Clinical trials without consent: some experiments simply cannot be done

Michael C Kennedy
Med J Aust 2002; 177 (1): . || doi: 10.5694/j.1326-5377.2002.tb04635.x
Published online: 1 July 2002

Three articles in the Christmas issue of the Journal,1-3 responding to media coverage of a proposed clinical trial,4 failed to address the objections raised to conducting the trial without patient consent. The proposed trial, the Royal North Shore (RNSH) and Ambulance Regional Study of a Stenting Strategy as an Alternative to Lytic/Medical Therapy in Acute Myocardial Infarction (RARE SALAMI), was to be conducted in Sydney's Northern Area Health Service. The aim was to compare two regimens of management of patients with acute myocardial infarction and determine whether, despite some additional transit time, diverting ambulances past local hospitals (where patients would receive thrombolytic treatment) and on to the services at RNSH (where patients would be treated with percutaneous coronary intervention) would be beneficial to patients (Box 1).1 The trial would involve the ambulance service, RNSH and the emergency departments of four district hospitals within the health area. Senior medical staff from two of the emergency departments were among those who expressed concerns in the media reports.4

  • Michael C Kennedy

  • Manly Non-Invasive Cardiac Laboratory, Manly, NSW.



The author wishes to thank the four MJA reviewers and Judith Kennedy for helpful suggestions.


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