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Clinical Trials of Radiopharmaceuticals

  • Per Juul
Part of the Developments in Nuclear Medicine book series (DNUM, volume 4)

Abstract

A drug is any substance or product that is used or intended to be used to modify or explore physiological systems or pathological states for the benefit of the patient (1). Accordingly radiopharmaceuticals whether intended for scientific investigational purposes or for diagnostic or therapeutic purposes are covered by the definition and subject to the professional principles underlying the development of drugs in general — including the clinical trials. In this respect therapeutic radiopharmaceutical drugs do not differ from ordinary drugs, whereas particular problems are involved concerning diagnostic drugs, and mainly the latter ones shall be discussed.

Keywords

Technical Report Series Clinical Trial Protocol Stepwise Progression Liver Scintigraphy Coherent Plan 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    Principles for preclinical testing of drug safety: report of WHO Scientific Group. WHO Technical Report Series, No. 341, Geneva 1966.Google Scholar
  2. 2.
    Hill AB.Controlled clinical trials. Blackwell 1960.Google Scholar
  3. 3.
    Guidelines for evaluation of drugs for use in man: report of a WHO Scientific Group. WHO Technical Report Series, No. 563, Geneva 1975.Google Scholar
  4. 4.
    Harris EL, Fitzgerald OD, eds. The principles and practice of clinical trials. Livingstone, Edingburgh and London 1970.Google Scholar
  5. 5.
    Good CS, ed. The principles and practice of clinical trials. Churchill Livingstone, Edingburgh, London and New York 1976.Google Scholar
  6. 6.
    Wardell WM, Velo G, eds. Drug development, regulatory assessment, and postmarketing surveillance. Plenum Press, New York and London 1980.Google Scholar
  7. 7.
    Cavalla JF, ed. Risk-benefit analysis in drug research. MTP Press Limited, Lancaster, Boston, The Hague 1981.Google Scholar
  8. 8.
    Lionel NDW, Herxheimer A. Assessing reports of therapeutic trials. Brit med J 1970; 3:637–640.PubMedCrossRefGoogle Scholar
  9. 9.
    Christensen E, Juhl E, Tygstrup N. Randomized clinical trials of a decade (1964 to 1974). Gastroenterol 1977; 73:1170–1178.Google Scholar
  10. 10.
    Christensen E, Juhl E, Tygstrup N. Treatment of gastric ulcer. The randomized clinical trials from 1964 to 1974 and their impact. Amer J Gastroenterol 1978; 69:272–282.Google Scholar
  11. 11.
    Freiman J A, Chalmers TC, Smith H. Kuebler RR. The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 “negative” trials. New Engl J Med 1978; 299:690–694.PubMedCrossRefGoogle Scholar
  12. 12.
    Tygstrup N, Christensen E, Juhl E. Randomisierte klinische Therapiestudien in der Hepatologie. Internist 1979; 20:565–570.PubMedGoogle Scholar
  13. 13.
    DerSimonian R, Charette L, McPeek B, Mosteller F. Reporting on methods in clinical trials. New EnglJ Med 1982; 306:1332–1337.CrossRefGoogle Scholar
  14. 14.
    Lusted MB. Introduction to medical decision making. CC Thomas, Springfield 1968.Google Scholar
  15. 15.
    Lindley DV. Making decisions. Wiley & Sons, New York 1971.Google Scholar
  16. 16.
    Koran LM. The reliability of clinical methods, data and judgements. New Engl J Med 1975; 293:642–646.PubMedCrossRefGoogle Scholar
  17. 17.
    Koran LM. The reliability of clinical methods, data and judgements. New Engl J Med 1975; 293:695–701.PubMedCrossRefGoogle Scholar
  18. 18.
    Wulff HR. Rational diagnosis and treatment. Blackwell Scientific Publications, London 1976.Google Scholar
  19. 19.
    Use of ionizing radiation and radionuclides on human beings for medical research, training, and nonmedical purposes: report of a WHO Expert Committee. WHO Technical Report Series, No. 611. Geneva 1977.Google Scholar
  20. 20.
    Guidelines for the clinical evaluation of radiopharmaceutical drugs. Food and Drug Administration 1981.Google Scholar
  21. 21.
    Gross F. Constraints of drug regulation on the development of drugs. Arch Toxicol 1979; 43:9–17.PubMedCrossRefGoogle Scholar
  22. 22.
    Gottschalk A. Radiopharmaceuticals: Admiration, enthusiasm, and despair. Year Book of Nuclear Medicine 1982: 183–86. Year Book Med Publ Inc, Chicago and London 1982.Google Scholar
  23. 23.
    Maxwell C. Clinical trials protocol. Stuart Phillips Publ., Surrey 1969.Google Scholar
  24. 24.
    Shreiner DP, Barlai-Kovach M. Diagnosis of alcoholic cirrhosis with right-to left hepatic lobe ratio: Concise communication. J Nucl Med 1981; 22:116–120PubMedGoogle Scholar
  25. 25.
    Zarafonetis CJD. Rilej PA, Willis PW, Power LH, Werbelow J, Farhat L, Beckwith W, Marks BH. Clinically significant adverse effects in phase I testing program. Clin Pharmacol Ther 1978; 24:127–132.PubMedGoogle Scholar
  26. 26.
    Rhodes BA, Cordova MM. Adverse reactions to radiopharmaceuticals: Incidence in 1978 and associated symptoms. J Nucl Med 1980; 21:1107.PubMedGoogle Scholar
  27. 27.
    Mitchell AA, Slone D, Shapiro S, Goldman P. Adverse drug effects and drug surveillance. In: Yaffe SJ, ed. Pediatric pharmacology. Grune & Stratton Inc. 1980.Google Scholar
  28. 28.
    Newbould BB. The effect of industry. In: Cavalla JF, ed. Risk-benefit analysis in drug research. MTP Press Limited, Lancaster, Boston, The Hague 1981:17–26.Google Scholar
  29. 29.
    Bond V. Radiation cancer risk; What is “safe” exposure? Proc Conf Known Effects of Low Level Radiation Exposure. NIH Publ No. 80–2087. 1980: 123–137.Google Scholar
  30. 30.
    Yerushalmy J. Statistical problems in assessing methods of medical diagnosis with special reference to X-ray technics, In: Neyman J, ed. Outline of statistical treatment of the problem of diagnosis. Pub Health Rep 1947; 62:1431.Google Scholar
  31. 31.
    Conn HO, Spencer CP. Observer error in liver scans. Gastroenterol 1972; 62:1085–1090.Google Scholar
  32. 32.
    Metz CE. Basic principles of ROC analysis. Sem Nucl Med 1978; VIII: 283–298.CrossRefGoogle Scholar
  33. 33.
    Lusted LB. General problems in medical decision making with comments on ROC analysis. Sem Nucl Med 1978; VIII: 299–306.CrossRefGoogle Scholar
  34. 34.
    Bell RS. Efficacy. Whats that?? Sem Nucl Med 1978; VIII: 316–323.CrossRefGoogle Scholar
  35. 35.
    Declaration of Helsinki. Recommendations guiding medical doctors in biomedical research involving human subjects. Tokyo 1975.Google Scholar
  36. 36.
    Research involving human subjects. WHO Drug Information. October-December 1980:2–14.Google Scholar
  37. 37.
    McNeil BJ, Pauker SG, Sox HC, Tversky A. On the elicitation of preferences for alternative therapies. New Engl J Med 1982; 21:1259–1262.CrossRefGoogle Scholar
  38. 38.
    Halperin M, Rogot E. Gurian J. Ederer F. Sample sizes for medical trials with special reference to long-term therapy. J chron Dis 1968;21:13–24.PubMedCrossRefGoogle Scholar
  39. 39.
    Feinstein AR, Clinical biostatistics XXXIV. The other side of “statistical significance”: alpha, beta, delta, and the calculation of sample size. Clin Pharmacol Ther 1975; 18:491–505.PubMedGoogle Scholar
  40. 40.
    Teates CT, Bray ST, Williamson BRJ. Tumor detection with 67-Ga-citrate: A literature survey (1970–1978). Clin Nucl med 1978; 3:456–459.PubMedCrossRefGoogle Scholar
  41. 41.
    Fritz SL, Preston DF, Gallagher JH. ROC analysis of diagnostic performance in liver scintigraphy. J Nucl Med 1981; 22:121–128.PubMedGoogle Scholar
  42. 42.
    Christensen M, Rødbro P. The diagnostic value of liver scintigraphy to disclose metastases in patients with suspected or proven gastrointestinal cancer. A critical review of the literature. Dan Med Bull 1982; 29:206–208.PubMedGoogle Scholar

Copyright information

© Martinus Nijhoff Publishers, Boston 1984

Authors and Affiliations

  • Per Juul

There are no affiliations available

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