Advertisement

Appendix II International Council on Alcohol, Drugs and Traffic Safety. Guidelines on experimental studies undertaken to determine a medicinal drug’s effect on driving or skills related to driving

Abstract

Medicinal drugs are an integral part of almost all medical treatments. In relieving and curing diseases, they provide the population with a positive contribution to quality of life. Besides the beneficial effects, many commonly used medicinal drugs possess the potential for seriously impairing human performance. Concerning medicinal drugs and traffic safety, De Gier [1] states that a very conservative estimate indicates that 10 % of the adult population drives under the influence of impairing drugs with twice the risk of being involved in a traffic accident and that, assuming this figure, those drugs are causing 4,500 deaths, 135,000 injuries and 6,3 billion EURO in property damage and immediate medical care each year in Europe.

Keywords

Medicinal Drug Pharmacological Drug Effect 
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.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    De Gier JJ (2005) Drugs other than alcohol and driving in the European Union. Study conducted with support of the European Road Safety Federation and the Directorate General for Transport of the Commission of the European Communities. Institute for Human Psychopharmacology (IHP), University of Limburg, Maastricht.Google Scholar
  2. 2.
    Ferrara SD and Giorgetti R (Eds) (1992) Methodology in man-machine interaction and epidemiology on drugs and traffic safety. Experiences and guidelines from an International Workshop. Addiction Research Foundation of Italy (ARFI)-Research Monograph Series Nr. 6, Padova.Google Scholar
  3. 3.
    De Gier JJ and Laurell H (1992) Studies on man-machine interaction. In: Ferrara SD, Giorgetti R. (Eds): Methodology in man-machine interaction and epidemiology on drugs and traffic safety. Experiences and guidelines from an International Workshop (pp. 33–50), Addiction Research Foundation of Italy (ARFI)-Research Monograph Series Nr. 6, Padova.Google Scholar
  4. 4.
    Vermeeren A, De Gier JJ, O’Hanlon JF (1993) Methodical guidelines for experimental research on medicinal drugs affecting driving performance-an international expert survey. Institute for Human Psychopharmacology (IHP), University of Limburg, Maastricht.Google Scholar
  5. 5.
    Vermeeren A, de Gier JJ, O’Hanlon JF, Laurell H (1993) An expert survey on methodology of experimental research in drugs and driving. In: Utzelmann, H.D., Berghaus, G., Kroj, G. (Eds): Alcohol, drugs and traffic safety-T92. pp. 795–803, TÜV Rheinland, Cologne.Google Scholar
  6. 6.
    EC: Good clinical practice: guidelines for essential documents for the conduct of a clinical trial.-In: Note for Guidance. CPMP-Commission of the European Communities (1994).Google Scholar
  7. 7.
    WHO: Guidelines for good clinical research practice (GCP) for trials on pharmaceutical products, current draft. WHO Division of Drug Management and Policies, Geneva.Google Scholar
  8. 8.
    Biostatistical methodology in clinical trials in application for marketing authorizations for medicinal products.-In: Note for Guidance. CPMP-Commission of the European Communities, 1994Google Scholar
  9. 9.
    FDA: Guidelines for the format and content of the clinical and statistical sections of new drug applications. U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drug Evaluation and Research, Rockville Md, 1988Google Scholar
  10. 10.
    International conference on harmonization of technical requirements for registration of phamaceuticals for human use (ICH): Structure and content of clinical study reports. Efficacy Topic E3, Oct. 27, Draft 10, 1994Google Scholar
  11. 11.
    Berghaus G and Friedel B (1992) Quality assurance elements and standardization of empirical studies on the subject “drugs and traffic safety”. J Traffic Med 20, 71–82.Google Scholar
  12. 12.
    Berghaus G and Friedel B (1992) Empirical man-machine interaction studies. Proposed flow-chart. In: Ferrrara SA, Giorgetti R (Eds): Methodology in man-machine interaction and epidemiology on drugs and traffic safety. Experiences and guidelines from an International Workshop. Addiction Research Foundation of Italy (ARFI)-Research Monograph Series Nr. 6, Padova.Google Scholar
  13. 13.
    International Council on Alcohol, Drugs and Traffic Safety (ICADTS): Guidelines on empirical studies undertaken to determine a medicinal drug’s effect on driving or skills related to driving-Detailed report-, 1999Google Scholar
  14. 14.
    Westlake WJ (1979) Statistical aspects of comparative bioavailability trials. Biometrics 35, 273–280.PubMedCrossRefGoogle Scholar
  15. 15.
    O’Brian PC (1984) Procedures for comparing samples with multiple endpoints. Biometrics 40, 1079–1087CrossRefGoogle Scholar
  16. 16.
    Hilgers RD, Friedel B, Berghaus G (1998) Äquivalenztestung im Rahmen experimenteller Untersuchungen zur Fahrtüchtigkeit. In Kongreßbericht 1997 der Deutschen Gesellschaft für Verkehrsmedizin e.V., pp. 130 to 134, Berichte der Bundesanstalt für Straßenwesen, Mensch und Sicherheit, Heft M92Google Scholar
  17. 17.
    Lehmacher W, Wassmer G, Reitmeir P (1991) Procedures for two sample comparisons with multiple endpoints controlling the experimentwise error rate. Biometrics 47, 511–521PubMedCrossRefGoogle Scholar
  18. 18.
    Pocock SJ, Geller NL, Tsiatis AA (1987) The analysis of multiple endpoints in clinical trials. Biometrics 43, 487–498PubMedCrossRefGoogle Scholar

Copyright information

© Birkhäuser Verlag/Switzerland 2009

Personalised recommendations