КЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯ В ЦЕНТРАЛЬНОЙ И ВОСТОЧНОЙ ЕВРОПЕ

Погребниченко Т. И.

Аспирантка, Высшая школа экономики (Прага)

КЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯ В ЦЕНТРАЛЬНОЙ И ВОСТОЧНОЙ ЕВРОПЕ

Аннотация

В статье приводится результат изучения и оценки  10 стран Центральной и Восточной Европы с точки зрения перспективности проведения в них клинических исследований.

Ключевые слова: клиническиe исследования, мультикритериальное принятие решений

Pogrebnicenco T. I.

Graduate, University of Economics (Prague)

CLINICAL TRIALS IN CENTRAL AND EASTERN EUROPE

Abstract

The article presents results of study and assessment of 10 countries in Central and Eastern Europe in terms of prospects of conducting clinical studies.

Keywords: clinical trials, multi-criteria decision making

Discovering and bringing one new drug to the public typically costs a pharmaceutical or biotechnology company from $800 million to more than $1 billion and takes an average of 10 to 15 years. But despite this healthy margins and little appetite for risk have kept most pharmaceutical companies close to home, for all but their manufacturing activities. Recently the financial pressures increased, and the pharmaceutical executives found that going offshore brings less risk than before but also they found that it actually is too attractive to ignore. Finding new locations is of particular interest for carrying out clinical trials as they are representing two-thirds of the budget for developing a new drug. Before, the leading global pharmaceutical companies conducted the majority of their clinical trials in familiar territory, with most trials taking place in the United States and Western Europe, but from 2002 through 2007 the number of global clinical trials initiated in Central and Eastern Europe more than tripled. Even thought the population in the entire CEE region is less than half the population of India or China, the number of clinical trials initiated last year here was more than twice as big as in the total Asia-Pacific region [1]. Various factors are decisive for choosing a country to conduct a clinical trial. This choice is made depending on the location of key partners, internal facilities and future product launches. For example, depending on the choice of location, cost savings can range from 30 to 65 percent compared with sites in the United States or Western Europe. The revenue implications are equally attractive.  In low-cost countries, clinical trial phase III can be finished up to six or seven months faster than in domestic markets. If looking at this from a practical point of view this is getting the drug to the market in a shorter period - therefore becoming earlier of good use for patients, faster returning the investment, a potential advantage over competitors and a longer patent protection. In devising their offshore strategies, many pharmaceutical companies do not use the same scientific rigor that defines their industry, and instead make decisions based on existing relationships and anecdotal evidence. This is partly because executives do not have the hard data necessary to make such decisions.

With this in mind the goal of this study is to provides a fact-based ranking of low-cost countries, to highlight the evolving clinical trials landscape and, perhaps most important, to provide pharmaceutical executives with a stronger foundation from which to make more informed clinical offshore decisions. In order to achieve this goal, the attractiveness of 10 offshore locations of Central and Eastern Europe are calculated in this study by evaluating six key areas: patient availability, cost attractiveness, relevant experience and quality, regulatory conditions, infrastructure and environment. Locations were investigated and detail described by reviewing 4 main areas: general country overview, health and development, clinical trials overview and regulatory. For the purposes of this study the multi criteria decision making method named weighted sum approach was chosen. The results of this study are expected to make the evaluation of the country attractiveness for clinical trials possible and to provide a fact-based country ranking.

The process of drug development in the form it is known today is the result of co-evolution of more disciplines, with biology and chemistry being the key ones but not only the important ones. Science, business and law are the fields that modeled the modern research in the way it is now. The one thing that remained the same is the goal which is finding new medicines to cure diseases and alleviate suffering. The rest as the diseases, the perception of their mechanisms, the technologies available for use, the corporate structures of organizations doing such research, the economic, legal and regulatory context have changed [2].

The process of developing a new drug is very time-demanding and expensive, also all the expenses have to be covered before the drug would bring any benefit. The cost was estimated to be about $1.3 billion for a new chemical entity that is why this research field needs a stable financial support. The duration of the process can be from 10 years in case of acute diseases and up to 14 years for chronic diseases [3].

Central and Eastern Europe, including the European part of Russia, represents a considerable part of the European continent with a population of about 340 million people. In the beginning of the 90s the compliant research for good clinical practice began in this region and it shows high-quality results and a stable patient recruitment. The medical community and the patients from the CEE countries have always appreciated the locally accomplished clinical trials because they have widened the variety of options in the specialty field by giving access to innovative therapies to both patients and doctors. CEE countries became an appropriate territory for clinical research, which made it possible for the number of clinical trials in the region to grow. The favorable and homogeneous regulatory framework permits a relatively simple approval process of multinational trials without delays. Patient recruitment is a 3 to 4 times faster process than in the Western sites; it is thanks to the accessible pools of subjects and very motivated investigators. When comparing to the West, the costs of carrying out a clinical trial in the CEE region are competitive primarily thanks to shorter timelines, and in addition the quality achieved is the same or even better.

For the determination of criteria for selection of countries that could be potentially attractive for clinical studies, was used discussion based method, which is based on measuring of the important functions of the analyzed object or process using elementary methods of scientific investigation, such as analysis, abstraction, deduction and induction [4]. For the analysis criteria were weighted according to the relative importance each plays in making location decisions. To establish the weight of criterion, expert evaluation of the function’s importance was used. This method is based on the experts’ professional opinion about the importance of ranking criteria [4]. Relative weights could adjust the results of a country's attractiveness, however, sensitivity analysis highlighted that the positions of the top three countries remained unchanged. Data was derived from both primary and secondary research. Primary research included interviews with pharmaceutical professionals. Secondary research included data from the United Nations, the World Bank, the World Health Organization, the U.S. Food and Drug Administration, and the U.S. National Institute of Health. The result of the methods developed into the selection of the criteria listed below:

• Patient availability
• Cost attractiveness
• Relevant experience and quality
• Regulatory conditions
• Infrastructure and environment

For the purposes of this study calculations the multi criteria decision making method named weighted sum approach was chosen. The Weighted Sum Approach technique is based on linear utility function. The alternatives are considered the weighted sum of normalized criterion values. This method is computing their global utility and offers a full ranking of alternatives based on them [5].

Graphical representation of final country ranking is given below in Graph 1:

Graph 1 - Final Country Ranking

It is not a surprise that Russian Federation is situated on the first place in the list of the most attractive countries for clinical trials conducting. In addition to smaller expenses Russia has a very attractive patients’ pool to offer. It has a centralized health system that is keeping all the patients with the same disease in one department; this is making the enrolling process much easier and faster. Also most of the patients are treatment naïve, which means that they were never before involved in a clinical evaluation. All these factors make the enrollment process to be sometimes even 10 times faster than in West Europe, which is an important time and money savior.  Nevertheless, except all the above mentioned benefits, Russian market means a lot of problems too. Some of the significant limitations are the poor intellectual property standards and different forms of governmental involvement, for example taxes for the clinical research. The organizations that decide to carry out researches in Russia must prepare a detailed plan and take care of the process of patient enrollment in order to ensure the application of international ethical norms.

The goal of this thesis was to provide a fact-based ranking of low-cost countries, highlights the evolving clinical trials landscape and to provide pharmaceutical executives with a stronger foundation from which to make more informed clinical offshore decisions. The obtained results can be used as recommendations in order to ease an informed offshore decision of the pharmaceutical companies and lower the risks that are related to coming to a new country.