In March, the European Medicines Agency (EMA) released “Advice to Advice to sponsors on managing the impact of the war in Ukraine on clinical trials” where the EMA suggested using to lessons learnt during Covid-19 pandemic and apply the approaches as applicable. Further, in April, the EMA published a guidance “Points to consider on the impact of the war in Ukraine on methodological aspects of ongoing clinical trials” that highlights how the safety of study participants is of utmost importance and priority, and must be the driving factor of all decisions related to clinical trials.
The Russia-Ukraine war has undoubtedly affected millions of people in and around the world. Several industries have taken a huge hit where operational and business continuity has been threatened, pharmaceutical industry being one of them. From the delays along the drug development pipeline, to non-compliance products in the market being at risk, the industry faces several challenges that may ultimately affect healthcare around the world.
Russia and Ukraine are important partakers in clinical trials as they provide access to larger patient populations, highly experienced investigators, and state-of-the-art facilities. Moreover, the populations in the two countries are more representative of the American and/or European population. The USFDA requires the trial participants to be representatives of the U.S population for acceptance and approval of drug. Hence, Russia and Ukraine are widely included in EMA or USFDA regulated Phase 3 trials of drugs.
Out of all European countries with the most planned or on-going clinical trials Russia holds 6th place in ranking. Altogether, there are about 1100 ongoing and planned clinical trials undertaken by US or Europe based organization in Russia while clinicaltrials.gov lists more than 350 ongoing studies in Ukraine. Of these trials the top 3 therapy areas include oncology, central nervous system disorders, and infectious diseases. Added burden on healthcare system due to war, problematic logistics, loss of reliable data, and disrupted financial sanctions are some of the important factors that have put clinical trials on hold. Over 25% of American or European-sponsored trials, with a minimum of 1 site in Russia, are currently in Phase 1. Several private international organizations have revoked their services and have imposed sanctions which, if escalated, could impact drug development on a global scale.
These clinical trials could possibly be the last hope for some of the trial participants. Even if the war ends, initiating these trials may not be as easy as picking them up from where they were stopped, some of them requiring to be started completely again. Pharmaceutical companies developing drugs worldwide may shift their focus from Ukraine and Russia to other countries to ensure business and research continuity. Clinical trials sponsored by industry may have to recruit participants from elsewhere as geopolitical tensions seem unlikely to resolve. Many clinical trial participants with diseases pertaining to these and other therapeutic areas have fled Ukraine and therefore need continued treatment in the countries they have taken refuge in. This is tragic as many patients are facing disruption in their treatment, and trials are unable to conduct follow-ups to achieve relevant patient safety data that could affect healthcare around the globe. There is no doubt that clinical trials are lengthy and expensive and disruption or pause in the clinical trials will not only lead to delay in availability of new treatments, butalso have substantial ramifications in the financial aspects of the drug development.
At present, no new clinical trials will be conducted, nor will new recruitment procedures take place. Evacuation plans are being established to ensure patient safety before anything else. The repercussions of this geopolitical conflict on the pharmaceutical industry are yet to be measured. Some global drug organizations have withdrawn their services from Russia and delays in on-going clinical trials is inevitable. CRO’s have closely been monitoring the situation at the sites in these regions and are committed towards facilitating the continuity of on-going trials while prioritizing employee and patient safety. Meanwhile, many pharmaceutical organizations have donated millions of dollars to support humanitarian efforts in Ukraine. Several uncertainties remain and at this point it is difficult to say when normality will be resumed. But one thing is for certain… Russia’s one political move has left a substantial mark on the entire world in more ways than one.
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