The High Cost of Clinical Research – Who's To Blame And What Can Be Done?

By Ed Miseta, Chief Editor, Clinical Leader

Sergei Varshavsky, senior VP of global strategy for Synergy Research Group (SynRG), believes some of the greatest medicinal discoveries were done for a very low cost. He laments that this is no longer the case. Several factors have come together to drive the cost of new drug discovery to astronomical heights. 

Varshavsky discusses the reasons for the increase that lie with various groups, including the FDA, Big Pharma, and even CROs. Discussing the history of rising costs, alongside a chronology of FDA regulations, he offers reasons for the staggering increases in clinical reseacrh over the years, and gives his own recommendations for what needs to be done to stem the cost increases and bring much needed drugs to the world population. Often outspoken and controversial, Varshavsky does not hold back on pointing the finger of blame at those he finds to be responsible.

Excerpt from the article:

If the $4 billion figure is correct, that would represent an almost 4-fold increase just between the years 2005 and 2012. The numbers are equally frightening when looking at the new drug cost by manufacturer, which ranges from $11.79 billion for AstraZeneca to $3.61 billion for Amgen. Among the top 12 drug makers, the average is $6.19 billion. (Sources: InnoThink Center For Research In Biomedical Innovation; Thomson Reuters Fundamentals via FactSet Research Systems)

Varshavsky notes per-patient costs of trials are also on the rise. Between the years 2008 and 2011, the cost for a patient in a Phase 1 trial went from $15,000 to over $20,000. For Phase 2 that cost rose from $20,000 to $35,000, and for Phase 3 it rose from $25,000 to $47,000. The smallest increase occurred in Phase 4, where costs rose from $13,000 to $17,000. 

While Varshavsky puts some of the blame on regulations, he is quick to note that pharma companies and CROs must share some of the blame as well.