A pilot study is a small preparatory investigation that is not intended to directly address a research question, instead aimed at collecting information that may lead to a larger grant for definitive hypothesis testing. The specific aims of a pilot study are limited in number and scope, emphasizing the importance of the designated area of inquiry and any potential products. Study methods and procedures in a pilot study may still be under development as investigators decide how to collect variables and test for safety.
In accordance with the limited scope of a pilot study, the proposal, analysis, and budget are often considerably shorter or smaller than those of a larger grant study. These aspects will vary by specific award.
Some general types of pilot studies include:
- Proof of Principle: A demonstration that a mechanism or pathway is involved in a certain situation.
- Measurement Refinement: A systematic investigation of the characteristics of a measurement to optimize its use in future research.
- Outcome Variance for Sample Size Estimation: Establishing the frequency or distributional characteristics of the intended study outcome.
- Feasibility Plot: An investigation of the ability of key study components to achieve the operational aims.
- Intermediate Endpoint: Demonstrate the effect of an intervention on an intermediate endpoint thought to be causally related to a more clinically relevant outcome.
Please note that these are very general descriptions and that individual studies will often combine various pilot goals. Review the specific award opportunity for more detailed criteria.