Back to School 2016: Haste, not waste
24th BioCentury Back to School Issue: Revolutionize clinical development
As researchers in industry and academia rapidly unravel molecular disease mechanisms and drug developers become more adept at intervening in disease pathways with drugs targeted to specific populations, the current clinical development paradigm cannot keep pace.
The traditional staged model and frequentist approaches are too slow and uninformative to keep up with advances in biology, signals of exceptional efficacy in initial studies and changes in standard of care. To make matters worse, they do not use new and emerging knowledge to improve the odds of success or to benefit patient volunteers. ...