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Sensitivity of Therapeutic Trials: Sequential Analysis: Peeking at Interim Results: Is it Scientific? Is it Ethical?

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Drug Development, Regulatory Assessment, and Postmarketing Surveillance

Part of the book series: NATO Advanced Study Institutes Series ((NSSA,volume 39))

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Abstract

Therapeutic trials are always expensive in terms of time of highly trained medical/scientific personnel and often in terms of money for extra staff and supporting service. They are also tedious to perform even where positive results may be expected. Therefore, it is important that they should be neither larger nor more prolonged than is necessary to obtain a definite result. This is easy to say but hard to do.

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References

  1. J.W. Tukey, Some thoughts on clinical trials, especially problems of multiplicity, Science, 198: 679 (1977)

    Article  PubMed  CAS  Google Scholar 

  2. R. Peto, M.C. Pike, P. Armitage, N.E. Breslow, D.R. Cox, S.V. Howard, N. Mantel, K. McPherson, J. Peto and P.G. Smith, Design and analysis of randomized clinical trials requiring prolonged observation of each patient, Br.J.Cancer, 34: 585 (1976). 35: 1 (1977)

    Article  PubMed  CAS  Google Scholar 

  3. P. Armitage, Sequential Medical Trials, Blackwell, Oxford (1975)

    Google Scholar 

  4. A. Brown, S.D. Mohamed, R.D. Montgomery, P. Armitage and D.R. Laurence, Value of a large dose of antitoxin in clinical tetanus, Lancet, 1: 227 (1960)

    Article  Google Scholar 

  5. A.O. Lucas, A.J. Willis, S.D. Mohamed, R.D. Montgomery, H. Steiner, P. Armitage and D.R. Laurence, A comparison of the value of 500,000 IU tetanus antitoxin (horse) with 200,000 IU in the treatment of tetanus, Clin.Pharmacol. Therap. 6: 592 (1965)

    CAS  Google Scholar 

  6. B.J. Vakil, T.H. Tulpule, P. Armitage and D.R. Laurence, A comparison of the value of 200,000 IU tetanus antitoxin with 50,000 IU in the treatment of tetanus, Clin.Pharmacol. Therap., 4: 182 (1963)

    CAS  Google Scholar 

  7. B.J. Vakil, T.H. Tulpule, P. Armitage and D.R. Laurence, A comparison of the value of 200,000 IU tetanus antitoxin (horse) with 20,000 IU in the treatment of tetanus, Clin. Pharmacol.Therap., 5: 695 (1964)

    CAS  Google Scholar 

  8. B.J. Vakil, T.H. Tulpule, P. Armitage and D.R. Laurence, A comparison of the value of 200,000 IU tetanus antitoxin (horse) with 10,000 IU in the treatment of tetanus, Clin. Pharmacol.Therap. 9: 465 (1968)

    CAS  Google Scholar 

  9. B.J. Vakil, P. Armitage, R.E. Clifford and D.R. Laurence, Therapeutic trial of intracisternal human tetanus immunoglobulin in clinical tetanus, Trans.Roy.Soc.Trop.Med.Hyg., 73: 579 (1979)

    Article  PubMed  CAS  Google Scholar 

  10. Ditchley Report, The scientific and ethical basis of the clinical evaluation of medicines, Eur. J. Clin. Pharmacol. 18: 129 (1980)

    Article  Google Scholar 

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© 1981 Springer Science+Business Media New York

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Laurence, D.R. (1981). Sensitivity of Therapeutic Trials: Sequential Analysis: Peeking at Interim Results: Is it Scientific? Is it Ethical?. In: Wardell, W.M., Velo, G. (eds) Drug Development, Regulatory Assessment, and Postmarketing Surveillance. NATO Advanced Study Institutes Series, vol 39. Springer, Boston, MA. https://doi.org/10.1007/978-1-4684-4055-3_11

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  • DOI: https://doi.org/10.1007/978-1-4684-4055-3_11

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4684-4057-7

  • Online ISBN: 978-1-4684-4055-3

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