The impact of war on patients and clinical research

After months of war, life for patients in Ukraine continues to get harder. The World Health Organization (WHO) has reported that people’s health has been imperilled by difficulty
in accessing emergency care and essential medicines.

Hans Henri Kluge, WHO regional director for Europe, noted that there had been more than 260 verified attacks on healthcare facilities in Ukraine by early June, resulting in some being destroyed and others struggling to cope with people who are seeking care for trauma and injuries.

The war has also made it extremely difficult for patients with chronic conditions, such as diabetes, to access the medicines they require. While pharmaceutical companies remain committed to ensuring patients everywhere receive life-saving medications, some have suspended operations in Russia for non-essential medications, which has the potential to further exacerbate supply chain bottlenecks.

Manufacturing and the supply of finished medicines, as well as raw materials in the region, has also been severely affected. Many insurance companies have implemented tougher requirements to cover Ukraine supply contracts, which has restricted cooperation with international suppliers. Fortunately, local manufacturers have been able to use their expertise to step in and negotiate new terms to ensure the supply of active pharmaceutical ingredients, excipients, packaging materials and other raw materials. However, managing the supply routes of medicines and raw materials in Ukraine has been challenging due to ongoing attacks and the closure of airports and seaports. In response, suppliers have had to respond quickly and make adjustments to routes.

The war has stopped many clinical trials in the region, with GlobalData’s Clinical Trials Database saying that by April 2022, eight phase 2 and phase 3 trials had been disrupted and another eight trials were in jeopardy as sponsors were forced to suspend enrolment in Russia and Ukraine. The impact is likely to be more extensive, with the US Food and Drug Administration noting that around 250 drugs and devices were undergoing clinical trials in Ukraine. Trials in Russia have also been impacted, with Moscow State Medical University noting that international pharmaceutical companies have halted recruitment of new patients to its 120 ongoing trials.

Mitigating the harm of war on patients
There are steps that sponsors and clinical research organisations can take to ease the crisis with clinical trials and, wherever possible, ensure patients keep participating. A priority should be to ensure ongoing follow-up with patients and doctors involved in the trial, do what they can to track where patients are located and, where possible, enable them to continue to participate in other parts of the world.

Clinical trial data should also be accessible via online channels, from when treatment starts to when it is completed, while also doing whatever is needed to prevent unblinding of participants. To achieve that objective, companies should put in place processes to safeguard that data, such as implementing data provenance, data privacy, traceability and auditability. Another important step will be to provide emergency contact details to patients who have been displaced by the war so they can get the care they need.

Experiences from previous wars do offer examples of mitigation steps that can help to ensure patients get the care they need. However, the most valuable lessons may be from the COVID-19 pandemic, which required companies to quickly pivot in order to ensure business continuity. In particular, technology and digital enablement came to the fore during the pandemic. Clinical trials increasingly became decentralised and healthcare providers turned to telehealth or digital health to connect with patients.

These innovative processes are now being used to provide virtual care to patients in need. As an example, the non-profit organisation Health Tech Without Borders (HTWB) was founded in 2022 in response to the war in Ukraine and acts as a hub to connect digital innovation with medical care. HTWB’s Ukraine Telehealth Relief aims to help hospitals cope with the rapid increase in patients, provide psychological help to those affected by the conflict and support Ukrainian refugees across Europe.

As providers and consultants in the healthcare industry, we are committed to using our expertise to help pharmaceutical clients, for example through the establishment of a network, or advisory alliance, across the industry, non-government organisations and healthcare providers to identify unmet needs, urgent priorities and solutions and recommendations to support patients in impacted regions.

For all of us in healthcare and the life sciences, mitigating the suffering of patients has to remain our primary concern.

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