Much has been said of supply chain issues for tangible goods, such as oil, gas and food, but the uninterrupted flow of clinical trial data should be viewed as just as important. With vast quantities of resources being shipped around the globe daily, regional events – such as lockdowns in China, or sanctions on Russia and Belarus – have a global impact, and the ripples they create are wide-ranging. Moreover, globalisation often takes a hit when major events occur, resulting in regional trading blocs and near-shore sourcing of goods and components. Clinical trial placement is no different, with some companies pulling out of high-risk areas and delaying using recruiting sites in areas that may be at risk of, or have recently been home to, disruptive events. The emergence of COVID-19 was the biggest indicator of how global events impact clinical development. Phesi’s analysis of 300,000 global clinical trial sites showed that in the first two months of the pandemic, there was a 10% increase in site suspensions as a result of the lockdowns and associated disruption they caused. To activate a clinical development site typically costs in excess of $30,000 and can take as long as 100 days to become fully operational. The infrastructure and reopening costs associated with site closures – even if only temporary – can lead to permanent closure.

Looking at one of the most serious current events taking place, Phesi data shows that Ukraine and Russia are host to 2,911 recruiting investigator sites for pivotal trials (typically phase 3) – this is 4.4% of global sites contributing clinical development data. In any industry, loss of 4.4% of resource is significant, and clinical development is no different. The disruption or cancellation of a clinical trial can be devastating, resulting in lost money, time and timely delivery of treatments which could ultimately be life-changing for patients.
  
The findings highlight that trials into certain diseases are set to feel the disruption more than others; 26% of clinical trials in schizophrenia are based in Russia and Ukraine. As it is not safe to continue clinical development research here, this means that one-quarter of the projected data into new schizophrenia therapeutics is going to, at best, be significantly delayed or, at worst, lost completely.
  
Gastrointestinal diseases are also expected to be disproportionately impacted, including ulcerative colitis, for which 15% of global trial recruitment sites are in Russia or Ukraine, and Crohn’s Disease, where 12% of sites are in these countries.
   
In the longer term, Belarus and any other areas closely linked with the conflict are likely to be avoided as potential sites until the situation stabilises. Moreover, studies in areas such as neighbouring Poland, which is home to 1,738 (2.6%) of global recruitment sites, are also at risk. Supply chain disruption in clinical trials also leads to increased burden on other areas; the ripple effect caused by healthcare systems being burdened by refugees in nearby countries will also slow down the clinical development process as resources and medical staff are reallocated to more immediately urgent areas.
  
With many of the clinical trials taking place in Russia and Ukraine are in their final stage (phase 3), they have already received substantial time and investment, and some are even close to completion. What can be done to ensure that none of these efforts has been wasted, and can those trials approaching their endpoint be pushed over the finish line, in spite of the ongoing disruption?

To truly build a resilient clinical development industry and protect trials against external factors, clinical trial planning needs to methodically evaluate risks and develop plans to mitigate them. With more data than ever before at our fingertips, we can strategically design clinical trials. By leveraging data insights and predictive analytics to identify and select clinical trial recruitment sites, we must make sure that all eggs are not being kept in just one basket. By spreading recruitment sites over different countries wherever possible, not only are vital regulatory requirements being met, but the data produced during trials is also more reliable.
  
Moreover, by applying data, we can develop a new, best-practice resiliency culture in clinical trial design and management, which will allow sponsors to proactively protect their studies instead of scrambling to react in the face of disruption. By examining in real time where patients are, and which sites are already hosting trials, sponsors can identify alternative recruitment sites methodically and ahead of time. These built-in ‘safety nets’ will reduce delays when disruption does occur, meaning the development pathway is not completely broken and the time to market for life-changing therapies is kept to a minimum.

Data-led strategies will herald a new era of modern, future-proofed clinical trials by applying many of the learnings gained from the COVID-19 pandemic. The next generation of clinical trials will be patient-centred; prioritising digital interactions such as remote appointments, interactive and remote data collection.

‘The disruption or cancellation of a clinical trial can be devastating, resulting in lost money, time and timely delivery of treatments which could ultimately be life-changing for patients’

This strategy of decentralising trials has proven successful in the face of global crises, with remote data collection and teleconferencing essential in maintaining clinical trial activity during stay-at-home orders. But with restrictions relaxing, the industry is realising the potential of these modern techniques and incorporating them into trial design for many therapeutics.
  
Existing data and technologies including artificial intelligence will be central to building better clinical trials. From protocol and trial design to recruitment and management – and even using existing data to create synthetic trial arms, or digital twins that can replace control groups – data will be essential in supporting trials, relieving patient burden and filling in the gaps opened by major events. It is only by maximising the potential of the vast swathes of existing data that we can move toward a future of designing simpler, less amendment-prone trials. Not only will these trials be easier to execute, but they will also be less vulnerable to disruption.

Much has been learned from the past three years and the clinical trial industry will emerge stronger than before. By using big data to design and optimise trials based on similar trials that have already taken place, we can protect the clinical development industry against disruption, avoiding the expensive losses that can be caused by unforeseen circumstances and ensuring that trials are conducted expeditiously. Through this, we can ensure that trials are equitable and that new treatments get to patients as quickly as possible.
  
Major events shouldn’t be needed for us as an industry to adapt our processes to a changing world. By employing data to design more resilient trials we can, and should, continue to move towards a more resilient, data-driven clinical research process.