The UK has tightened regulation for clinical trials in recent years. Reaction from the industry has been strong, with some suggesting legislation and high costs will kill off research and development (R&D) innovation and clinical research in the UK – but there’s more to the issue than meets the eye.
Regulatory compliance is a challenge for all R&D organizations – particularly in developed nations with mature infrastructures and industries. But as British scientist Ben Goldacre recently pointed out, a ‘race to the bottom’ for lowered regulation and low-cost clinical trials is not a realistic ambition for countries like the UK. What is achievable, he explains, is a goal of leading the way in producing high-quality data.
This underpins a crucial truth in R&D: quantity and quality are needed in equal measure. Larger R&D firms have benefitted from economies of scale over the years, with greater volumes of research potentially producing greater commercial yields. But integrity and quality of data will always be just as important – and that starts long before clinical trials. Data integrity is crucial all along the drug development value chain – from discovery through to manufacturing and beyond. Thankfully, technology is now playing a central role in managing this and helping to create the all-important data value chain to support the business process value chain.
Organizations that lead the way on data quality leverage systems that allow scientists to manage and share data in its full context. They benefit from an accessible, searchable data trail that means the knowledge becomes an asset, not a by-product that fades over time. There has never been a more pressing need for firms to speed up the process of taking drugs from concept to patent and secure sources of truth will be vital in bridging that gap. This will only become more important as R&D continues to become an increasingly collaborative effort. If larger organizations are to act as research hubs, with a vast network of commercial and academic research stakeholders all feeding into discovery and development of new products, having the full picture – high-quality data in its full context – will prove critical.
Likewise, the debate over quality vs. quantity continues through to the registration of patents. They have often, understandably, been regarded as one of the most reliable yardsticks for measuring innovation in R&D. In particular, they have been referenced as evidence that Europe is falling behind the US and China in R&D innovation. But again, as I highlighted recently, quantity is only half the story. In a timely show of evidence for Goldacre’s comments, new figures suggest IP experts are concerned at the rise in low quality patents – particularly in the US and China, in comparison with Europe.
Clearly then, the UK and Europe are unlikely to lead on quantity in R&D – but they could lead on quality. That may be a tough pill for some to swallow, but the importance of data quality remains clear. Most interestingly of all, a more collaborative R&D landscape will surely see greater cooperation across continents – perhaps that is where a true balance of quantity and quality can really be struck.