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Pilot Randomized Controlled Trial — Feasibility-First Experimental Design
A pilot randomized controlled trial (pilot RCT) is a small-scale, fully randomized experiment conducted before a definitive RCT to test the feasibility of study procedures, estimate key parameters such as recruitment rates and effect-size variability, and identify practical barriers. It uses the same randomization, intervention, and measurement protocol as the planned full trial but on a fraction of the target sample. The goal is not to confirm efficacy but to refine and justify the main trial design.
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Sources
- Thabane, L., Ma, J., Chu, R., Cheng, J., Ismaila, A., Rios, L. P., ... & Goldsmith, C. H. (2010). A tutorial on pilot studies: the what, why and how. BMC Medical Research Methodology, 10(1), 1. DOI: 10.1186/1471-2288-10-1 ↗
- Lancaster, G. A., Dodd, S., & Williamson, P. R. (2004). Design and analysis of pilot studies: recommendations for good practice. Journal of Evaluation in Clinical Practice, 10(2), 307-312. link ↗