2018: Grappling with Brexit
At the close of 2018, Brexit continues to roil the pharma world (and beyond), presenting challenges to how clinical trials are designed, placed and conducted. Movement of investigational and finished medical products in and out of England, movement of personnel across borders, tariffs and more all threaten to negatively impact the global competitiveness of the UK.
We talked with an array of stakeholders this year and despite the shifting political landscape, one thing is clear: the UK can take concrete steps to advance clinical research and be more competitive, regardless of how the separation unfolds.
In November, we collaborated with ACRO member companies to develop six policy recommendations that rethink and optimize how clinical research is done, in part as a way of counterbalancing what are likely to be disincentives for clinical research in the UK post-Brexit.
ACRO made policy proposals around centralized contracting and ethics review procedures, the “right to write” potential trial participants, modernizing data access policies, prioritizing trials within the existing healthcare system and supporting investments in high-throughput research facilities.
Already these concepts are gaining traction, with new digital initiatives and an updated Life Sciences Sector Deal, making for positive prospects for UK clinical research in the coming year.
2019: Thinking Digitally
But new strategies for boosting competitiveness won’t be restricted to the UK in 2019. Amidst industry-wide pressures for greater efficiency, clinical research organizations will be looking to not only extend their investments in innovative technology and processes, but to more clearly demonstrate their value and how they are sparking change.
From RBM to virtual trials, from eConsent to AI, 2019 will see digital technologies continue to transform how we conduct clinical trials. Labs and sites, research organizations and sponsors are all shifting away from a paper-based world and learning important – if sometimes difficult – lessons along the way.
Growing use of these new tools is enabling us to rethink what’s possible and do more for patients. But we can’t keep that knowledge to ourselves – learning shouldn’t just be for machines. The clinical research industry needs to increase its efforts to educate all our stakeholders – including sites, sponsors, IRBs and, not least, regulators - about our constant innovation, how far we’ve come and how our industry’s digitization is shaping an exciting future.
In 2019, clinical research organizations need to build closer relationships with regulators and policy makers, to better demonstrate how we make clinical research smarter, faster and cheaper and the implications for health systems and patients.
The shift to increased digitization also requires careful examination of data standards and interoperability, how privacy is protected, and what this new digital environment means for the conduct of trials in a globalized world.
In order to have those discussions, we need to do more to inform – we must find new ways to tell stories of change and impact. Consider it to be our industry’s internal form of Real World Evidence.
A broader, better understanding of the digital health landscape helps us to collaborate more effectively and grapple with the new challenges presented by ongoing digital transformation.