Heart 1997;78:535-536 ( December )
Editorial
Randomised trials of new procedures: problems and pitfalls
| The first 150 words of the full text of this article appear below. |
Forty years after the introduction of the randomised trial to assess the effectiveness of streptomycin for the treatment of tuberculosis, new drugs cannot gain clinical acceptance or regulatory approval without being tested in randomised trials. This experience has resulted in the general impression that new procedures and techniques must be validated similarly. In regard to coronary bypass surgery Hiatt suggested that "well designed trials should precede widespread dissemination, as is done to a considerable extent for drugs."1
That recommendation reveals misconceptions about the differences between trials of new drugs and trials of new procedures. Indeed, with interventional procedures becoming ever more important in the treatment of cardiovascular disorders, discussions that once seemed pertinent only to surgical therapy are now pertinent to interventional cardiovascular treatment as well.
Drugs versus proceduresTable 1 lists several obvious differences between drugs and
procedures. Drugs have an unchanging composition, but as drug use
increases, additional
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