Clinical trials Eldorado based on quality, not cost

Central and Eastern Europe is proving very attractive to pharma and biotech companies for clinical trials.  Highly motivated patients, well-qualified investigators, speed of trials and quality of data as well as lower costs are frequently listed attractions.  All together, the population of Central and Eastern Europe represents greater number of people than that of either the United States or the five largest Western European markets combined.  Besides, the region also offers a convenient location—at the heart of Europe—for drug and device industries to carry out clinical trials.  This article explores in many details the reasons that make the life science industry come back over and over again to these territories. As they have gained their reputation through a combination of rigour, high education levels and historic legacy.

Unique healthcare setup

 Experts believe what makes the country attractive are manifold. One key aspect is the ability to access suitable pool of patients. “It is about patient availability.  There are patients willing to participate and they are adequately treated so the data collected will be valid,” explains Wojciech Przybys in Poland. He is head of clinical site monitoring for Central and Eastern Europe with Quintiles, an international clinical research organisation (CRO). There is also a high engagement by patients, he adds:  “They trust doctors and so protocol compliance is very high.”

Then, there is a socio-cultural legacy in that historically Eastern Europe had a very centralised healthcare. They also have sophisticated treatment centres for specific conditions staffed with the key specialists. “That gives ease of access to specific patients,” adds Przybys. Quintiles set up a Polish office in 1999 in Warsaw. The office now employees 250 people, the vast majority with advanced degrees.

Top investigators

 Another oft-repeated advantage by CROs in the region: investigators are well qualified and motivated.  Requirements for specialists involved in clinical studies have always been higher here, says Anna Yanaeva of OCT, a CRO headquartered in St Petersburg , Russia, but with offices in Bulgaria, the Baltic states and Belarus. “OCT is not an exception – 90% of our [clinical research associates] are medical doctors, the rest are pharmacists.”

Others concur on the quality of clinicians.  “Doctors spend a lot of time working on the trials and the data is very good,” says Juraj Petrinec, who set up CRO Clinitria in Bratislava, Slovakia, which has operated in 10 other countries in the region. The extra money, he says, offers an incentive for the doctors and hospitals, which can use it to fund other activities.  He too argues that lower cost is no longer the major pull for clinical trials; he points to the excellent audit results and stringent assessments by the likes of the US drug regulatory agency, the Food and Drug Administration, in the region.

Quality above cost

Countries like the Czech Republic, Hungary, Poland and Ukraine created a solid base for clinical research and a pool of qualified providers, according to Anna Baran, chief medical officer with KCR, a CRO set up in the region back in 1997. Historically, industry looked to the region to save money, she notes. But with increased competition in the market and rising labour costs, the region increasingly stands out for the quality it offers rather than for cut rates.  She points out that clinical data is processed mostly by physicians themselves.

“One of the reasons Western sponsors often think of when placing a trial in Eastern Europe is the low costs. This is a cliché,” advises Yanaeva. Average budgets are now the same as in Western Europe, though “short start-up periods can help shorten study timelines and, consequently, cut costs.”

Nonetheless, some experts indicated that average costs are perhaps 15-20% lower. There is no consensus on the matter. Costs in Poland are estimated at 30% less than the cost in the US by Krzysztofa Łuczak-Szymerska, associate director of project management at Cromsource, a CRO that with an office in Warsaw, Poland.  The costs are relatively low “due to a high rate of patient recruitment and excellent quality of data, leading to a reduced number of rejected clinical trial recordings and time-efficient proceedings.”

Others believe that Eastern Europe is cheaper because in many parts of North American and Western Europe hospitals levy high indirect costs on pharmaceutical companies for using their facilities.  “Eastern Europe is keen to get more involved in studies and willing to do them for less,” says John Warner, professor in paediatrics at Imperial College, London, UK. He believes international agreements and oversights means there is much less chance for any work to be substandard.

Access to care

While patients in Western European countries can have access to good medical care in public hospitals or thanks to their medical insurance, Łuczak-Szymerska says this is not necessarily the case in Poland: “Access to the national health system is limited and medications are expensive. Hence, with the offer of better medical care, free drugs and diagnostics procedures, patient recruitment in clinical trials is very high. This factor is particularly important when treating patients in areas where the availability of effective drugs is limited” – such as in oncology or transplant treatment.

As a result, some also say there are good numbers of treatment-naïve patients, with oncology named as an example. It is a popular area of clinical research in Poland because “it is relatively easy to find here patients in the late stages of the disease,” says Łuczak-Szymerska, which is not true in Western Europe. “Approximately one-third of patients in clinical trials in Poland are oncological cases. This results from the relatively long time patients may have to wait to see a specialist in Poland, meaning participation in clinical trial shortens the waiting time associated with receiving specialist care.”

In fact, Poland stands out as important partly due to sheer size.  With a population of around 38 million, it conducts around 20% of all trials and the market is worth around €200 million.  It also boasts specialised medical centres in about 9 main cities, which provide access to patients in areas such as oncology, rheumatology, cardiology and paediatrics.

Towards a level playing field

Beside oncology, other CRO representatives believe that, for specialties like cardiology or diabetes, Central and Eastern Europe offers the same infrastructure and trained staff as Western Europe. This is especially true in the larger cities and hospitals, where, often, new equipment is being installed.  Besides, Clinitria’s Petrinec says that EU legislation has evened out the landscape as regards to standards. He believes that there is not that much difference between Eastern and Western Europe now.

Others concur that any gap that existed say 20 or 30 years ago between professionals in Eastern and Western Europe has closed significantly. “Certainly in countries like Poland, Czech Republic and the Baltic states, the doctors there have been members of European specialist organisations for many years and there has been quite a sizeable exchange of staff across Europe with those countries,” says Warner.

Still, there are discrepancies between nations. “There is a pool of countries with competitive start-up timelines, such as the Baltic States, which are always critical for start-up companies and biotechs,” comments Baran,“From an enrolment perspective Poland and Ukraine remain very attractive [due to their large populations].”

While big countries have the advantage of large populations, “small countries have the advantage of flexibility and motivation on the side of their investigators,” says Clinitria’s Petrinec. He lists neighbouring Czech Republic as an example of a country where he likes to work. “The regulatory bodies are demanding, but in a good way, and the investigators are really good,” he explains.

Remaining challenges

However, there are a few remaining challenges.

Łuczak-Szymerska says that a key challenge for the Polish clinical trial market is shortening the time and standardising of administration procedures regarding the signing of clinical trial agreements with the sites, which may vary. Also, Przybys says managers in hospitals in Central and Eastern Europe tend to change more often than other parts of the world, which may lead to a shift in approach at the same hospital.  And Petrinec says Clinitria has inherited some work due to the poor performance of newer CROs.

Yet, CROs in the region argue that it’s the quality on offer that will continue to prove attractive to global firms. Przybys concludes:  “Central Europe has 20% to 30% less audit findings than the global average and this has been a consistent performance over the last 15 years.”  This shows that clinical expertise found in Central and Eastern Europe is made available to life science companies in a two way process of mutual benefit. “The world is getting smaller, and, as far as medicine is concerned, there has been a valuing of people’s experience and expertise in different environments,” concludes Warner, “It has brought people together.”

Anthony King

Anthony is a freelance science journalist based in Dublin, Ireland.

Additional reporting Marcin Krasnodębski.

Go back to the Looking East Special Issue

Photo credit: Sanofi Pasteur

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