Integrating pharmacoepidemiology into the design and conduct of clinical trials

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Pharmacoepidemiology is a relatively new field, involving the study of the use of and the effects of drugs in large numbers of people. The research techniques used are those of epidemiology. They are usually applied to postmarketing studies of the effects of drugs, although this paper will show that this restriction is not necessary or even desirable. Conventional postmarketing pharmacoepidemiologic studies differ from premarketing clinical trials in that they can use nonexperimental study designs and require much larger sample sizes. However, pharmacoepidemiologic techniques can be useful in conducting clinical trials of drugs, both premarketing and postmarketing. Premarketig clinical trials can also be designed to be more helpful to pharmacoepidemiologists. Finally, in many ways, the two fields can be viewed as perfectly complementary. Each of these are discussed in more detail.

Original languageEnglish (US)
Pages (from-to)161-168
Number of pages8
JournalJournal of Clinical Research and Drug Development
Issue number3
StatePublished - Jan 1 1988

All Science Journal Classification (ASJC) codes

  • Drug Discovery
  • Pharmacology (medical)

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