As the dust settles on a turbulent 12 months, PRISYM ID’s Chief Executive Richard Adams explores the potential for an exciting legacy for clinical trials management to emerge from the pandemic – and explains why we must be ready to grasp it.
In the last fifteen months both individuals and organizations have had to change their behaviors. It’s typically meant more activity being done remotely, requiring greater agility and pace to deliver against changing demand, with technology often being deployed to overcome the unique challenges the pandemic has posed.
Clinical trials are no exception – in fact, being at the forefront of our pandemic response from the outset, you could argue that this pressure to change and rethink old orthodoxies has been even more intense. I recently wrote about some of the big shifts in practice we’ve seen as a result in International Clinical Trials Magazine.
Briefly, these include:
- the introduction of faster, more flexible logistics processes, including on-demand and JIT models;
- an increasing shift towards direct-to-patient /virtual delivery models, supported by remote monitoring technology;
- a recognition that having resilient and flexible global supply chain management processes are an essential part of a pandemic response; and
- a specific interest in the role that global label management and automated inspection solutions can play in supporting this.
Yet reflecting on these developments and the extraordinary achievements they’ve helped to bring about; three things strike me as particularly important.
The first is that all these shifts actually pick up on pre-existing trends in clinical trial management: in other words, the pandemic appears to have accelerated the evolution of the clinical trials landscape rather than revolutionizing it. What’s new has been the scale and pace of the adoption of these new practices – which raises the question about how or whether this progress can be sustained.
The second is that the pandemic has lifted the veil on what can be achieved when all restraints are removed. The context has obviously been a unique one, but the means by which supply chains were optimized to fast-track vaccine development can surely be applied universally to improve processes for other drugs. The pressure to replicate and standardize these practices going forward will be significant – this is something Steve Ellison explored with our client RxSource in our recent webinar describing their work with us.
The third and perhaps most important point is that the progress we’ve seen in accelerating clinical trials processes has a profound human and moral significance. Operationalizing a vaccine response within a year is more than just a smart bit of enterprise; its impact is already being linked to saving hundreds of thousands of lives and, if early signs from those countries that have made the most progress are representative, this should start to allow us to see our friends and family in person, to hug our grandchildren and to return to life as normal.
The potential patient benefits of these improvements to the clinical development landscape are enormous – but so too are the challenges of sustaining this progress. To give one example, recent Oracle research shows 76% of respondents said at least some trials have already been decentralized and 38% said more than half are decentralized – but many also expressed serious concerns about data collection and quality, as well as challenges around regulatory guidance.
My feeling is that we owe it to patients to do everything in our power to learn the lessons of the pandemic, and to strain every sinew in seeking to apply the same speed, ingenuity and resourcefulness to bring other life-saving medicines and devices to market sooner.
*Reference to Oracle Report