메뉴 건너뛰기




Volumn 27, Issue 1, 2016, Pages 192-198

The reporting of adverse events in oncology phase III trials: A comparison of the current status versus the expectations of the EORTC members

Author keywords

Adverse events; CONSORT statement; EORTC; Grade 5 adverse events; Phase III trial reports

Indexed keywords

ARTICLE; BREAST CANCER; CANCER RESEARCH; CLINICAL PRACTICE; CLINICAL STUDY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TOLERABILITY; HEALTH CARE SURVEY; HEALTH PROGRAM; HUMAN; MEDICAL LITERATURE; MEDICAL SOCIETY; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PUBLICATION; SYSTEMATIC REVIEW; URINARY TRACT CANCER; COMPARATIVE STUDY; EUROPE; NEOPLASMS; PRACTICE GUIDELINE;

EID: 84960106030     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdv485     Document Type: Article
Times cited : (22)

References (13)
  • 1
    • 0030668793 scopus 로고    scopus 로고
    • The impact of high-risk patients on the results of clinical trials
    • Ioannidis JPA, Lau J. The impact of high-risk patients on the results of clinical trials. J Clin Epidemiol 1997; 50(10): 1089-98.
    • (1997) J Clin Epidemiol , vol.50 , Issue.10 , pp. 1089-1098
    • Ioannidis, J.P.A.1    Lau, J.2
  • 2
    • 0035901579 scopus 로고    scopus 로고
    • The Revised CONSORT Statement for Reporting Randomized Trials: explanation and elaboration
    • Altman DG, Schulz KF, Moher D et al. The Revised CONSORT Statement for Reporting Randomized Trials: explanation and elaboration. Ann Intern Med 2001; 134(8): 663-94.
    • (2001) Ann Intern Med , vol.134 , Issue.8 , pp. 663-694
    • Altman, D.G.1    Schulz, K.F.2    Moher, D.3
  • 3
    • 8744229000 scopus 로고    scopus 로고
    • Better reporting of harms in randomized trials: an extension of the CONSORT statement
    • Ioannidis JP, Evans SJ, Gøtzsche PC et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004; 141(10): 781-8.
    • (2004) Ann Intern Med , vol.141 , Issue.10 , pp. 781-788
    • Ioannidis, J.P.1    Evans, S.J.2    Gøtzsche, P.C.3
  • 4
    • 70350489859 scopus 로고    scopus 로고
    • REporting of safety results in published reports of randomized controlled trials
    • Pitrou I, Boutron I, Ahmad N, Ravaud P. REporting of safety results in published reports of randomized controlled trials. Arch Intern Med 2009; 169(19): 1756-61.
    • (2009) Arch Intern Med , vol.169 , Issue.19 , pp. 1756-1761
    • Pitrou, I.1    Boutron, I.2    Ahmad, N.3    Ravaud, P.4
  • 5
    • 78649832568 scopus 로고    scopus 로고
    • Low quality of reporting adverse drug reactions in paediatric randomised controlled trials
    • Vries TW, de van Roon EN. Low quality of reporting adverse drug reactions in paediatric randomised controlled trials. Arch Dis Child 2010; 95(12): 1023-6.
    • (2010) Arch Dis Child , vol.95 , Issue.12 , pp. 1023-1026
    • Vries, T.W.1    de van Roon, E.N.2
  • 6
    • 78650517607 scopus 로고    scopus 로고
    • The quality of safety reporting in trials is still suboptimal: survey of major general medical journals
    • Haidich A-B, Birtsou C, Dardavessis T et al. The quality of safety reporting in trials is still suboptimal: survey of major general medical journals. J Clin Epidemiol 2011; 64(2): 124-35.
    • (2011) J Clin Epidemiol , vol.64 , Issue.2 , pp. 124-135
    • Haidich, A.-B.1    Birtsou, C.2    Dardavessis, T.3
  • 7
    • 77950516808 scopus 로고    scopus 로고
    • Reporting of harm in randomized controlled trials published in the urological literature
    • Breau RH, Gaboury I, Scales CD, Jr et al. Reporting of harm in randomized controlled trials published in the urological literature. J Urol 2010; 183(5): 1693-7.
    • (2010) J Urol , vol.183 , Issue.5 , pp. 1693-1697
    • Breau, R.H.1    Gaboury, I.2    Scales, C.D.3
  • 8
    • 84891646690 scopus 로고    scopus 로고
    • Adherence to CONSORT adverse event reporting guidelines in randomized clinical trials evaluating systemic cancer therapy: a systematic review
    • Péron J, Maillet D, Gan HK, Chen EX, You B. Adherence to CONSORT adverse event reporting guidelines in randomized clinical trials evaluating systemic cancer therapy: a systematic review. JCO 2013; 31(31): 3957-63.
    • (2013) JCO , vol.31 , Issue.31 , pp. 3957-3963
    • Péron, J.1    Maillet, D.2    Gan, H.K.3    Chen, E.X.4    You, B.5
  • 9
    • 84855595256 scopus 로고    scopus 로고
    • Consistency in the analysis and reporting of primary end points in oncology randomized controlled trials from registration to publication: a systematic review
    • You B, Gan HK, Pond G, Chen EX. Consistency in the analysis and reporting of primary end points in oncology randomized controlled trials from registration to publication: a systematic review. J Clin Oncol 2012; 30(2): 210-6.
    • (2012) J Clin Oncol , vol.30 , Issue.2 , pp. 210-216
    • You, B.1    Gan, H.K.2    Pond, G.3    Chen, E.X.4
  • 10
    • 84860121016 scopus 로고    scopus 로고
    • Assumptions of expected benefits in randomized phase III trials evaluating systemic treatments for cancer
    • Gan HK, You B, Pond GR, Chen EX. Assumptions of expected benefits in randomized phase III trials evaluating systemic treatments for cancer. J Natl Cancer Inst 2012; 104(8): 590-8.
    • (2012) J Natl Cancer Inst , vol.104 , Issue.8 , pp. 590-598
    • Gan, H.K.1    You, B.2    Pond, G.R.3    Chen, E.X.4
  • 11
    • 84863958704 scopus 로고    scopus 로고
    • Quality of reporting of modern randomized controlled trials in medical oncology: a systematic review
    • Péron J, Pond GR, Gan HK et al. Quality of reporting of modern randomized controlled trials in medical oncology: a systematic review. J Natl Cancer Inst 2012; 104(13): 982-9.
    • (2012) J Natl Cancer Inst , vol.104 , Issue.13 , pp. 982-989
    • Péron, J.1    Pond, G.R.2    Gan, H.K.3
  • 12
    • 84892584098 scopus 로고    scopus 로고
    • Addressing tobacco use in patients with cancer: a survey of American Society of Clinical Oncology members
    • Warren GW, Marshall JR, Cummings KM et al. Addressing tobacco use in patients with cancer: a survey of American Society of Clinical Oncology members. J Oncol Pract 2013; 9(5): 258-62.
    • (2013) J Oncol Pract , vol.9 , Issue.5 , pp. 258-262
    • Warren, G.W.1    Marshall, J.R.2    Cummings, K.M.3
  • 13
    • 59649123356 scopus 로고    scopus 로고
    • High rate of severe radiation dermatitis during radiation therapy with concurrent cetuximab in head and neck cancer: results of a survey in EORTC institutes
    • Giro C, Berger B, Bölke E et al. High rate of severe radiation dermatitis during radiation therapy with concurrent cetuximab in head and neck cancer: results of a survey in EORTC institutes. Radiother Oncol 2009; 90(2): 166-71.
    • (2009) Radiother Oncol , vol.90 , Issue.2 , pp. 166-171
    • Giro, C.1    Berger, B.2    Bölke, E.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.