CLINICAL STUDIES - WHAT YOU DON'T KNOW WILL HURT YOU! AUSTRALIAN BIOTECH - 'IN THE KNOW' WITH CLINICAL TRIALS?

Clinical research is the most expensive and longest phase of drug development. A loss of one million dollars (US) is incurred for every day of delay in developing a successful drug. Therefore, clinical trials must be conducted efficiently to optimise drug development. Data from the US, however, indicates that timelines for clinical trials of biopharmaceuticals have become progressively worse. In contrast, the timelines for clinical trials of new chemical entities have become progressively better. While relatively few Australian biotechnology companies have advanced compounds to the clinical trial stage, companies will need to develop strategies to ensure clinical trials are conducted efficiently. Australian biotech companies need to focus on planning, processes, people and partners and may benefit from lessons learned by large pharmaceutical companies ('Big Pharma').