Vladimir Putin’s invasion of Ukraine forced governments and private companies to retaliate by breaking the industry with Russia. decades. “
One of the ramifications of the end of globalization caused by ukraine’s infrastructure devastation, loss of human life, the resulting housing crisis, and the resulting global isolation from Russia is a reduction in the ability of pharmaceutical corporations to promote promising drug candidates. clinical trials of drugs that are ready to be announced to U. S. consumers. The U. S. Centers for Disease Control and Prevention come with U. S. sites, several times the majority of the thousands of clinical trial participants in global Phase 3 trials designed to demonstrate the protection and efficacy of a drug candidate enrolled in the clinical trial. USA Two countries that have been the main participants of patients enrolled in global clinical trials are Ukraine and Russia.
Clinical sites in Ukraine and Russia are popular for global trials designed to bring drugs to the US market for several reasons. First, the populations of Ukraine and Russia are sometimes more representative of the US population in terms of race and ethnicity (majority of the population is Caucasian in each country) compared to other populous countries. (for example, China or India). The US FDA requires that a drug application come with studies of this drug in a population considered representative of the US population, and therefore sites from those two countries have been included. routinely in global phase trials. 3 of drugs intended for sale in the United States. The FDA takes this requirement seriously; in February, for example, the FDA rejected an application through Eli Lilly and Innovent for approval of a drug based on a positive phase 3 clinical trial that exclusively recruited Chinese breast cancer patients. lung, a population that was not considered representative of the US target population (see my February 2022 blog post on this topic).
Secondly, clinical trial sites in Ukraine and Russia are very popular because the sites there attract patients temporarily. Therefore, pharmaceutical trials are highly sought after by patients in those countries, as enrollment in a trial can allow the patient to gain advantages from remedies that are folk remedies for U. S. patients. USA Therefore, sites in Ukraine and Russia can constitute a significant number of clinical trial participants in global trials. A review of clincialtrials. gov, which lists ongoing trials around the world, indicated that lately 375 trials are enrolling patients in Ukraine, 231 of which are phase 3 trials designed to approve a drug, sponsored to the maximum by the US. U. S. pharmaceutical corporations. Similarly, 961 trials are enrolling patients in Russia lately, of which 434 are phase 3 trials. Many of those phase 3 trials are indexed as patients who are newly enrolled in Ukraine and Russia, that is, before the Russian invasion.
Not surprisingly, one of my colleagues who visited Germany after the Russian invasion pointed out firsthand that a large number of participants in cancer clinical trials have fled Ukraine and want continued treatment in a clinic in some other country. This dynamic represents a non-public tragedy for the individual patient whose treatment was permanently discontinued or stopped and which also potentially corrupts the entire trial, as enrolled patients are at the highest risk of being permanently lost during follow-up and not being available to measure the effects of drug treatment. under study
The challenge also affects corporations that make clinical trial plans that have based their directory projections on a significant contribution from sites in Ukraine and Russia, neither of which are viable features at this time or most likely in the near future. The result is a delay in carrying out the verification and, in all likelihood, a total cancellation of the verification if the suitable replacement sites cannot be known within budget. Since clinical trial sites in Ukraine and Russia have lower fees than U. S. sites. In the U. S. , those budget considerations can be significant.
One of the consequences of those global events could be the “relocation” of clinical trials to the United States. This could help the pharmaceutical industry access U. S. patients more effectively, as most eligible clinical trial participants are not yet enrolled in the corresponding clinical trials. , and this reflects a lack of awareness rather than the patient’s choice not to participate.