Clinical trials without consent: some experiments simply cannot be done

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 thrombo-lytic 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. Inherent in the trial were a number of diversions from standard treatment and procedures. These included contravening the standard advice provided to the community regarding emergency cardiac care — to attend the nearest hospital emergency department as quickly as possible; interference in established therapeutic networks and ongoing therapeutic relationships, including relationships with hospitals ; and, most importantly, delays in time to treatment. Delays in time to treatment were to be caused by: ■ Performing a resting 12-lead electrocardiogram (ECG) at the point of ambulance pickup of patients with cardiac symptoms for the purpose of the selection and allocation of trial subjects; ■ Informing the allocating person at the ambulance control centre of the computer report of the ECG and awaiting randomisation; ■ Transport of subjects randomised to the experimental group past hospitals with facilities for thrombolytic treatment and a private tertiary hospital providing acute invasive cardiac procedures, thereby adding up to about 40 km of suburban roads to the emergency dash. ■ Adding uncontrolled clinical variables (eg, intercurrent illnesses) and location difficulties caused by heavy traffic at peak periods, a lift bridge and intermittent road closures due to environmental hazards (eg, low-level flooding, bushfires). It was evident from all the MJA articles that many people within the profession and in the community opposed the trial. There are several reasons for this opposition, including: ■ local geographical issues of transport and the present distribution of health services; ■ issues of risk and inconvenience …