Have You War-Proofed Your Clinical Trial Infrastructure?

Strategies for sustaining clinical operations during wartime.

The entire world underwent the COVID pandemic, and the clinical trials industry learned a lot about how to adapt to that situation, such as utilizing technology and decentralized operational methods to maintain clinical trial execution during the pandemic, to name a few. Nonetheless, after Russia invades Ukraine, economists predict a world war, and the US is losing its ground as the dominant global power. Other economists predict a civil war in the US. Despite wars, patients will always need therapies, and the biopharmaceutical industry must protect and maintain its clinical trial infrastructures to deliver much-needed medicines. This article will discuss why the west is facing the potential for wars, what happens during wars, and some strategies for sustaining clinical operations during wars.

Wars: The big picture

Let’s zoom out into a macroeconomic picture and explore what’s happening worldwide and in the US. I recently watched a shockingly disruptive but educational video posted by Hedge Fund billionaire Ray Dalio on world wars and the changing world order. It got me to think more about where the US is in its influence and power in the world versus growing competitive powers, such as China. Through financial and economic indicators, Dalio argues that the US is at a place where its power and greatness have peaked and is facing decline. For example, education investments have dropped significantly around the 1980s (and a reduction in innovation would inevitably actualize in 10-20 years from now), and the US has seen a consistent decrease in output, competitiveness and trade as seen in Figure 1 below.

Why is there so much internal turmoil in the US?

Internal turmoil and populism are arising from more considerable wealth disparities, as the few rich are becoming exceedingly wealthy compared to the majority of the poor. When there is only so much of the pie to split (i.e., country productivity and revenue), and the wealthy get a larger chunk of that compared to the poor, the poor view the system as unfair and attain populistic views. Additionally, the rich fund politicians to support their agendas, leading to more focused wealth and support (i.e., lower taxes and favorable changes in the political-legal structure to support the rich), further dividing wealth classes. Figure 2 below provides further insight into the timing of World War II in the late 30s when there was a wealth gap similar to the gap today and populism that arose during that time before the second world war.

In addition, during populistic times, the chances of civil war increase. Civil wars destabilize a nation’s productivity and provoke external rising powers to make military advances against declining powers. Essentially, the US is in this place because it spends (debt) more than it produces (income) and has made more frivolous than smart investments over the years.

Suppose we enter a civil or world war—how can you protect your clinical trial infrastructure?

While it is hard to believe, the United States is at an increased risk of facing both civil and external wars. Wars impose a horrific toll on countries and their economies; they are expensive and result in tremendous human suffering. While war may or may not occur soon, it is critical to prepare your clinical trial for one if the theory becomes a reality. Let’s discuss how wars can impact studies.

Target and build research infrastructure in stable global or local regions

During a world war, you are going to have countries that will forge allies (i.e., NATO with the West and China, Russia, North Korea in the East) and countries that sit on the sidelines and wait to see who’s winning the war, then ally with the winning side near the end of the war. Sideline countries tend to remain stable as they are not in the war path. Similarly, during civil wars, some local regions will be more stable than others. Countries and provincial regions that exhibit stability during a war are good places to invest and conduct research, so wisely predict your countries and local regions and invest in building research infrastructure there. An excellent early indicator is to look for countries that have abstained from voting against Russian sanctions. Those countries may be more likely to sit on the sidelines and remain stable during a war than those that have chosen a side.

Expect major disruptions—so, diversify by building global clinical trial infrastructure

The disruptions we’ve experienced during COVID may be similar to war, but war disruptions will have more enormous implications. For example, countries will impose economic sanctions, trade routes would be disrupted, and in countries under attack, power outages and danger to patients may outright halt your trial. Other areas to consider include investigational product manufacturing, raw materials and transportation, data collection disruptions, and regulatory authority backlogs. Furthermore, the potential for cyber threats and dormant cyberweapons targeted toward medical and clinical trial databases may exist and disrupt study sites’ electronic medical records, and biopharmaceutical clinical operations and data entry.

Invest in exploring countries and local regions and partner with GMP facilities that can manufacture investigational products and have protected trade routes with Eastern and Western countries or provincial regions; having access to multiple trade routes and relationships with these facilities that you can later activate, would minimize shipping disruptions to sites in stable countries and local regions.

Select study sites and build clinical trial infrastructure in stable countries and regions. For instance, I’ve done work in countries in Southeast Asia and South Asia and observed near-gold-standard clinical trial infrastructures; it may be worth reinforcing your clinical trial infrastructure in those countries and similar countries in different continents (i.e., Central Africa). This approach would diversify your clinical trial disruption risk.

Make it standard practice to use decentralized clinical trial (DCT) technologies. Wars will make conducting research at study sites difficult, especially in unstable countries. Asking a patient to come to a study visit at a site when imminent physical harm is present is unethical. Moreover, patient migration is inevitable. While cell phone and internet services may become spotty, DCT technologies would allow you to collect more data. Additionally, consider using data collection technologies that do not require a constant internet/data connection to submit their data (i.e., data collection on a local device that would upload when a network connection is established).

Validate technology companies (especially ones that hold your clinical trial data) that either have or are established on robust technology platforms that have (a) extensive cyber security protocols in place and (b) regularly update their software to protect against cyber-threats. For example, technology companies hosted on AWS or Google Cloud may be safer to use than those operating on a stand-alone database/environment. It would also be important to conduct cyber-security validations on study site health databases.

Summary

These perspectives are merely a few of many unanticipated issues during a time of war. The risks for internal (civil) and external (military) wars are rising, but, clinical trials must go on, and we must continue bringing therapies to patients despite the disruptions potential wars would present to clinical trials. Diversifying your clinical trial infrastructures and strategies can help your enterprise be more competitive and more likely to achieve its goals during warfare. Have a war plan.