In The Context Of Rising Clinical Trial Expenses, As A Result Of Increased Patient Numbers And Extended Time Frames, What Clinical Development Design Innovations Will We Observe In The Next Two To Five Years?

A: CLINICAL RESEARCH, AS A FOR-PROFIT ENTERPRISE, FOLLOWS SUPPLY-AND-DEMAND RULES OF THE MARKET ECONOMY: huge demand + short supply = higher prices for site service. There are some 1,000 new compounds in clinical development in the U.S. alone, and sponsors desire to use relatively few clinical “centers of excellence.” This is tragic, as there is a huge oversupply of eligible cancer patients, but they cannot be accommodated by just a few centers. The cost will continue to rise until dynamic changes are made, such as by monitoring patients in trials digitally or without (or with limited) engagement of sites. Trial design needs to be more driven by common sense. This seems to be such a simple, yet unachievable, “innovation.”

TOMASZ SABLINSKI, M.D., PH.D., is the cofounder and board member of Transparency Life Sciences.