issue.1 SUPL , pp. 60-63
    • Jongen, P.J.1
  • 58
    • 0030961103 scopus 로고    scopus 로고
    • Medical editors trial amnesty
    • Horton R. Medical editors trial amnesty. Lancet 1997; 350: 756.
    • (1997) Lancet , vol.350 , pp. 756
    • Horton, R.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.