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Volumn 12, Issue 1, 2015, Pages 12-14

Commentary: Data monitoring confidentiality and FDA transparency

Author keywords

[No Author keywords available]

Indexed keywords

ALOGLIPTIN; BIOLOGICAL FACTOR; NEW DRUG; ROSIGLITAZONE;

EID: 84922362612     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774514561047     Document Type: Note
Times cited : (3)

References (10)
  • 1
    • 84860445985 scopus 로고    scopus 로고
    • Rethinking research ethics: The case of postmarketing trials
    • London AJ, Kimmelman J and Carlisle B. Rethinking research ethics: the case of postmarketing trials. Science 2012; 336: 544-545.
    • (2012) Science , vol.336 , pp. 544-545
    • London, A.J.1    Kimmelman, J.2    Carlisle, B.3
  • 3
    • 84922374669 scopus 로고    scopus 로고
    • Protecting the confidentiality of interim data: Addressing current challenges
    • Fleming TR. Protecting the confidentiality of interim data: addressing current challenges. Clin Trials 2015; 12: 5-11.
    • (2015) Clin Trials , vol.12 , pp. 5-11
    • Fleming, T.R.1
  • 4
    • 20244368495 scopus 로고    scopus 로고
    • Issues in data monitoring and interim analysis of trials
    • Grant AM, Altman DG, Babiker AB, et al.; DAMOCLES Study Group. Issues in data monitoring and interim analysis of trials. Health Technol Assess 2005; 9: 25.
    • (2005) Health Technol Assess , vol.9 , pp. 25
    • Grant, A.M.1    Altman, D.G.2    Babiker, A.B.3
  • 6
    • 34250212715 scopus 로고    scopus 로고
    • Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes
    • Nissen SE and Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356: 2457-2471.
    • (2007) N Engl J Med , vol.356 , pp. 2457-2471
    • Nissen, S.E.1    Wolski, K.2
  • 7
    • 84904960556 scopus 로고    scopus 로고
    • FDA debates trial-data secrecy
    • Ledford H. FDA debates trial-data secrecy. Nature 2014; 511: 519.
    • (2014) Nature , vol.511 , pp. 519
    • Ledford, H.1
  • 8
    • 0035949071 scopus 로고    scopus 로고
    • Monitoring clinical trials - interim data should be publicly available
    • Lilford RJ, Braunholtz D, Edwards S, et al. Monitoring clinical trials - interim data should be publicly available. BMJ 2001; 323: 441-442.
    • (2001) BMJ , vol.323 , pp. 441-442
    • Lilford, R.J.1    Braunholtz, D.2    Edwards, S.3
  • 9
    • 84904120269 scopus 로고    scopus 로고
    • Interim results in clinical trials: Do we need to keep all interim randomised clinical trial results confidential?
    • Stephens RJ, Langley RE, Mulvenna P, et al. Interim results in clinical trials: do we need to keep all interim randomised clinical trial results confidential? Lung Cancer 2014; 85: 116-118.
    • (2014) Lung Cancer , vol.85 , pp. 116-118
    • Stephens, R.J.1    Langley, R.E.2    Mulvenna, P.3
  • 10
    • 84862777400 scopus 로고    scopus 로고
    • Adaptive licensing: Taking the next step in the evolution of drug approval
    • Eichler HG, Oye K, Baird LG, et al. Adaptive licensing: taking the next step in the evolution of drug approval. Clin Pharmacol Ther 2012; 91: 426-437.
    • (2012) Clin Pharmacol Ther , vol.91 , pp. 426-437
    • Eichler, H.G.1    Oye, K.2    Baird, L.G.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.