Sample size estimation practices in research protocols submitted to Danish scientific ethics committees

Contemporary Clinical Trials Communications
Marius Mølsted Flege, Simon Francis Thomsen

Abstract

Sample size in research projects is estimated before initiation of the study to minimise type 1 and type 2 error, while keeping the study's financial cost and subject enrolment to a minimum. This study investigates project-specific factors potentially associated with correct estimation of sample size in study protocols. Examination of 189 non-commercially sponsored study protocols (84 randomised controlled trials (RCTs) and 105 non-RCT studies) submitted to the Scientific Ethics Committees of The Capitol Region of Denmark from 2013 to 2015. 119 (63%) study protocols contained a sample size calculation, with a significantly higher rate of sample size calculations in RCT vs non-RCT study protocols (76% vs. 52%, p < 0.001). Significantly more intervention studies than non-intervention studies (69% vs 52%, p = 0.020), studies including blood samples compared to those without (69% vs. 55%, p = 0.045), studies funded by a foundation donation compared to those with no funding (68% vs. 49%, p = 0.040) performed sample size calculations. Further, increasing number of sick patients enrolled (p = 0.048) and newer studies (p = 0.032) were more likely to include a sample size calculation in the protocol. Estimation of sample size is more of...Continue Reading

Methods Mentioned

BETA
X-ray
biopsies

Software Mentioned

SPSS

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