Abstract
The development and validation of biomarkers can often follow well-established principles of scientific investigation, but implementation of biomarkers into drug development requires careful consideration of many other practical issues. During the study planning process, careful consideration must be given to the suitability of the biomarker for the specific needs and objectives of the drug development team, performance of the biomarker at the specific sites, standardization and data transmittal, potential use of the biomarker at other stages in the life cycle of the compound, and a clear understanding of how the results will be used to make decisions about the compound. A close collaboration between the biomarker expert and the drug development team is needed maximize the likelihood that the full value of the biomarker will be realized.
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