Clinical supplies & logistics
securing dynamic third-party vendors, there’s plenty trial conveners can do to keep prices down. That is, of course, if they get to grips with the technology needed to bolster efficiencies – and tackle the data security issues that follow close behind.
Paying the price
Beyond the headline statistics, experts have been flagging rising clinical trial costs for years. If Anderson is one example here, Salman Shah is another. A clinical research expert at EY, he suggests that “if you look at the curve” clinical trials have been getting more expensive for around two decades. Perhaps inevitably, meanwhile, Shah warns that the pandemic has exacerbated the situation too. As he puts it: “The installation costs – labour costs – played a significant role in recent years.” That’s not hard to appreciate: with lockdowns and social distancing, trial conveners had to rush to embrace new trial models, which in the short term is bound to raise expenses. In truth, though, the current trend for pricey trials runs much deeper. That plausibly begins with personnel. Whether due to residual pandemic fears, regulatory hurdles, or else the need to secure subjects from specific populations, Anderson says that patient recruitment can “often be a lengthy and costly process”. Certainly, statistics support this claim, with work by Parexel finding that 80% of trials are stymied by a lack of manpower. That’s echoed, Anderson continues, by the increased sophistication of studies themselves. For one thing, personalised and sensitive treatments like cell therapy are bigger-budget drugs than generic alternatives. For another, wearables and connected devices, though inevitable from a data perspective, are necessarily pricey too. Ironically, though, arguably the biggest pressure point for trial accountants isn’t directly in their control. There are two ways of thinking about this. One involves comparator drugs, the medicines against which a new medicine is tested. As so often, the research here speaks for itself, with the global comparator sourcing market predicted to hit the $1.3bn mark by 2031. And if that means conveners need to take out their wallets ever more frequently, it can be just painful to manufacture investigational products (IPs) themselves, let alone ship them to the patients who need them. As Anderson’s warning about scaled-back trials implies, moreover, the impact of unequal balance sheets is increasingly shaping clinics around the world. From a medical perspective, that’s necessarily most worrisome for patients. “A lot of these therapies are usually last-resort for patients – especially in cancer,” emphasises Shah. “And if we can get it to them, there’s hope to elongate their lives, which has a huge meaning behind it.” And though rather less important from a humanitarian perspective, fewer
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drugs to sell naturally feeds back into the finances of pharma companies too, with delays of over a month costing $8m each and every day.
Fewer costs, more benefits How can sector insiders begin to make trials more economical? Given how vast the outlay can be, it’s unsurprising that many companies are focusing on comparators. In the first instance, that means honing third-party relationships, ultimately making crucial drugs cheaper to source. A good example involves AstraZeneca, which partners with Essex-based ADAllen to secure test drugs quickly and efficiently. Across the Channel, at its Centre of Excellence in the Swiss town of Luzern, Merck has a dedicated team to pick comparator vendors – as well as manage supply chains and understand trial timelines.
Rising costs in clinical trials lead to fewer new drugs being brought to market, but technological innovations offer hope for reducing expenses.
“We are seeing biopharma clients having to cut costs and reduce the size and prioritise their drug development pipelines.”
Dawn Anderson
Of course, it’s all well and good relying on external expertise here. But as Anderson stresses, that doesn’t solve the issue of getting comparators (and IPs) to where they’re needed, something that in practice can be achieved through the immense power of technology. As she puts it: “We are seeing a focus on driving automation solution and predictive analytics to be able
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