Clinical development is outmoded; we are witnessing serious attrition in cancer R&D. Perhaps it’s time to live and die by the mantra: “no biomarker, no trial”.
James Ritchie |
What is the biggest challenge that we face in our mission to bring new, effective medicines to patients? In my view, it’s attrition. In 2004, Kola and Landis reported that only one in 20 new chemical entities (NCEs) being developed for cancer make it to the market (1), with other indications faring somewhat better. A more recent analysis from 2014 suggests that this picture hasn’t really changed and, if anything, it has become worse (2). The success rate is frankly abysmal. So, what can we do to reduce attrition rates? What are the challenges and how do we overcome them? There is no quick, easy fix. We need a major transformation in the way we develop drugs, spanning preclinical development, how clinical trials are designed, and the way in which drugs are currently approved. It isn’t possible to cover every aspect here, but I’ll give you a few ideas to get you thinking.
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