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Combination of informative biomarkers in small pilot studies and estimation of sample size for extended studies

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Combination of informative biomarkers in small pilot studies and estimation of sample size for extended studies

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Background:
Biomarker candidates are defined as measurable molecules found in biological media. According to Biomarkers Definitions Working Group, 2001, biomarkers cover a rather wide range of parameters. Recently, biomarkers are used widely in medical researches, where single biomarkers may not possess the desired cause-effect association for disease classification and outcome prediction. Therefore the efforts of the researchers currently is to combine biomarkers. By new technologies like microarrays, next generation sequencing and mass spectrometry, researchers can obtain many biomarker candidates that can exceed tens of thousands. To avoid wasting money and time, it is suggested to control the number of patients strictly. However, pilot studies usually have low statistical power which reduces the chance of detecting a true effect .

Background:
Biomarker candidates are defined as measurable molecules found in biological media. According to Biomarkers Definitions Working Group, 2001, biomarkers cover a rather wide range of parameters. Recently, biomarkers are used widely in medical researches, where single biomarkers may not possess the desired cause-effect association for disease classification and outcome prediction. Therefore the efforts of the researchers currently is to combine biomarkers. By new technologies like microarrays, next generation sequencing and mass spectrometry, researchers can obtain many biomarker candidates that can exceed tens of thousands. To avoid wasting money and time, it is suggested to control the number of patients strictly. However, pilot studies usually have low statistical power which reduces the chance of detecting a true effect .

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