Reducing the time to market for new drugs by managing clinical trial technology and workflow.

摘要

Clinical trial technology is the application of information technology to the automation of practical processes in clinical development activities. Workflow reengineering has been a dominant movement in many manufacturing industries in the last two decades. The pharmaceutical companies do not broadly recognize the integration of workflow reengineering with clinical trial technology. Although this phenomenon is interdisciplinary, its internal structure and the nature of its interactions with other disciplines in clinical development organizations have not been studied in depth. This research analyzed the empirical data based on descriptive statistics and on performing variability testing as well as correlation and predictive analysis. Four major constructs were investigated to test the premise that pharmaceutical companies, which integrate their clinical trial technology with workflow engineering by integrating processes into overall clinical development methods will show a reduction in time to market for new drugs. Seventy-seven parent pharmaceutical companies were surveyed for this research. Historical review of the 2001 corporate filings extracted and paired with the survey results were used to predict the implications for financial performance of reducing clinical trial delays and elapsed time. Annual based longitudinal research and further studies of the associated measurement of cost components are needed.