Early Trials on New Drugs

  • Christopher J. Bulpitt
Part of the Developments in Biostatistics and Epidemiology book series (DBEP, volume 1)


This chapter considers the ways in which early trials of new drugs differ from trials of established treatments. Greenwood and Todd [243] have defined three phases of early trials: trials to determine safety and early clinical pharmacology (phase I); trials to determine clinical efficacy and further clinical pharmacology (phase II); and trials for the early clinical development of the drug (phase III). A regulatory authority may be involved in these early trials and provide the approval necessary for the general release or marketing of a drug.


Regulatory Authority Early Trial Large Randomise Control Trial General Release Tienilic Acid 
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Copyright information

© Springer Science+Business Media Dordrecht 1983

Authors and Affiliations

  • Christopher J. Bulpitt
    • 1
    • 2
    • 3
  1. 1.Department of Medical Statistics and EpidemiologyLondon School of Hygiene and Tropical MedicineLondonUK
  2. 2.Royal Postgraduate Medical SchoolLondonUK
  3. 3.Hammersmith HospitalLondonUK

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