ABSTRACT
Discovery of biomarkers* and the evaluation of their reliability for assessing
candidate therapies is a multifaceted process that integrates many disciplines,
technologies, strategies, and resources. Successful use of biomarkers in the
development of therapies for HIV/AIDS, cancer, cardiovascular disease, and
degenerative bone disease has heightened interest for their use in research. The
potential use of biomarkers as surrogate endpoints† in clinical trials has also been
recognized. Recently, efforts have been made to coordinate and streamline
biomarker research through collaborations and partnerships among a variety of
biomedical research and development (R&D) organizations, including
academic biomedical research institutions, commercial R&D organizations
(pharmaceutical and biotechnology companies), federal government biomedical
research and regulatory agencies, and voluntary, not-for-profit health advocacy
foundations. The rationale for encouraging partnerships in biomarker research
includes the complex and rapidly changing clinical research environment,
the high level of complexity of the diseases investigated, a substantial increase in
the number of candidate therapies to be evaluated, finite fiscal resources to
support rising costs of therapeutic R&D, and the lack of high-precision clinical
technologies to assess novel therapies in clinical trials.
