Education And Debate

An Ethical Debate Financial ties as part of informed consent to postmarketing research: But is it research?

BMJ 1995; 310 doi: (Published 24 June 1995) Cite this as: BMJ 1995;310:1662
  1. Jeffrey S Tobias, clinical director, cancer servicesa
  1. a Middlesex Hospital, London W1N 8AA

    Clinicians in the United Kingdom are well acquainted with phase I-III studies of novel pharmaceutical agents before marketing, but the concept of phase IV research is less familiar. La Puma and colleagues ask an important question: if pharmaceutical companies are prepared to offer individual doctors financial inducement to use a new agent, should the doctor make the patient aware of this payment? Bearing in mind that substantial rewards are also commonplace for enrolment of patients in phase I-III studies, what's the difference here? Why the fuss?

    The central issue is that so little “postmarketing research” can truly be described as research at all. It is more in the nature of a marketing exercise—as the Chicago reports points out, these studies …

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