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FDA and Clinical Trial Data Monitoring Committees

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Data Monitoring in Clinical Trials

Based on authors’ work at the Center for Biologics Evaluation and Research, Food and Drug Administration.

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References

  1. U.S. Food and Drug Administration. 1988. Guideline for the Format and Content of the Clinical and Statistical Sections of an Application. Rockville, MD: FDA. http://www.fda.gov/cder/guidance/statnda.pdf.

    Google Scholar 

  2. Ellenberg SS, Geller N, Simon R, Yusuf S (eds.). 1993. Proceedings of “Practical Issues in Data Monitoring of Clinical Trials,” Bethesda, Maryland, USA, 27–28 January 1992. Stat Med 12:415–616.

    Google Scholar 

  3. O’Neill RT. 1993. Some FDA perspectives on data monitoring in clinical trials in drug development. Stat Med 12:601–608.

    Article  Google Scholar 

  4. O’Neill RT. 1993. A regulatory perspective on data monitoring and interim analysis. In Buncher CR, Tsay JY (eds.): Statistics in the Pharmaceutical Industry. Marcel Dekker, New York.

    Google Scholar 

  5. Title 21, US Code of Federal Regulations. Part 50.24

    Google Scholar 

  6. Ellenberg SS. 1997. Informed consent: Protection or obstacle? Some emerging issues. Control Clin Trials 18:628–636.

    Article  Google Scholar 

  7. US Food and Drug Administration. 1998. International Conference on Harmonisation: Guidance on Statistical Principles for Clinical Trials. http://www.fda.gov/cber/gdlns/ichclinical.pdf.

    Google Scholar 

  8. ICH E9 Expert Working Group 1999. ICH Harmonised Tripartite Guideline: Statistical principles for clinical trials. Stat Med 18:1905–1942.

    Google Scholar 

  9. US Food and Drug Administration. 2001. Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees. FDA, Rockville, MD. http://www.fda.gov/cber/gdlns/clindatmon.htm.

    Google Scholar 

  10. Title 21, US Code of Federal Regulations, Parts 314.500–314.560. http://straylight.law.cornell.edu/cfr/cfr.php?title=21&type=part&value=314

    Google Scholar 

  11. Murray JM, Elashoff MR, Iacono-Connors LC, Cvetkovich TA, Struble KA. 1999. The use of plasma HIV RNA as a study endpoint in efficacy trials of antiretroviral drugs. AIDS 13:797–804.

    Article  Google Scholar 

  12. Ziegler EJ, Fisher CJ Jr, Sprung CL, et al. 1991. Treatment of gram-negative bacteremia and septic shock with HA-1A human monoclonal antibody against endotoxin. A randomized, double-blind, placebo-controlled trial. The HA-1A Sepsis Study Group. N Engl J Med 324:429–436.

    Article  Google Scholar 

  13. Siegel JP. 2002. Biotechnology and clinical trials. J Infect Dis 185:S52–S57.

    Article  Google Scholar 

  14. Derkx B, Wittes J, McCloskey R. 1999. Randomized, placebo-controlled trial of HA-1A, a human monoclonal antibody to endotoxin, in children with meningococcal septic shock. European Pediatric Meningococcal Septic Shock Trial Study Group. Clin Infect Dis 28:770–777.

    Article  Google Scholar 

  15. McCloskey RV, Straube RC, Sanders C, Smith SM, Smith CR. 1994. Treatment of septic shock with human monoclonal antibody HA-1A. A randomized, double-blind, placebo-controlled trial. CHESS Trial Study Group. Ann Intern Med 121:1–5.

    Google Scholar 

  16. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. 1995. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med 333:1581–1588.

    Article  Google Scholar 

  17. PRISMS Study Group. 1998. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. Lancet 352:1498–1504.

    Article  Google Scholar 

  18. Goodkin DE. 1998. Interferon ß therapy for multiple sclerosis. Lancet 352:1486–1500.

    Article  Google Scholar 

  19. U.S. Food and Drug Administration. 1998. Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. http://www.fda.gov/cder/guidance/1397fnl.pdf

    Google Scholar 

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Ellenberg, S.S., Siegel, J.P. (2006). FDA and Clinical Trial Data Monitoring Committees. In: DeMets, D.L., Furberg, C.D., Friedman, L.M. (eds) Data Monitoring in Clinical Trials. Springer, New York, NY. https://doi.org/10.1007/0-387-30107-0_3

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