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When and How to Assess Fast-changing Technologies: A Comparative Study of Medical Applications of Four Generic Technologies

BMJ 1998; 316 doi: (Published 09 May 1998) Cite this as: BMJ 1998;316:1468
  1. JP Bunker, visiting professor
  1. Department of Epidemiology and Public Health, University College London Medical School

    G Mowatt, D J Bower, J A Brebner, J A Cairns, A M Grant, L McKee

    Health Technology Assessment, £52 (free to NHS and learned bodies), pp 149

    ISSN 1366 5278

    Every encounter with a patient is an experiment, according to the old saying. Certainly, every encounter during which a new treatment is first used should be. What that experiment should be, however, is not self evident. Whether it should be a randomised clinical trial, as some have urged, is highly debatable and cannot be easily resolved.

    It may not ever be possible or desirable to randomise the first patient for a new operation or invasive diagnostic procedure, for much the same reason that the first clinical use of a new drug should not be randomised until preliminary assessments of toxicity have been completed. The introduction of new drugs offers a useful model, as one of my American colleagues suggested in a commentary entitled “Why not an FDA for surgery?”

    In phase I of the standard procedure for introducing a new drug its toxicity is first assessed in animals. Similarly, a new surgical technique can be developed in animals. Norman Shumway spent 10 years perfecting cardiac transplantation in the animal laboratory. Anti-vivisectionists …

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