On jumbo and junkie trials: a fumbled affair, a jungle, or the ultimate solution?

P G Hugenholtz

Abstract


Important Clinical trials conducted between 1980 and 1990 provided early leads to the community of practicing cardiologists and general physicians on the fundamentals of the therapy of acute myocardial infarction. On the other hand trials like ISIS-III or GUSTO, the current giant among jumbo trials, could not solve the real problems arising in clinical practice. The large-scale clinical trials should be reserved for interventions that have been shown convincingly in smaller trials. The problem of restenosis after PTCA is discussed and the place of animal research is emphasized as the basis of the design of future clinical trials. These exciting data require a human study but with a scale that proves the efficacy of the intervention and substantiates the underlying hypothesis even in a small population.

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