Billions are spent discovering new medicines every year – even with the knowledge that most projects (and even many vastly expensive Phase 3 trials) will fail. But the aim is noble, the prize for success high, and despite debatable return on capital, pharmaceutical R&D has grown exponentially over the last three decades.
The presumption behind this is that we need new medicines to improve clinical outcomes for patients. This, in turn, assumes that we make something approaching the best use of the medicine cabinet we already have.
Is there any evidence that we do that? After all, clinical trial evidence addresses only very narrow questions – did a particular group of patients do better when treated with a drug compared to standard of care, for example. But that provides no information about whether the group that should receive the drug should be bigger, smaller or altogether different, either from a clinical outcome perspective or a cost-effectiveness perspective.
Even the added layer of cost-effectiveness assessment added by bodies such as NICE and IQWIG in Europe or the payors in the US asks a broader question only in so far as it compares different medicines with the focus on cost to benefit, but it can still only work with the available clinical trial evidence.
The problem is simple: complexity. Treating any disease is a complex process. And complex means more than just difficult to understand: complex is also a technical term for a system whose behavior cannot be predicted from the behavior of its sub-processes. In other words, you cannot work out the best way to treat people with a particular disease by optimizing individually the diagnostic and therapeutic components of that treatment.
Put simply, the reductionist approach of clinical trials means we have, for the most part, no idea how efficiently we use the medicines we already have.
“There is a presumption that no ‘mere mathematician’ armed with the same computer models that revolutionized financial markets and manufacturing industries alike could possibly know better than even a humble primary care physician as to how to treat your grandmother”
And when we dig a little deeper, the information that is available suggests precisely the opposite. That we are strikingly inefficient at using the tools available today from both and outcome and cost perspective.
DrugBaron draws a parallel between the complexity of the human organism and that of the healthcare system, and asks whether the tools of systems biology could and should be applied to healthcare delivery. The results from such a paradigm shift could be dramatically improved clinical outcomes from a lower healthcare …
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 …