Abstract
Data from clinical trials involving human participants are essential in establishing an evidence base about the safety and effectiveness of our treatments. This second article describes the steps involved in designing and setting up a clinical trial, from writing a protocol to gaining the necessary approvals. Acquiring some knowledge about how to set up a clinical trial will allow the conscientious clinician to use the most relevant information to provide the highest possible standards of clinical care for his/her patients. CPD/Clinical Relevance: Even if a clinician is not, has never been, nor is ever planning to be involved in research, he/she should understand and be able to interpret the data from clinical trials.
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