Clinical Trials Design

Clinical Trial Designs

Frances Shiely
University College Cork, Ireland

The purpose of this chapter is to provide students with a comprehensive overview for the critical aspects of designing a RCT using the SPIRIT guidelines.

Randomised trials are conducted to provide evidence to support better and more informed decisions about medicine and other healthcare initiatives. Trials support these decisions through the results generated by collecting data guided by a research question and appropriate trial design to answer this research question. Trials are designed to minimise bias as far as possible. Typical methods to reduce bias are, for example, the use of a control group, randomisation etc. The purpose of the randomised trial is assessment of efficacy, safety, or risk benefit ratio and the goal may be to show treatment superiority, non-inferiority, or equivalence when compared to placebo or standard therapy. Clinical trials are usually described based on their phase: Phase 1, 2, 3 and 4. These may include trials of therapeutic agents, prophylactic agents, diagnostic agents, surgical procedures, or health service strategies. Who is involved in the design of the trial is usually at the discretion of the principal investigator, but we would like to see a full trial design team, including, statisticians, methodologists, patients and the public representatives, research nurses, trial managers, data scientists and quality and regulatory affairs representatives. The Randomised Controlled Trial design is crucial to ensure the trial is effectively designed to collect the trial outcomes and answer the research question with high quality data.


Chapter 1- Clinical Trial Design (University College Cork, Cork, Ireland)

Final chapter

Chapter 1- Clinical Trial Design (University College Cork, Cork, Ireland)