Clinical Genomics: The Impact of Genomic Technology on Clinical Trials and
Medical Practice assesses the challenges and future prospects for incorporating
genomics technologies into standard clinical practice. The report examines some
of the ways in which genomics could directly contribute to clinical practice,
evaluates the scientific, technological, legal, and regulatory issues that will
have a significant impact on the future adoption of genomics in clinical
settings, and discusses the emerging business opportunities that will arise as
the widespread application of genomics to clinical drug development,
diagnostics, and medical practice comes to fruition.
Recent events suggest that genomics may finally be poised to make a
significant contribution to clinical practice in the near future. In 2003, the
Human Genome Project completed the sequence of all human genetic material,
providing an essentially complete catalogue of all human genes. Since the
practice of genomics relies on large-scal e, comprehensive analyses of genes,
this information will prove very valuable in speeding the implementation of
genomics in clinical settings.
Furthermore, the U.S. federal government is emerging as a driving force for
the adoption of genomics in clinical settings. In 2003, two major U.S. federal
agencies issued reports indicating that implementation of genomics in the clinic
is of high priority. The National Institutes of Health (NIH) issued a vision
statement summarizing how genomics can contribute to the future of the practice
of medicine. The U.S. Food and Drug Administration (FDA) issued draft guidelines
for the submission of genomic data in drug applications, signifying a
potentially pivotal change in the use of genomics in drug development.
The clinical genomics environment is ripe with opportunities for all players
in the field—pharmaceutical companies, biotech firms, diagnostics
manufacturers, tool suppliers, and researchers—as the NIH and FDA make it
clear that increased use of genomics in the practice of medicine and drug
development is both anticipated and encouraged. Howe ver, clinical genomics is
far from widespread and still faces significant hurdles. Clinical Genomics: The
Impact of Genomic Technology on Clinical Trials and Medical Practice examine the
most important factors that will impact the transition towards more extensive
adoption of genomics technologies in clinical trials and medical practice. This
report offers critical strategic guidance to all companies participating in the
application of genomics to the prediction, detection, and diagnosis, and
treatment of disease.
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