Читать книгу Randomised Clinical Trials - David Machin - Страница 44

This chapter gives an overview of the general structure of a randomised clinical trial. The key components are highlighted. These include the type of patients or subjects that are likely to be relevant to the objectives of the trial and then, within this group, those who are specifically eligible for the trial in mind, the research question(s) and the choice of design. We emphasise the requirement of fully informed consent before a patient is entered into a trial, the determination as to whether or not the interventions on offer are equally appropriate for the individual concerned, the method of allocation to the alternative interventions and the subsequent patient assessments required to determine the relevant trial endpoint(s). Also, aspects associated with analysis, reporting and interpretation of the results are included. Finally, we introduce the basic ideas of a statistical model upon which the ultimate analysis of the clinical trial is based.