The global pharmaceutical market is expected to grow dramatically by the year 2020 (doubling to $1.3 trillion); with approximately 19 percent coming from Brazil, China, India, Indonesia, Mexico, Russia, and Turkey (PricewaterhouseCoopers, “Pharma 2020”). Participating in clinical trials since 1989, Russia, with its 142.2 million population and 300+ ongoing international multicenter clinical trials, ranks number one among these countries. According to Synergy Research Group, Russia is one of the world leaders in patient enrolment - the average patient recruitment rate in 2006 exceeded 4.7 patients per site per month.

Clinical trials are the basis for determining the safety and efficiency of pharmaceuticals, biologics, and medical devices. They are a field of science which is subject to strict regulations specified in the legal acts pertaining to the industry so as to protect the subjects by means of appropriate procedures for organizing, monitoring, and controlling each trial.

According to research firm Euromed Communications, Central and Eastern Europe (CEE), which includes Russia, plays a vital role in global clinical R&D. With 350 million people, CEE has become the second source of Caucasian patients in the world for commercial clinical trials, after the U.S.

Why Clinical Trials Are Moving East
Pharmaceutical companies are increasingly shifting clinical trials to emerging markets - as much as 40% of all drug trials in 2005, up from about 10% in 1999 (FORTUNE Magazine). Trials continue to shift to poorer countries in search of more patients, lower costs, and faster recruitment. Further, many of these countries have centralized health systems; meaning that hundreds of patients with similar symptoms are found in the same place. And, the subjects often have not built up resistance to new drugs from years of antibiotic treatment.

The shift from the U.S. and the UK to countries such as Russia is largely being driven by economics - faster time-to-market equals lower costs. According to Parexel Pharmaceutical R&D Statistical Sourcebook, the average cost per patient in Eastern Europe is 28 per cent lower than in Western Europe. Running a Phase III trial with 300 patients enrolled in Russia could save companies up to $4,134,000 in direct costs, plus faster patient enrolment could generate savings of a few million per day in early product launch (Parexel analytics, 2007/2008 and Cutting Edge Information).

The Russian clinical trial market is attractive to drug companies for many reasons, including:

• Large patient population


• Highly motivated patients (free access to modern treatment, cultural reliability on doctor’s opinion)


• Centralized healthcare system


• Poor health insurance


• Qualified Investigators eager to participate in clinical trials: professional prestige, material incentives


• Benign regulatory atmosphere and public opinion


• Regulations based on ICH Good Clinical Practice (GCP)


• Reliable data used in support of many successful NDA approvals

The Downside
The opportunities for the life sciences industry in this part of the world are growing dramatically, but the market is also becoming more dynamic, diverse, and complex. Bureaucracy – mixed with local regulations, logistics, and customs processes different from those in the U.S. – can be problematic, as well as time and resource consuming for both foreign sponsors and CROs. And, Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards, although officially adopted and respected, have to be controlled very carefully by locally based monitors and auditors.

In addition to differences in local regulations and accepted practices, conducting trials in another country requires Project Management of an operational team in different time zones, translation of essential documents, and certain cultural and language differences. For example, labeling of packages in some countries is considered advertising.

Getting Started
It goes without saying that you’ll need to visit Russia in order to choose a local partner and team – and then rely on the expertise of your local team for input on regulations and laws. Further, obtain advice from available U.S. consulting companies that specialize in Russia/ Eastern Europe clinical study management.

To find out more about the clinical research industry, access this issue’s useful links and industry events.

SOURCES:
PricewaterhouseCoopers, “Pharma 2020”
Euromed Communications
Bhatt, Arun, "(Clinical) Trials and (Regulatory) Tribulations," published in the Express Pharma Pulse (2003).
"UK Regulations - Tougher on Drugs," published by The Economist Intelligence Unit (2007).
Parexel Pharmaceutical R&D Statistical Sourcebook, 2007/2008
Cutting Edge Information
Synergy Research Group