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The battle for clinical trials

clinical trials

Which regions are winning the battle for clinical trials? In Sweden, there has been a decline in the number of trials in recent years, while Eastern Europe has become an increasingly attractive region for international pharmaceutical companies to conduct clinical trials.

Developing new pharmaceuticals and testing them on Swedish patients used to be an area where Sweden excelled. But in recent years clinical trials have been diminishing. The number of applications to start clinical trials decreased by an average of 20 percent between 2010-2012 compared to the average between 2005-2009, according to statistics from the Swedish Medical Agency. In 2005, 394 applications were submitted, whereas in 2012 there were only 319. Over the past decade, the number of clinical pharmaceutical trials in Sweden has been halved. This mainly concerns phase I studies, which have almost decreased by 90 percent. More and more tests are instead being performed abroad, to a great extent in low and middle income countries, and many clinical trials are being conducted in the Eastern European region.

AstraZeneca, for example, is one of the companies that in recent years has moved tests from Sweden, and more of the company’s pharmaceuticals are being trialed by people in Asia and Latin America, but also in Eastern Europe in countries such as Poland and Hungary. In an interview for Swedish Television SVT in 2013 Anders Ekblom, former CEO for AstraZeneca AB, said that moving the tests abroad was a parallel to economic development. He did however not agree that the relocations were made mainly for economic reasons. “We make pharmaceuticals for a global market. We have to look at how our pharmaceuticals work among people in other countries besides Sweden. The living standard has increased substantially in countries like China, India, Russia and in Latin America. Then there is a greater competition for where to place the testing activities. And Sweden is a small country in this context,” Ekblom said. He also said that costs are an important factor when it comes to research, and drug development is a costly business. “If you can find different ways to make it less expensive you will of course do it.”

After the fall of the “Iron Curtain” and the disintegration of the Soviet Union during the late 1980s and the early 1990s, the countries of Central and Eastern Europe (CEE) with their total population of about 340 million people (including the European part of Russia), have become increasingly attractive for international pharmaceutical companies as sites to conduct clinical trials. An abundance of well educated, often treatment-naïve patients, who are eager to participate in clinical trials that may offer otherwise unavailable treatment opportunities may contribute to this attractiveness. Further, the availability of numerous highly qualified and motivated clinical investigators without competing trials enhances enrollment success. Poland for example, with a population of 40 million, has become a traditional destination for clinical trials, especially in oncology, hematology, cardiology, hemodialysis and transplantology. Hungary is another attractive destination for clinical trials, with more than 300 clinical trials being performed annually.

“Eastern Europe has been an attractive region for clinical trials as it has maintained the number of clinical trials over the years. The region has long experience, significantly improved quality over the past 20 years, and motivated investigators with extensive experience,” says Lemme Urmet, Clinical Research Manager for the Baltic countries at Medfiles, a private CRO founded in Finland in 1987. “Also, the price level is of course important. The difference in costs differs 20 to 40 percent between for instance Finland and the Baltic countries.”

According to an article published in Drug design, Development and Therapy (2012) many CEE countries still adhere to a public healthcare system organization similar to that of the Soviet Union. With respect to the requirements for clinical trials this includes the availability of comprehensive, often lifelong patient records, comparatively few, but large, specialized medical centers and a tight, mainly “vertical” referral system organized according to therapeutic hierarchies, with only minimal competition for patients between the centers. The availability of patients’ medical histories is also associated with lower screening failure and premature withdrawal rates, as stated in the article. Based on data from 50 international phase II and III clinical trials, for which enrollment data per center and per month were analyzed, it has been estimated that the average site productivity (measured as patients enrolled per site and per month) in Russia, Ukraine, and the Balkans[YUN1]  is more than twice that found in Western Europe and in the USA. When it comes to regulations, the Baltic states, Bulgaria, the Czech Republic, Hungary, Poland, Romania, Slovakia and Slovenia joined the European Union (EU) in 2004, and therefore came under the jurisdiction of EU legislation and guidance for clinical trials.

The economic aspect is an important factor. Costs associated with clinical trials are up to 25% lower in Eastern Europe compared to Western Europe or the USA. However, in the past, cost differentials between CEE and WE were more significant than they are nowadays, both in terms of fees and operational costs. In line with overall economic development, the cost of clinical trials in CEE/SEE/CIS has been converging to WE levels. The cost still remains competitive, however, according to a report by PricewaterhouseCoopers, PwC.

When it comes to the European CRO market, one of the key trends has been seeing Eastern Europe’s emergence as a key hub for handling cost-effective clinical trials, whereas Western Europe faces the subdued state of preclinical-clinical research. Eastern Europe is described as the most promising region for the industry. The leading drivers behind the boom region are for example that it is relatively easy, quick and cost-effective to access big patient populations.

At the same time the Swedish government highlights in a report from 2013 that the trend when it comes to the number of clinical trials is not just negative for Sweden’s part. Several other countries in Europe have also seen a decline in the number of clinical trials, and according to the report it appears that the trend toward more trials in Eastern Europe has been stalled, at least partly due to increasing costs. Looking at the number of applications for commercial clinical pharmaceutical trials, Eastern Europe had a positive increase until around 2011, with a slight decrease in 2012, and now there are around 1700 applications per year.

According to ASCRO, the Association of CROs active in Sweden, the location of clinical trials is a complex matter.

“Our perception is that there are a series of factors that affect where employers chose to place their clinical studies, rather than individual factors that concern individual countries. Studies are for several reasons often cross-boundary, and by looking for collaborations with the right clinics that can demonstrate the right patients, rather than choosing the right country, the probability increases to meet the overall timeframe, or in other words, the time until the results are available. Quite often it is a question of finding specific ‘treatment naïve’ patient groups, which in some cases are a scarce commodity in Sweden and the Nordic countries where Swedish patients generally are well-treated. So depending on the patient group, some countries are simply not appropriate,” says Peter Asplund, the trade organization’s president.

He agrees that the cost is an important factor in how a study is carried out. However, this is a very complex and relative variable that is essentially a product of precision, time and quality. The time it takes to start a study, that is the work of a pilot study, contracting, authority approvals etc. drives time, precision in patient recruitment and quality of collected data. Sweden as a country is very well equipped to compete, primarily when it comes to start up studies and also when it comes to the quality of our data. Nevertheless, we need to get substantially better at mobilizing a larger number of patients per trial, as well as ensuring that healthcare has the resources to deliver these in the appointed time,” says Peter Asplund.

So, how are the Nordic countries to compete with the Eastern European countries in conducting clinical trials?

“Within ASCRO we are working on strengthening Sweden’s position as an appealing country for clinical trials. Considering the increasing number of studies that are being carried out in collaboration with our member companies, it is often an issue about simplifying, standardizing and keeping the cooperation between sponsor, healthcare and us at a good level. In every aspect we agree with the recommendations in the government’s investigation, which ultimately is about a better, more simple and transparent model for placing and conducting studies in Sweden. These are in the end factors that are completely crucial for whether or not Sweden is a competitive alternative,” says Peter Asplund.

 

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