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Volumn 20, Issue 1, 2019, Pages

Principles and procedures for data and safety monitoring in pragmatic clinical trials

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); CONTROLLED STUDY; HUMAN; HUMAN EXPERIMENT; MENTAL HEALTH RESEARCH; PRAGMATIC TRIAL; RESPONSIBILITY; RISK ASSESSMENT; TIMELINESS (DATA); ADOLESCENT; ADULT; AGED; MEASUREMENT ACCURACY; METHODOLOGY; MIDDLE AGED; RANDOMIZED CONTROLLED TRIAL (TOPIC); YOUNG ADULT;

EID: 85076318771     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-019-3869-3     Document Type: Article
Times cited : (18)

References (20)
  • 3
    • 0028924219 scopus 로고
    • Cost-effectiveness comparisons using "real world" randomized trials: The case of new antidepressant drugs
    • 1:STN:280:DyaK2M3gsFajsg%3D%3D 7897458
    • Simon G, Wagner E, VonKorff M. Cost-effectiveness comparisons using "real world" randomized trials: The case of new antidepressant drugs. J Clin Epidemiol. 1995;48:363-73.
    • (1995) J Clin Epidemiol , vol.48 , pp. 363-373
    • Simon, G.1    Wagner, E.2    VonKorff, M.3
  • 4
    • 0003770817 scopus 로고    scopus 로고
    • National Institutes of Health Services DoHaH (eds) Department of Health and Human Services Bethesda
    • National Institutes of Health. NIH policy for data and safety monitoring. In: Services DoHaH, editor. Bethesda: Department of Health and Human Services; 1998.
    • (1998) NIH Policy for Data and Safety Monitoring
  • 8
    • 85076339058 scopus 로고    scopus 로고
    • US National Library of Medicine US National Library of Medicine Bethesda [updated 2019; cited 2019 October 17, 2019];
    • US National Library of Medicine. Reducing cardiovascular risk in adults with serious mental illness (SMIWizard). Bethesda: US National Library of Medicine; 2019. [updated 2019; cited 2019 October 17, 2019]; Available from: https://clinicaltrials.gov/ct2/show/NCT02451670
    • (2019) Reducing Cardiovascular Risk in Adults with Serious Mental Illness (SMIWizard)
  • 9
    • 85076369532 scopus 로고    scopus 로고
    • US National Library of Medicine US National Library of Medicine Bethesda [updated 2019; cited 2019 October 17, 2019];
    • US National Library of Medicine. Safer Use of Antipsychotics in Youth (SUAY). Bethesda: US National Library of Medicine; 2019. [updated 2019; cited 2019 October 17, 2019]; Available from: https://clinicaltrials.gov/ct2/show/NCT03448575
    • (2019) Safer Use of Antipsychotics in Youth (SUAY)
  • 10
    • 85062986980 scopus 로고    scopus 로고
    • Improving pragmatic clinical trial design using real-world data
    • 30866672 1740774519833679
    • Shortreed SM, Rutter CM, Cook AJ, Simon GE. Improving pragmatic clinical trial design using real-world data. Clin Trials. 2019;16(3):273-82 1740774519833679.
    • (2019) Clin Trials , vol.16 , Issue.3 , pp. 273-282
    • Shortreed, S.M.1    Rutter, C.M.2    Cook, A.J.3    Simon, G.E.4
  • 11
    • 6844250797 scopus 로고    scopus 로고
    • Sample size in cluster randomisation
    • 1:STN:280:DyaK1c7mt1entg%3D%3D 9501723 2665662 PMCID: PMC2665662
    • Kerry SM, Bland JM. Sample size in cluster randomisation. BMJ. 1998;316(7130):549 PMCID: PMC2665662.
    • (1998) BMJ , vol.316 , Issue.7130 , pp. 549
    • Kerry, S.M.1    Bland, J.M.2
  • 12
    • 0032499503 scopus 로고    scopus 로고
    • The intracluster correlation coefficient in cluster randomisation
    • 1:STN:280:DyaK1c3jvFKisQ%3D%3D 9572764 1113123 PMCID: PMC1113123
    • Kerry SM, Bland JM. The intracluster correlation coefficient in cluster randomisation. BMJ. 1998;316(7142):1455 PMCID: PMC1113123.
    • (1998) BMJ , vol.316 , Issue.7142 , pp. 1455
    • Kerry, S.M.1    Bland, J.M.2
  • 13
    • 85030629082 scopus 로고    scopus 로고
    • Per-protocol analyses of pragmatic trials
    • 28976864
    • Hernan MA, Robins JM. Per-protocol analyses of pragmatic trials. N Engl J Med. 2017;377(14):1391-8.
    • (2017) N Engl J Med , vol.377 , Issue.14 , pp. 1391-1398
    • Hernan, M.A.1    Robins, J.M.2
  • 14
    • 0014115513 scopus 로고
    • Explanatory and pragmatic attitudes in therapeutical trials
    • Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1957;20:637-48.
    • (1957) J Chronic Dis , vol.20 , pp. 637-648
    • Schwartz, D.1    Lellouch, J.2
  • 16
    • 84879854301 scopus 로고    scopus 로고
    • Data quality assessment for comparative effectiveness research in distributed data networks
    • 23793049 4306391 PMCID: PMC4306391
    • Brown JS, Kahn M, Toh S. Data quality assessment for comparative effectiveness research in distributed data networks. Med Care. 2013;51(8 Suppl 3):S22-9 PMCID: PMC4306391.
    • (2013) Med Care , vol.51 , Issue.8 , pp. S22-S29
    • Brown, J.S.1    Kahn, M.2    Toh, S.3
  • 18
    • 85014104700 scopus 로고    scopus 로고
    • Changes in coding of suicide attempts or self-harm with transition from ICD-9 to ICD-10
    • 27903145
    • Stewart C, Crawford PM, Simon GE. Changes in coding of suicide attempts or self-harm with transition from ICD-9 to ICD-10. Psychiatr Serv. 2017;68(3):215.
    • (2017) Psychiatr Serv , vol.68 , Issue.3 , pp. 215
    • Stewart, C.1    Crawford, P.M.2    Simon, G.E.3
  • 19
    • 0018687930 scopus 로고
    • A multiple testing procedure for clinical trials
    • 1:STN:280:DyaL3c%2Fktlehsw%3D%3D 497341
    • O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979;35(3):549-56.
    • (1979) Biometrics. , vol.35 , Issue.3 , pp. 549-556
    • O'Brien, P.C.1    Fleming, T.R.2
  • 20
    • 84922374669 scopus 로고    scopus 로고
    • Protecting the confidentiality of interim data: Addressing current challenges
    • 25475877 PMCID: PMC4344915
    • Fleming TR. Protecting the confidentiality of interim data: addressing current challenges. Clin Trials. 2015;12(1):5-11 PMCID: PMC4344915.
    • (2015) Clin Trials , vol.12 , Issue.1 , pp. 5-11
    • Fleming, T.R.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.