ABSTRACT
It is recognized that in the past decade the increasing spending on biomedical research does not reflect an increase in the success rate of pharmaceutical development. Woodcock (2004) pointed out that the causes of the situation include (1) a diminished margin for improvement that escalates the level of difficulty in proving drug benefits, (2) genomics and other new science have not yet reached their full potential, (3) mergers and other business arrangements have decreased candidates, (4) easy targets are the focus as chronic diseases are harder to study, (5) failure rates have not improved, and (6) rapidly escalating costs and complexity decrease willingness/ability to bring many candidates forward into the clinic. As the low success rate may be due to an inefficient go/no-go decision process based on limited (or insufficient) information available from studies conducted in early phase clinical development, it is suggested that from bench-to-bedside translational research such as biomarker studies and genomic-guide clinical studies be conducted in the early phase of pharmaceutical development with rigorous scientific/ statistical justification to increase the probability of success of the development of the drug product under investigation.
