ABSTRACT
Introduction In the dynamic world of clinical research, any written work spotlighting the latest developments involved in funding and resourcing the trials of potential new medications is likely to be a bit outdated on the day it is published. Indeed, there were several significant news items that should affect the nature of clinical development between the time this chapter was started and the date it was submitted for publication. Nonetheless, this chapter presents some thoughts on several areas in which tomorrow’s clinical trials are likely to be different from yesterday’s. At the outset, it is important to note the recent (and ongoing) initiation of several long-term strategic partnerships between drug sponsors and contract research organizations (CROs). These arrangements are fundamentally changing the relationship between those two parties, since many of them call for the sponsor to transfer unprecedented amounts of operating and resourcing risk to their CRO partner(s). In turn, those CROs are assuming more autonomy and responsibility for conducting trials. In light of that new answerability, they are beginning to play a more proactive role in transforming clinical research. Several implications of this evolving relationship between sponsors and service providers are noted throughout
Introduction ...................................................................................................... 49 Funding clinical research ................................................................................ 50 High costs of recruiting clinical trial patients .............................................. 54 Complexity of clinical trials ............................................................................ 58 Executing trials more efficiently and effectively ......................................... 59
Maximize value of outsourcing firms ...................................................... 61 Take advantage of FDA initiatives ............................................................ 62 Pursue more “disruptive innovations” .................................................... 63
this chapter. Perhaps the most important is the changing motivation of both parties to address some historic bottlenecks in clinical research, thereby making the process both more efficient (very possible) and more effective (more challenging).
