Frances Shiely
University College Cork, Ireland

Aim
The purpose of this chapter is to introduce students to the concept of trial methodology, the science of research on research to make trials more efficient.

Summary
This chapter addresses trials methodology research (TMR) as an embedded feature of clinical trials training. Trials Methodology Research is about looking at the way health research is conducted, i.e., improving the tools and trade of research practice. Its purpose is to strengthen the methodology and reporting of clinical trials. There are specific challenges in clinical trials which affect the efficiency and internal and external validity of trials: recruitment, retention, patient and public involvement throughout the lifecycle of the trial, outcome selection, reporting and dissemination of trial results, to name but a few. This chapter will address these issues, and train the student on methods of addressing these challenges through evidence based research alongside, or within (SWATs - Studies Within A Trial) clinical trials. The students will learn about existing priorities in recruitment and retention, developed via a priority setting partnership, and how best to address incorporating these challenges in the design of their trial.