Does it work? Once upon a time it was sufficient to determine if a drug, diagnostic or device delivered some benefit.
A significant effect in a randomized, placebo-controlled trial was necessary and sufficient to identify efficacy. Combined with demonstration of safety, this was enough to garner regulatory approval and with it a sizeable profit. But not any more. Today, the key question is “Does it work well enough?” If the simpler question of whether it works at all was hard enough to answer, often necessitating expensive and time-consuming trials, it was a stroll in the park compared to the questions today’s healthcare executives and entrepreneurs are facing. It is an order of magnitude more difficult to determine whether a product works “well enough”.
The first challenge is determining how good is good enough. The frameworks by which such a decision is made vary geographically, and not just in small or inconsequential ways. More
RxCelerate Ltd is an outsourced drug development platform based near Cambridge, UK. We specialize in delivering an entire road map of drug development services from discovery and medicinal chemistry through to formal preclinical development and clinical up to Phase IIa. In the last five years, we have witnessed dramatic changes in the drug development …