Lancaster, Dodd and Williamson (2004) provide methodological recommendations for the design, conduct, and interpretation of pilot studies intended to inform larger clinical trials.
The authors argue that pilot studies should be conducted within a clear methodological framework rather than simply being small versions of definitive trials. They highlight key objectives of pilot work, including testing recruitment procedures, evaluating intervention acceptability, refining data collection methods, assessing randomisation processes, and generating estimates needed for sample size calculations. The paper emphasises that pilot studies are primarily concerned with feasibility rather than hypothesis testing or demonstrating treatment effectiveness. Overall, the article provides practical guidance for improving the scientific rigour and usefulness of pilot studies in health research.