What question did this study set out to answer?

To audit and describe sample sizes and justification practices for pilot and feasibility randomized controlled trials registered on the United Kingdom Clinical Research Network database.

August 20, 2013BMC Medical Research MethodologyOpen Access

An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database

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Authors

SBSophie BillinghamUniversity of Sheffield AWAmy WhiteheadUniversity Hospital Southampton NHS Foundation Trust SJSteven A. JuliousUniversity of Sheffield

Discussion

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Implication

Registry audit reveals sample size distributions in pilot randomised trials, highlighting how feasibility studies justify enrollment without formal calculations.

Key Points

To audit and describe sample sizes and justification practices for pilot and feasibility randomized controlled trials registered on the United Kingdom Clinical Research Network database.
Conducted an audit of pilot and feasibility randomized controlled trials registered within the United Kingdom Clinical Research Network (UKCRN) database.
Assessed documented sample sizes alongside the presence and appropriateness of formal sample size calculations versus justifications.
Demonstrated that formal mathematical sample size calculations are often unnecessary or inappropriate for pilot and feasibility trials, whereas sample size justifications remain essential.
Profiled the observed distributions of target sample sizes across early-phase feasibility and pilot trials within the national registry.

Cite This Study

Billingham et al. (2013) studied this question.

synapsesocial.com/papers/69d7227aef370a38abf50dc6 https://doi.org/10.1186/1471-2288-13-104

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Implication

Registry audit reveals sample size distributions in pilot randomised trials, highlighting how feasibility studies justify enrollment without formal calculations.

An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database

Discussion

Member takes

Implication

Key Points

Cite This Study

An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database

Discussion

Member takes

Implication

Key Points

Cite This Study

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