Although Eastern Europe offers challenges, it is increasingly being viewed as an attractive region to outsource clinical research to, as ClinStar’s David Passov tells Andrew Tunnicliffe.
Political and social reforms across parts of Europe in the late 1980s and early 1990s changed the face of the continent. The fall of the Berlin Wall, which had stood for almost 40 years, symbolising two very different ideologies, marked a new chapter for Europe with the fall of the iron curtain and break-up of the USSR.
When President Mikhail Gorbachev came to power in 1985, he knew if the USSR were to survive it needed to modernise. He believed that if communism were to continue to be accepted by the Soviet people, then political, and more importantly economic, reforms were essential. More than two decades on, those reforms remain a work in progress with considerable distance still to travel.
Russia, Ukraine and their neighbours are still seen within the context of Eastern Europe’s emerging markets. Further economic reforms are needed and the politics of the region remain shrouded in suspicion and corruption, leading many to think twice before investing. But, says David Passov, president and CEO of clinical research organisation (CRO) ClinStar, any concerns about political instability are misguided.
He says that in spite of the concerns some from the West may have about investing in the region, there are no big surprises about Russia and its politics. "You know the players; you know they’re interested in foreign investment and they’re not going to jeopardise that," he says. "You may question the democratic values, but you can’t question the stability."
Russia: a multiethnic nation
ClinStar, a US-based CRO has a history of working in emerging markets and was one of the first to undertake clinical trials in Russia. Passov believes there are other misconceptions about the region that need challenging. One is its, and in particular Russia’s, ethnic mix.
"Russia has nine or even 11 time zones," he says. "It’s a massive country with 145 million people, spanning Europe and Asia, so it provides a pretty interesting ethnic mix… I think that sometimes the criticism of Russia is that the population may not be similar enough to Western Europe or the US and that the [clinical trial] data may not be accepted because the population is different. I disagree because the US is a multiethnic nation, and when you conduct clinical trials in the US, who are the subjects? There are different people, different backgrounds, cultures, diets and ethnic groups. The same is true of Russia; there is a vast diversity, so the populations, in my view, are actually more similar than they are different."
There are many reasons Russia should be seen as a place to conduct clinical research. Not least because regulations introduced in September 2010, as part of a wider revamp of healthcare and medicinal products legislation, require that any drug being commercialised within the country has to have had some of the data used in approval generated there. However, says Passov, this requirement lacks clarity leaving many to question how they are going to adhere to it. There is speculation that the recent election and appointment of a new minister of health will lead to this part of the regulation being changed or dropped altogether. A benefit to carrying out part of a trial in Russia, or any country for that matter, Passov suggests, is the opportunity to find thought leaders.
"A good way to generate thought leaders for your product is to involve physicians in your clinical programmes; get them familiar with your product and have them be your first line champion when it becomes available for prescribing," he says.
Fall and rise in number of clinical trials
The region, however, has struggled in recent years to shake off the hangover from the global financial crisis.
"In 2007, the number of newly approved international clinical trials in Russia was around 360. Then, in 2008-09, there was a slow decline before things dropped to about 250 in 2010," Passov says. The drop can be attributed to a couple of factors, he continues: "One was the crisis in the industry in general. At the end of 2008 and beginning of 2009 the overall volume of global clinical trials decreased, because the number of products being developed had decreased and this carried over to Russia. Because international or Western companies develop most of the innovative medicines, there are fewer clinical trials in Russia." Things have bounced back in 2011, with the number of new approvals back to 2007 levels. But, warns Passov, with Europe still in financial turmoil there may continue to be some effect on the overall number of clinical trials.
To counter the tough economy and in a move intended to lift the profile of the domestic pharmaceutical industry, Russia’s political elite announced a multibillion-dollar initiative to increase the size of the domestic market and resurrect it from the death of the communist era.
Today, Russia’s pharmaceutical industry comprises a vast pool of generics manufacturers with very few organisations looking to develop innovative therapeutics in spite of government efforts. In fact, most innovation is imported by Western pharma and biotech companies.
And it is this that should appeal to Western pharma, believes Passov. "Clearly any biotech or pharma company that wants to bring their product to market is looking at the US. But Russia has a socialised medical system and many products are covered by the government. There is also a big culture for out-of-pocket spend on medicines." It is because of these factors, and the requirement to provide some data produced in the country, that Western pharmaceutical companies are looking at Russia as a base for some of their clinical research.
Growth in CROs
In the region today, there are three types of CROs: the big global ones with offices in Russia; small local players who may have one or two trials; and the well-established, geographically focused CROs, which are sizable, with wide reach in the region and good quality systems in place.
The growth in CROs has been led, primarily, by the reduced costs the region offers in clinical research. "Depending on company, size of study and location, the cost is certainly lower," Passov says. "The question is whether it’s ten or 30% lower. And investigator fees can be anywhere from ten to 30%, or even 40% lower… but I think the biggest cost savings actually come from the ability to enrol patients faster and as such complete your studies sooner. By including Russia, you can close your study earlier and reduce the overall cost of your programme, in many cases by millions. He says his organisation has been able to conclude studies considerably earlier than could have been achieved in some other part of the world – in some cases as much as 17 months earlier.
Across Russia there is no shortage of willing participants in clinical trials, partly because of the nature of its healthcare system. It comprises ‘polyclinics’ as the primary care provider supported by regional and national centres of excellence.
"Access to potential study subjects is very good. You can go to one clinic and have access to hundreds of patients as opposed to going to ten smaller private clinics looking for one or two patients from each," says Passov.
But it’s the poor state of the region’s lower standards of living that helps increase recruitment.
"Between Russia and Ukraine you are looking at 200 million people, so it’s a large population. Unfortunately, the population as a whole is less healthy than people in the West," Passov says. "This population looks at clinical trials as an opportunity to get better medical care, diagnoses, access to better and more prominent physicians and treatment they otherwise would have to pay for."
Physicians keen to be involved
"They [physicians] tend to be very interested in being on the cutting edge of medicine and participating in clinical trials along with their Western peers, and there is much less competition for the investigators," says Passov. "In the US, at any given time, there are over 30,000 clinical trials going on; in Russia that number is probably somewhere around 1,500. All of these factors lead to an ability to enrol patients many times faster than in the West."
So in spite of its challenges – a difficult geography, sometimes unclear regulation, and unfamiliar culture and local traditions – the region has a lot to offer those looking for new clinical research avenues if they are willing to investigate the possibilities.
A lot of the work we have to do is educational," Passov concludes. "It’s making sure that people who have an interest in working in the region understand it and make the decision to bring their trial here after they are fully informed. We have had instances where we’ve told our clients that either the population they are looking for or the way their trial is set up logistically would not be appropriate for the region. But in my seven years of working for ClinStar I can only recall three such instances."