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Volumn 318, Issue 7, 2017, Pages 614-616

Balancing the need for access with the imperative for empirical evidence of benefit and risk

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN; RISK;

EID: 85027863984     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2017.9412     Document Type: Editorial
Times cited : (7)

References (13)
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    • Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration
    • Naci H, Smalley KR, Kesselheim AS. Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration. JAMA. doi:10.1001/jama.2017.9415
    • JAMA
    • Naci, H.1    Smalley, K.R.2    Kesselheim, A.S.3
  • 2
    • 85027831089 scopus 로고    scopus 로고
    • Characteristics of clinical studies used for US Food and Drug Administration approval of high-risk medical device supplements
    • Zheng SY, Dhruva SS, Redberg RF. Characteristics of clinical studies used for US Food and Drug Administration approval of high-risk medical device supplements. JAMA. doi:10.1001 /jama.2017.9414
    • JAMA
    • Zheng, S.Y.1    Dhruva, S.S.2    Redberg, R.F.3
  • 5
    • 85027867451 scopus 로고    scopus 로고
    • 21 USC §355
    • New Drugs, 21 USC §355 (2016).
    • (2016) New Drugs
  • 6
    • 85013663120 scopus 로고    scopus 로고
    • Accelerating development of scientific evidence for medical products within the existing US regulatory framework
    • Sherman RE, Davies KM, Robb MA, Hunter NL, Califf RM. Accelerating development of scientific evidence for medical products within the existing US regulatory framework. Nat Rev Drug Discov. 2017;16(5):297-298.
    • (2017) Nat Rev Drug Discov , vol.16 , Issue.5 , pp. 297-298
    • Sherman, R.E.1    Davies, K.M.2    Robb, M.A.3    Hunter, N.L.4    Califf, R.M.5
  • 7
    • 0030268577 scopus 로고    scopus 로고
    • Surrogate end points in clinical trials: Are we being misled?
    • Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med. 1996;125(7):605-613.
    • (1996) Ann Intern Med , vol.125 , Issue.7 , pp. 605-613
    • Fleming, T.R.1    DeMets, D.L.2
  • 8
    • 84898731305 scopus 로고    scopus 로고
    • A controlled trial of renal denervation for resistant hypertension
    • Bhatt DL, Kandzari DE, O’Neill WW, et al; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014;370(15):1393-1401.
    • (2014) N Engl J Med , vol.370 , Issue.15 , pp. 1393-1401
    • Bhatt, D.L.1    Kandzari, D.E.2    O’Neill, W.W.3
  • 10
    • 84859511256 scopus 로고    scopus 로고
    • National Center for Advancing Translational Sciences, Accessed July 21, 2017
    • National Center for Advancing Translational Sciences, National Institutes of Health. Clinical and Translational Science Awards (CTSA) Program. https://ncats.nih.gov/ctsa. Accessed July 21, 2017.
    • Clinical and Translational Science Awards (CTSA) Program
  • 11
  • 13
    • 84999025038 scopus 로고    scopus 로고
    • Need for a National Evaluation System for Health Technology
    • Shuren J, Califf RM. Need for a National Evaluation System for Health Technology. JAMA. 2016;316(11):1153-1154.
    • (2016) JAMA , vol.316 , Issue.11 , pp. 1153-1154
    • Shuren, J.1    Califf, R.M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.