In clinical
research and development, it is always a concern to the principal investigator
that the research finding does not reach statistical significance, i.e., it is purely
by chance alone, and the significant research finding is not reproducible under
the same experimental conditions with the same experimental units. Typicalexamples include results from genomic studies for screening of relevant genesas predictors of clinical outcomes for building of a medical predictive model
for critical and/or life-threatening diseases are often not reproducible and clinical
results from two pivotal trials for demonstration of safety and efficacy of a
test treatment under investigation are not consistent.
In practice,
it is then of particular interest to assess the validity/ reliability and
reproducibility of the research findings obtained from studies conducted in
pharmaceutical and/or clinical research and development.
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