“Genomic advances and their impact on clinical trial design”, a Commentary published this week in Genome Medicine, discusses the effect current advances in genomic research have on the future of clinical trial design and on the interpretation of clinical trial data for disease management.
In their article, Dr Sumithra J Mandrekar and Dr Daniel J Sargent highlight milestones in genomic advances, such as the ability to develop genomic signatures for risk stratification of patients with various diseases and the development of biomarkers indicating how a particular patient might respond to treatment.
Although these advances have been hugely beneficial to medical research, their increased validity has given cause for a whole new way of designing clinical trials in future. For example, past clinical trials aiming to identify diagnostic markers of disease would select participants with certain risk factors for a particular disease and compare their diagnosis to a control group; the identification of genomic signatures, however, would significantly change the identity of risk factors in this trial methodology.
As is highlighted in this Commentary, we are entering an era of personalized medicine, and advances in genome medicine have provided researchers with a whole new set of tools for studying patient response to treatment; how these tools will best be incorporated into future trial design, however, remains to be seen.
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Commissioning/Development Editor, Genome Medicine