What steps can clinical development organizations take to mitigate the risks after the war in Ukraine?

Date: 04. 01. 2022

 

We all hope that the war in Ukraine will end as soon as possible, but there is no denying that its impact will be long-lasting. The clinical development industry in particular will take some time to recover. Although the war is happening in a single country, the effect on clinical development is global. What can sponsors do to keep the development of new treatments moving forward?

Derailing development

Ukraine and Russia are important countries for clinical trial patient enrolment. Phesi’s latest global data analysis conducted March 16th found there were 65,593 recruiting investigator sites globally involved in pivotal trials. Of these, 2,911 (4.4%) investigator sites are based in Ukraine and Russia – and are now either cancelled or on hold as a result of the conflict. A further 1,738 sites in neighboring Poland are also at increased risk as a result of the war.

The number of sites impacted by the war means this is not just an issue for the clinical development community, but also for patients. Certain diseases are more affected by the conflict than others. Phesi’s analysis found that more than a quarter (26%) of all trials in Schizophrenia take place in Russia and Ukraine. In addition, a high proportion of gastrointestinal diseases – including 14% of Ulcerative Colitis trials, and 10% of Crohn’s Disease trials – also take place in Russia and Ukraine and are therefore threatened by the conflict.

Sadly, we can reasonably assume that given the scale of the war and as the pharmaceutical and healthcare sectors in Ukraine redirect their resources to urgent needs, it is unlikely that trials in Ukraine will get back up and running in the short term. At present, it is important to prioritize the safety of investigator site staff and patients in the country before we think about it reassuming its role as a critical location for trials.

For now, trial recruitment in these countries should be stopped, and sponsors should also look at how disruption to trials can be minimized by leveraging existing and synthetic data. Some sites will have to be replaced by sites in other countries. Some trials can be kept going virtually and remotely as part of a decentralized approach. Supplementing trial data with synthetic data based on real-world patient data from historic trials. This can fill knowledge gaps during this time of crisis – ultimately helping to get urgently needed treatments to patients.

Getting back up and running

Keeping lines of communication open with investigators, academics, CROs, and regulators will put the clinical development industry in the best position to collaborate post-conflict.

It will take time before clinical development in the region gets back on its feet, the global community must take steps now to ensure that it is prepared for when trials pick back up. Retaining links with key personnel and looking at how synthetic data can help to close knowledge gaps will be essential to helping the region recover as quickly as possible.

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