Abstract

It has been argued that trials inadequately powered to detect small effects are unethical. However, this narrow statistical view ignores other consequences of the conduct of large trials, particularly in relation to diseases which are rapidly lethal. These consequences include enormous increases in cost and complexity which ensure that only entities with patent protection and major financial backing can be tested. Large trials also use a substantial part of the available patent population and prevent other products being tested. Patients with lethal diseases are ill served by this situation. In order to make progress we need to conduct many more small trials looking for large effects. It is concluded that large trials in diseases which kill patients quickly are usually unethical.