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Clinical trials in Russia: drug development pipeline at risk

Questions swirl on how sanctions against Russia might impact the drug development industry.

By Reynald Castañeda

Due to the ongoing invasion of Ukraine by Russia, many countries have imposed sanctions against Russia and private companies have pulled their services out of the country. But looking at the GlobalData clinical trials database, any noticeable trends in terms of change in clinical trial status are yet to emerge.

While a handful of companies have noted their clinical trials that are recruiting in Ukraine may encounter delays, industry sponsors with studies in Russia are yet to do so in the same capacity. Nonetheless, there seems to be a ripple effect carrying over to trials in Russia, with a clinical trial director at a top medical university telling Clinical Trials Arena their institute had paused recruitment of new patients in studies sponsored by overseas companies. Locally-sponsored trials are not affected so far, he added.

While the situation in Russia is still in flux, data shows the country is one of the key hosts for clinical trials. And if sanctions continue or escalate, it is also likely to have a negative impact on the global drug development pipeline. Clinical Trials Arena previously covered clinical trials in Ukraine, which you can read here.

One of top hosts to uncertain position

Russia ranks sixth among European countries, with Germany, the UK, Spain, France, and Italy on top of the list of countries with the most ongoing or planned clinical trials. Russia’s footprint in the clinical trials sector has increased over the years, wherein the number of trials jumped from 71 to 797 from 2017 to 2021.

The top therapy areas with an ongoing or planned clinical trial with at least one site in Russia are in the realm of oncology (561 trials), central nervous system disorders (310), infectious diseases (253), cardiovascular disease (228), and then gastrointestinal issues (168). Looking at companies sponsoring ongoing and planned Phase I-III trials in Russia, MSD (Merck in North America) (96 trials), Novartis (90), Roche (79), AstraZeneca (74), and Johnson & Johnson (59) top the list.

Russia is an attractive clinical trial destination due to its low-cost operations, centralised healthcare system, and a sizable population that allows for speedier recruitment. If Russia becomes an untenable clinical trial host, questions are likely to arise as to where these trials should relocate, and if the new country hosts would have enough patients or infrastructure to complete trial recruitment.

Many studies by overseas firms

Due to operational advantages, many industry sponsors with an overseas headquarters have looked to Russia to host their clinical trials. There are 125 US-based companies with 508 ongoing and planned clinical trials in Russia. Also, there are 134 companies based in Europe (excluding Russia) with 659 trials. On 25 February, Clinical Trials Arena reported of calls for the FDA to freeze any regulatory requests from Russia-based or -funded companies.

While any trend of clinical trial disruption in Russia is yet to emerge, international sponsors such as Intra-Cellular Therapies and Protagonist Therapeutics have started to acknowledge the risk to their trials and recruited patients due to events in the region.

Jounce Therapeutics, specifically, notes local tensions including Russia’s invasion of Ukraine, economic sanctions against Russia, its local businesses and the central bank, could disrupt or delay its ability to stage trials. And therefore, disruptions or delays could be expected, according to its Q4 earnings. Jounce’s 75-patient Phase II SELECT trial (NCT04549025) investigating its PD-1 inhibitor JTX-4014 in non-small cell lung cancer has 14 sites in Ukraine and 17 in Russia, with the rest of the sites located in neighbouring countries.  

Russia an attractive Phase I host

Russia has become one of the top hosts for ongoing and planned Phase I clinical trials due to many clinical trial sites specialising in early phase research. In fact, more than a quarter of the total ongoing and planned studies are in Phase I (502), second only to Phase III trials (911). 

Russia ranks third if European counties are sorted according to ongoing and planned Phase I trials, with the UK and Germany topping the list. But, if Russia-based companies were isolated from these numbers, it shows that a vast majority of these Phase I trials are sponsored by Russian firms. There are 339 Phase I trials sponsored by local companies versus 103 studies by companies in the US and other parts of Europe.

When these 103 trials are arranged by therapeutic area, the top five are in cardiovascular disease (37 trials), oncology (22), central nervous system (17), metabolic disorders (14), then women’s health (12). Some 81 of these trials are also scheduled to only recruit in Russia.

Planned trials at risk

Due to the uncertainty in the region, there are also questions if trials planned to start in Russia will in fact do so. Most of these industry-sponsored, planned trials are in Phase I (529 studies), followed by Phase III (185). That said, these planned trials are mostly sponsored by Russia-based firms, with only 177 studies sponsored by companies headquartered in the US or other parts of Europe.

Of the 177 planned trials, Pharmatechnology (12 trials), Berlin-Chemie (9), Richter Gedeon (9), Krka (8), and Novartis (8) top the list of sponsors. And when ranked according to therapeutic area, these trials are mostly on cardiovascular disease (40), central nervous system disorders (27), and infectious diseases (23).

Most concerning is that 122 of these 177 trials are only scheduled to recruit in Russia thus far. If sanctions were to remain or escalate, these trials could experience significant delays unless these companies quickly build redundancies elsewhere. Most of Russia’s innovation drug industry takes place in companies or institutions with government links.

Additional writing and data analysis by GlobalData analyst Priya Nair. Graphs by data journalist Ovanes Penchev

Merck in this article refers to MSD, which is the company name outside North America.

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