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Volumn 102, Issue 12, 2008, Pages 1189-1194

Data safety and monitoring boards for African clinical trials

Author keywords

Africa; Clinical trials data monitoring committees; Data safety monitoring boards; Guidelines; Monitoring; Safety

Indexed keywords

NEW DRUG;

EID: 54949158263     PISSN: 00359203     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.trstmh.2008.06.009     Document Type: Article
Times cited : (12)

References (20)
  • 1
    • 0043198131 scopus 로고    scopus 로고
    • Association of funding and conclusions in randomized drug trials
    • Bodil A.N., Wendong C., Christian G., and Lise L.K. Association of funding and conclusions in randomized drug trials. J. Am. Med. Assoc. 290 (2003) 921-928
    • (2003) J. Am. Med. Assoc. , vol.290 , pp. 921-928
    • Bodil, A.N.1    Wendong, C.2    Christian, G.3    Lise, L.K.4
  • 3
    • 0034716492 scopus 로고    scopus 로고
    • Effect of phenobarbital on seizure frequency and mortality in childhood cerebral malaria: a randomised, controlled intervention study
    • Crawley J., Waruiru C., Mithwani S., Mwangi I., Watkins W., and Ouma D. Effect of phenobarbital on seizure frequency and mortality in childhood cerebral malaria: a randomised, controlled intervention study. Lancet 355 (2000) 701-706
    • (2000) Lancet , vol.355 , pp. 701-706
    • Crawley, J.1    Waruiru, C.2    Mithwani, S.3    Mwangi, I.4    Watkins, W.5    Ouma, D.6
  • 4
    • 0033524162 scopus 로고    scopus 로고
    • The agonizing negative trend in monitoring of clinical trials
    • DeMets D.L., Pocock J.S., and Desmond G.J. The agonizing negative trend in monitoring of clinical trials. Lancet 354 (1999) 1983-1988
    • (1999) Lancet , vol.354 , pp. 1983-1988
    • DeMets, D.L.1    Pocock, J.S.2    Desmond, G.J.3
  • 6
    • 54949157172 scopus 로고    scopus 로고
    • European Medicines Agency, 2005. Committee for Medicinal Products for Human Use: Guideline on Data Monitoring Committees. EMEA, London, EMEA/CHMP/EWP/5872/03.
    • European Medicines Agency, 2005. Committee for Medicinal Products for Human Use: Guideline on Data Monitoring Committees. EMEA, London, EMEA/CHMP/EWP/5872/03.
  • 7
    • 0037183910 scopus 로고    scopus 로고
    • Randomized trial of vitamin supplements in relation to transmission of HIV-1 through breastfeeding and early child mortality
    • Fawzi W.W., Msamanga G.I., Hunter D., Renjifo B., and Antelman G. Randomized trial of vitamin supplements in relation to transmission of HIV-1 through breastfeeding and early child mortality. AIDS 16 (2002) 1935-1944
    • (2002) AIDS , vol.16 , pp. 1935-1944
    • Fawzi, W.W.1    Msamanga, G.I.2    Hunter, D.3    Renjifo, B.4    Antelman, G.5
  • 8
    • 43649105816 scopus 로고    scopus 로고
    • Maintaining confidentiality of interim data to enhance trial integrity and credibility
    • Fleming R.T., Mccall J., Moore A., Rodgers A., and Stewart R. Maintaining confidentiality of interim data to enhance trial integrity and credibility. Clin. Trials 5 (2008) 157-167
    • (2008) Clin. Trials , vol.5 , pp. 157-167
    • Fleming, R.T.1    Mccall, J.2    Moore, A.3    Rodgers, A.4    Stewart, R.5
  • 9
    • 33748646566 scopus 로고    scopus 로고
    • Clinical trials design issues: at least 10 things you should look for in clinical trials
    • Glasser S.P., and Howard G. Clinical trials design issues: at least 10 things you should look for in clinical trials. J. Clin. Pharmacol. 46 (2006) 1106-1115
    • (2006) J. Clin. Pharmacol. , vol.46 , pp. 1106-1115
    • Glasser, S.P.1    Howard, G.2
  • 11
    • 34547830379 scopus 로고    scopus 로고
    • Blinded trials taken to the test: an analysis of randomized clinical trials that report tests for the success of blinding
    • Hrobjartsson A., Forfang E., Haahr M.T., Als-Nielsen B., and Brorson S. Blinded trials taken to the test: an analysis of randomized clinical trials that report tests for the success of blinding. Int. J. Epidemiol. 36 (2007) 664-665
    • (2007) Int. J. Epidemiol. , vol.36 , pp. 664-665
    • Hrobjartsson, A.1    Forfang, E.2    Haahr, M.T.3    Als-Nielsen, B.4    Brorson, S.5
  • 12
    • 54949159226 scopus 로고    scopus 로고
    • International Conference on Harmonization, Good Clinical Practice, 1996. ICH Harmonized Tripartite Guideline on Good Clinical Practice. World Health Organization, Geneva, ICH/GCP, E6.(R1).
    • International Conference on Harmonization, Good Clinical Practice, 1996. ICH Harmonized Tripartite Guideline on Good Clinical Practice. World Health Organization, Geneva, ICH/GCP, E6.(R1).
  • 13
    • 1642414943 scopus 로고    scopus 로고
    • Design and analysis of group sequential clinical trials with multiple primary endpoints
    • Kosorok M.R., Shi Y., and DeMets D.L. Design and analysis of group sequential clinical trials with multiple primary endpoints. Biometrics 60 (2004) 134-145
    • (2004) Biometrics , vol.60 , pp. 134-145
    • Kosorok, M.R.1    Shi, Y.2    DeMets, D.L.3
  • 14
    • 33646558562 scopus 로고    scopus 로고
    • Randomized trials stopped early for harm in HIV/AIDS: a systematic survey
    • Mills E., Curtis C., Ping W., Beth R., Sonal S., and Gordon H. Randomized trials stopped early for harm in HIV/AIDS: a systematic survey. HIV Clin. Trials 7 (2006) 24-33
    • (2006) HIV Clin. Trials , vol.7 , pp. 24-33
    • Mills, E.1    Curtis, C.2    Ping, W.3    Beth, R.4    Sonal, S.5    Gordon, H.6
  • 16
    • 0018225182 scopus 로고
    • Size of cancer clinical trials and stopping rules
    • Pocock S.J. Size of cancer clinical trials and stopping rules. Br. J. Cancer 38 (1978) 757-766
    • (1978) Br. J. Cancer , vol.38 , pp. 757-766
    • Pocock, S.J.1
  • 17
    • 36849062123 scopus 로고    scopus 로고
    • Current controversies in data monitoring for clinical trials
    • Pocock S.J. Current controversies in data monitoring for clinical trials. Clin. Trials 3 (2006) 513-521
    • (2006) Clin. Trials , vol.3 , pp. 513-521
    • Pocock, S.J.1
  • 18
    • 54949158590 scopus 로고    scopus 로고
    • USDHHS, 2005. Code of Federal Regulations, Title 45 Public Welfare, Part 46 Protection of Human Subjects. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm [accessed June 2008].
    • USDHHS, 2005. Code of Federal Regulations, Title 45 Public Welfare, Part 46 Protection of Human Subjects. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm [accessed June 2008].
  • 20
    • 54949157528 scopus 로고    scopus 로고
    • WHO, 2005. Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards. World Health Organization, Geneva, WHO/TDR/GEN/Guidelines/05.1.
    • WHO, 2005. Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards. World Health Organization, Geneva, WHO/TDR/GEN/Guidelines/05.1.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.