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Clinical Trials

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Part of the book series: Handbook of Experimental Pharmacology ((HEP,volume 96))

Abstract

The process of applying or administering a drug to humans, either healthy volunteers or patients, under careful observation by research physicians and directed at answering questions about the drug, is referred to as the conduct of clinical trials. Although most people would agree with this definition, one must predict that few other statements regarding aspects of clinical trials would result in uniformity of opinion. Indeed, if one were to place a value judgement on the conduct of clinical trials, such as whether they are good, or important, or necessary, or scientifically based, or unethical, vigorous disagreements would immediately emerge. Therefore, in this chapter we will only touch on a few aspects of clinical trials relevant to the study of antifungal drugs. For a general review of clinical trials numerous other texts should be consulted (e.g., Burley and Glynne 1985; Spriet and Simon 1985; World Health Organization 1975; Cioms 1983). We have attempted to place this presentation in perspective by discussing briefly in the first section why clinical trials are used in the development of new antifungal drugs.

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References

  • Bailar JC, Mosteller F (1986) Medical uses of statistics. N Engl J Med Books, Boston

    Google Scholar 

  • Barry M (1988) Ethical considerations of human investigation in developing countries:the AIDS dilemma. N Engl J Med 319: 1083–1086

    Article  PubMed  CAS  Google Scholar 

  • Bulpitt CJ (1983) Randomized, controlled clinical trials. Martinus Nijhoff, The Hague

    Google Scholar 

  • Burley DM, Glynne A (1985) Clinical trials. In: Burley DM, Binns TB (eds) Pharmaceutical medicine. Edward Arnold, London, pp 70–109

    Google Scholar 

  • Cioms (1983) Safety requirements for the first use for new drugs and diagnostic agents in man. Council for International Organization of Medical Sciences, Geneva

    Google Scholar 

  • Dismukes WE (1988) Azole antifungal drugs: old and new. Ann Int Med 109: 177–179

    PubMed  CAS  Google Scholar 

  • Farley D (1988) How FDA approves new drugs. ASM News 54: 666–670

    Google Scholar 

  • Federal Register (1987) Document 87–6064. March 19

    Google Scholar 

  • Feinstein AR (1983) An additional basic science for clinical medicine: III. The challenges of comparison and measurement. Ann Int Med 99: 705–712

    PubMed  CAS  Google Scholar 

  • Fleiss JL (1986) Analysis of data from multiclinic trials. Controlled Clin Trials 7: 267–275

    Article  PubMed  CAS  Google Scholar 

  • Freiman JA, Chalmers TC, Smith H, Kuebler RR (1978) The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. N Engl J Med 299: 690–694

    Article  PubMed  CAS  Google Scholar 

  • Idänpään-Heikkila JF (1985) Adverse events and post-marketing surveillance. In: Burley DM, Binns TB (eds) Pharmaceutical medicine. Edward Arnold, London, pp 126–148

    Google Scholar 

  • Koch G, Edwards S (1988) Biopharmaceutical statistics for drug development. Marcel Dekker, New York

    Google Scholar 

  • Monaco GP, Gottlieb MG (1987) Treatment INDs: research for hire? JAMA 258: 3296–3297

    Article  PubMed  CAS  Google Scholar 

  • National Academy of Sciences (1988) Confronting AIDS, update 1988. Institute of Medicine, National Adademy Press, Washington DC

    Google Scholar 

  • Phillips L, Steinberg M, Maibach HI, Akers WA (1972) A comparison of rabbit andhuman skin response to certain irritants. Toxicol Appl Pharamcol 21: 369–382

    Article  CAS  Google Scholar 

  • Sacks H, Chalmers TC, Smith H (1982) Randomized versus historical controls for clinical trials. Am J Med 72: 233–240

    Article  PubMed  CAS  Google Scholar 

  • Spriet A, Simon P (1985) Methodology of clinical drug trials. Karger, Basel

    Article  Google Scholar 

  • Stern JJ, Hartman BJ, Sharkey P, Rowland V, Squires KE, Murray HW, Graybill JR (1988) Oral fluconazole therapy for patients with acquired immunodeficiency syndrome and cryptococcosis: experience with 22 patients. Am J Med 85: 477–480

    Google Scholar 

  • Sugar AM, Saunders C (1988) Oral fluconazole as suppressive therapy of disseminated cryptococcosis in patients with acquired immunodeficiency syndrome. Am J Med 85: 481–489

    Article  PubMed  CAS  Google Scholar 

  • Wiklund I, Lindvall K, Swedberg K (1986) Assessment of quality of life in clinical trials. Acta Med Scand 220: 1–3

    Article  PubMed  CAS  Google Scholar 

  • World Health Organization (1975) Guidelines for evaluation of drugs for use in man. Technical Report Series 563, Geneva

    Google Scholar 

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© 1990 Springer-Verlag Berlin Heidelberg

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Jones, T.C., Stern, J.J. (1990). Clinical Trials. In: Ryley, J.F. (eds) Chemotherapy of Fungal Diseases. Handbook of Experimental Pharmacology, vol 96. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-75458-6_14

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  • DOI: https://doi.org/10.1007/978-3-642-75458-6_14

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-75460-9

  • Online ISBN: 978-3-642-75458-6

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