The process of clinical trial design is a crucial and important step culminating in development of a clinical trial protocol. Different designs suit different questions, different scenarios. Your research hypothesis informs the aims of the trial, which in turn inform the outcomes of interest, and in turn the endpoints of the trial that you can measure, that let you test your hypothesis. You might also think about if it is useful to conduct a pilot study to test the feasibility of the research question.

Who can help?

• HNELHD Nursing and Midwifery Research Centre offer a consultation service in research design
• HMRI Clinical Research Design and Statistics Support Unit aims to provide comprehensive epidemiological and statistical support to biomedical researchers. Each HMRI affiliated researcher can access an initial complimentary consultation of 1 hour.
• The HMRI Clinical Trials Unit (CTU) can also provide advice and support during clinical trial design. If you think you might require support, consider building service costs into your study budget so that you can pay for this support.