Big Pharma’s gradual retreat on clinical trials in Russia

It’s been more than a month since the Ukraine war started, yet thousands of lives have been lost, millions have fled into neighbouring countries, and innumerable infrastructure destroyed. In terms of clinical trials, there’s been hesitation among pharma companies to react, particularly regarding Russia. Eventually, a notable number of them announced moves that could impact their pipelines and potentially the broader sector. Overall, these moves may potentially delay the delivery of new drugs.

Among the top 10 big pharma companies with the most ongoing clinical trials with recruitment sites in Russia, Bristol Myers Squibb (BMS), GlaxoSmithKline (GSK), Johnson & Johnson, MSD, Novartis, Novo Nordisk, Pfizer, and Roche noted that they have stopped enrollment of new trial participants in the country. BMS, GSK, Novartis, Novo Nordisk, and Pfizer also noted they have paused initiation of new trials in Russia. Roche added it won’t initiate new sites in the country.

An AstraZeneca spokesperson said the company has paused enrolment of new patients into existing studies in Ukraine and Russia and it is not starting any new clinical trials there at this time. It also does not have plans for new investment in Russia, he adds. Sanofi is continuing ongoing trials with Russian patients, although spending unrelated to medicines has been suspended. The top 10 is based on GlobalData’s clinical trial database.

Reasons for companies staying in or leaving Russia can vary. Departing companies have noted their exits were due to the Ukraine invasion. But also, it is now harder to keep connected with Russia with economic sanctions against the country, adds Dana Leff Niedzielska, co-founder and CEO of the CRO August Research. Likewise, the local healthcare infrastructure is closely tied to the state, she notes.

While these 10 companies have noted broad strategic decisions on their clinical trials in Russia, specifics are scarce. And identifying which specific clinical trials have exited or are likely to exit Russia is vital information for the broader clinical trials industry.

For starters, those exiting multicountry clinical trials may add recruitment pressure to non-Russia sites in the same trial, Niedzielska says. Big pharma companies may have to make imminent decisions as to whether to open more sites in already participating countries or in new countries altogether. All these decisions will eventually add up to addressing one big question: how to not delay market entry of new drugs or potential expansion of already approved drugs into new indications.

There is also the possible ripple effect to other clinical trials, in that more trials recruiting in the same countries may mean they would have to compete for the same patients. The rationale why these trials had sites in Russia in the first place is that it is a large country with many potential trial participants, and it could be challenging for certain countries to have to make up these lost trial participant numbers, Niedzielska adds.

A vast majority of clinical trials sponsored by big pharma with sites in Russia are in Phase III and are multicountry investigations, data reveals. Roche has the most Phase III clinical trials with sites in Russia (64 out of 79 trials), followed by Merck (59 out of 95) and AstraZeneca (54 out of 75).

There are only a handful of trials that were originally designed to only recruit from Russia, and all of them are currently in the planned stage, GlobalData shows. Novartis has five of these trials: a Phase III trial in lupus, a Phase II study in the prevention of graft-versus-host disease in blood cancer patients, a Phase II in pulmonary arterial hypertension, and two Phase I trials investigating cardiovascular disease assets. As for other big pharma companies, Roche has a Phase III haemophilia A trial, J&J has a Phase I butamirate citate study designed to enroll healthy participants, and GSK has a Phase II sotrovimab trial for Covid-19.

For any trial initially designed to recruit solely in Russia with currently no participants recruited, it may be more straightforward to restart a new trial submission to a new country altogether, Niedzielska notes. Perhaps unsurprisingly, multinational trial sites are mostly recruiting in other countries in Europe andNorth America, and to a relatively lesser capacity in Asia-Pacific and Central and South America.

Another finding from the big pharma data is that the clinical trials with sites in Russia are primarily recruiting for oncology trials, representing a total of 288 trials. Coming at a very distant second is central nervous system trials with 36 trials, and infectious disease trials at 34 studies.

While companies have announced their exit out of Russia as well as Ukraine and even Belarus, there have only been a handful of clinical trials that are specifically noted by industry sponsors as impacted by the invasion. Specifically, there are five clinical trials announced as disrupted and six other trials marked as potentially disrupted.

Out of all the trials disrupted, all but one are in Phase III. For the six potentially disrupted trials, three Phase III trials are sponsored by Intra-Cellular Therapies investigating lumateperone tosylate in major depressive disorder, and only one of these trials belong to one of the big pharma companies: AstraZeneca’s Phase II AZD1402 in asthma.