Education And Debate

An Ethical Debate Financial ties as part of informed consent to postmarketing research: Defining surveillance

BMJ 1995; 310 doi: https://doi.org/10.1136/bmj.310.6995.1662 (Published 24 June 1995) Cite this as: BMJ 1995;310:1662
  1. Malcolm Vandenburg,
  2. Ian Dews
  1. IBRD Rostrum, Romford RM7 9QD Malcolm VandenBurg, chief executive officer.

    The authors of this study seem to confuse postmarketing surveillance and phase IV trials. Phase IV trials are interventional studies yielding efficacy, dosage, safety, and pharmacoeconomic data to supplement those available at the time of licensing. They are analogous to phase II and III studies and raise no separate ethical or financial issues; the doctor who had received $5000 per patient was doubtless undertaking such a study.

    Postmarketing surveillance, in contrast, uses non-interventional cohort observation to collect large scale safety data from routine clinical use. Patients are accumulated through normal prescribing, not actively recruited. No special examinations or tests are performed. The doctor's work is limited to passive …

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