The article Application of Methods for CentralStatistical Monitoring in Clinical Trials

Chapter 14, Problem 4

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The article Application of Methods for CentralStatistical Monitoring in Clinical Trials (ClinicalTrials, 2013: 783806) made a strong case for central statisticalmonitoring as an alternative to more expensiveonsite data verification. It suggested various methods foridentifying data characteristics such as outliers, incorrectdates, anomalous data patterns, unusual correlation structures,and digit preference. Exercise 3.21 of this bookintroduced Benfords Law, which gives a probabilitymodel for the first significant digit in many large data sets:p(x) 5 log10((x 1 1)/x) for x 5 1, 2, , 9. The cited articlegave the following frequencies for the first significant digitin a variety of variables whose values were determined inone particular clinical trial:Digit 1 2 3 4Freq. 342 180 164 155Digit 5 6 7 8 9Freq. 86 65 54 47 56Carry out a test of hypotheses to see whether or not thesefrequencies are consistent with Benfords Law (the citedarticle gave P-value information).

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