The Impact of Clinical Trials on Clinical Practice

  • C. D. Furberg
Conference paper
Part of the Bayer AG Centenary Symposium book series (BAYER)

Abstract

In the process of deciding whether to fund a clinical trial, the sponsor weighs the investment of dollars, effort, and time against the information the trial is likely to generate. Varying objectives are reflected in the trial design. For example, a new drug goes through several phases of development, from dose-response studies to large, randomized clinical trials. Industry-sponsored, large-scale trials are primarily designed to document an anticipated beneficial effect, while federal agencies or foundations may have a broader interest in determining whether an intervention effect is beneficial, indifferent, or even harmful. It is important to distinguish between these goals in any analysis of the impact of clinical trials on medical practice. Moreover, it should be recognized that clinical practice itself cannot be measured directly. Indirect measures such as number of patient visits by clinical diagnosis as well as drug prescriptions or sales can indicate the impact of clinical trials. Physician interviews can provide additional information in terms of knowledge, prescription habits, perceived effectiveness, and safety. However, this approach has drawbacks, including cost.

Keywords

Cholesterol Sugar Marketing Assure Expense 

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References

  1. 1.
    Fineberg HV (1987) Clinical evaluation: how does it influence medical practice? Bull Cancer 74: 333–346PubMedGoogle Scholar
  2. 2.
    Friedman L, Wenger NK, Knatterud GL (1983) Impact of the Coronary Drug Project findings on clinical practice. Controlled Clin Trials 4: 513–522PubMedCrossRefGoogle Scholar
  3. 3.
    Gilbert JP, McPeek B, Mosteller F (1977) Progress in surgery and anesthesia: benefits and risks of innovative therapy. In: Bunker JP, Barnes BA, Mosteller F (eds) Costs, risks, and benefits of surgery. Oxford University Press, New York, p 124Google Scholar
  4. 4.
    Goldman RJ, Gore JM, Alpert JS, Dalen JE (1987) Therapeutic trends in the management of patients with acute myocardial infarction (1975–1984): the Worcester Heart Attack Study. Clin Cardiol 10: 3–8CrossRefGoogle Scholar
  5. 5.
    Lipid Research Clinics Program (1984) The Lipid Research Clinics Coronary Primary Prevention Trial results. I. Reduction in incidence of coronary heart disease. JAMA 251: 351–364CrossRefGoogle Scholar
  6. 6.
    Office of Technology Assessment, US Congress (1983) The impact of randomized clinical trials on health policy and medical practice. OTA-BP-H-22. US Government Printing Office, Washington DCGoogle Scholar
  7. 7.
    Stross JK, Harlan WR (1979) The dissemination of new medical information. JAMA 241: 2622–2624PubMedCrossRefGoogle Scholar
  8. 8.
    Sussman EJ, Tsiaras WG, Soper KA (1982) Diagnosis of diabetic eye disease. JAMA 247: 3231–3234PubMedCrossRefGoogle Scholar
  9. 9.
    University Group Diabetes Program (1970) A study of the effects of hypoglycemic agents on vascular complication in patients with adult-onset diabetes. II. Mortality results. Diabetes 19 [Suppl 2]: 787–830Google Scholar
  10. 10.
    Vere D (1981) Controlled clinical trials: the current ethical debate (editorial). J R Soc Med 74: 85–88PubMedGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 1989

Authors and Affiliations

  • C. D. Furberg
    • 1
  1. 1.Center for Prevention Research & BiometryBowman Gray School of MedicineWinston-SalemUSA

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