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Volumn 360, Issue 9343, 2002, Pages 1345-1346

Clinical trial protocols: Agreements between the FDA and industrial sponsors

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO;

EID: 0037010409     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(02)11415-2     Document Type: Note
Times cited : (4)

References (12)
  • 1
    • 0035857966 scopus 로고    scopus 로고
    • The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomised trials
    • Moher D., Schulz K.F., Altman D.G. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 357:2001;1191-1194.
    • (2001) Lancet , vol.357 , pp. 1191-1194
    • Moher, D.1    Schulz, K.F.2    Altman, D.G.3
  • 2
    • 0034737962 scopus 로고    scopus 로고
    • What makes clinical research ethical?
    • Emanuel E., Wendler D., Grady C. What makes clinical research ethical? JAMA. 283:2000;2701-2711.
    • (2000) JAMA , vol.283 , pp. 2701-2711
    • Emanuel, E.1    Wendler, D.2    Grady, C.3
  • 3
    • 0034766675 scopus 로고    scopus 로고
    • Why randomized controlled trials fail but needn't; 2
    • Sackett D.L. Why randomized controlled trials fail but needn't; 2. Can Med Assoc J. 156:2001;1226-1237.
    • (2001) Can Med Assoc J , vol.156 , pp. 1226-1237
    • Sackett, D.L.1
  • 4
    • 0023185342 scopus 로고
    • Equipoise and the ethics of clinical research
    • Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 317:1987;141-145.
    • (1987) N Engl J Med , vol.317 , pp. 141-145
    • Freedman, B.1
  • 5
    • 0035461276 scopus 로고    scopus 로고
    • Acknowledgment about uncertainty: A fundamental means to ensure scientific and ethical validity in research
    • Djulbegovic B. Acknowledgment about uncertainty: a fundamental means to ensure scientific and ethical validity in research. Curr Oncol Rep. 3:2001;389-395.
    • (2001) Curr Oncol Rep , vol.3 , pp. 389-395
    • Djulbegovic, B.1
  • 6
    • 0028248866 scopus 로고
    • Multicenter trials and subject eligibility: Should local IRBs play a role?
    • Freedman B. Multicenter trials and subject eligibility: should local IRBs play a role? IRB Rev Human Subjects Res. 16:1994;1-6.
    • (1994) IRB Rev Human Subjects Res , vol.16 , pp. 1-6
    • Freedman, B.1
  • 8
    • 0011487734 scopus 로고    scopus 로고
    • US Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Special Protocol Assessment. 2002: http://www.fda.gov/cder/guidance/3764fnl.htm (accessed Aug 27, 2002).
    • (2002) Guidance for Industry: Special Protocol Assessment
  • 9
    • 0011442384 scopus 로고    scopus 로고
    • US Food and Drug Administration, Center for Devices and Radiological Health. Code of Federal Regulations Title 21: Food and Drugs. 2002: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ showCFR.cfm?CFRPart=56 (accessed Aug 27, 2002).
    • (2002) Code of Federal Regulations Title 21: Food and Drugs
  • 11
    • 0000303257 scopus 로고    scopus 로고
    • Availability for public disclosure and submission to FDA for public disclosure of certain data and information related to human gene therapy or xenotransplantation
    • Anonymous. Availability for public disclosure and submission to FDA for public disclosure of certain data and information related to human gene therapy or xenotransplantation. US Fed Reg 2001; 66: 4688-706.
    • (2001) US Fed Reg , vol.66 , pp. 4688-4706
  • 12
    • 3042692507 scopus 로고    scopus 로고
    • Publishing trial protocols: Making them visible will improve registration, reporting and recruitment
    • Godlee F. Publishing trial protocols: Making them visible will improve registration, reporting and recruitment. BMC News Views 2001; 2: 4. http://www.biomedcentral.com/1471-8219/2/4/ (accessed Sept 9, 2002).
    • (2001) BMC News Views , vol.2 , pp. 4
    • Godlee, F.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.