Strategic Allocation of Global Clinical Trials
Challenge: The selection of where to place patient recruitment sites of clinical trials is a critical strategic decision for developers of drugs and biologics. Such complex decision making is becoming increasingly important as companies move towards the global concomitant registration model, in which the information generated in a global clinical development program allows simultaneous access to the new medication in multiple markets across the globe.
The allocation of global clinical trials depends on numerous factors, including: characteristics of the patient population; clinical research infrastructure; costs; market potential of individual countries; patient recruitment speed and compliance; local regulatory requirements; business environment; local standards of care; and engagement of key opinion leaders.
The relative importance of each of these factors is expected to vary according to the condition being studied. For some diseases, access to patients may be the most important factor, while for other conditions that require more complex trial design and/or long term follow-up, clinical research infrastructure may be the critical factor.
- Characterize the allocation decisions made by planners of global trials on serious and/or life-threatening conditions
- Identify the critical drivers of allocation decisions for each condition through focused interviews with planners of pivotal global trials and analysis of business intelligence related to clinical research
- Characterize the competitiveness of individual countries in attracting trials on each condition, with comparative analysis of major traditional and emerging nations.
Publications to Date:
- Thiers, FA; Sinskey AJ; Berndt ER. Trends in the Globalization of Clinical Trials. Nature Reviews: Drug Discovery, 7(1): 13-14. January 2008.
- Thiers, FA. The Globalization of Clinical Drug Development. Science Masters Thesis, Harvard-MIT Division of Health Sciences and Technology, Cambridge, MA. June 2006.
Principal Investigator and Co-Director: Ernst Berndt, PhD, Louis E. Seley Prof. of Applied Economics, MIT
Co-Director: Fabio Thiers, MD, PhD, Visiting Scientist, MIT