Emerging Markets Clinical Trials: Eastern Europe (PH145)

&nsbp;

CLICK TO DOWNLOAD
Published 2010
187 Pages
400+ Metrics
12+ Charts and Diagrams

Overview Metrics Excerpts

Expand Clinical Capabilities Throughout Central and Eastern Europe
The countries in Central and Eastern Europe provide ample opportunity for life sciences companies, especially in terms of clinical development. The number of treatment-naive patients in the region makes it an ideal location to host clinical studies. In fact, the population of Central and Eastern European countries exceeds that of either the United States or the five largest Western European markets combined. Furthermore, there is a lower saturation of competing trials within the region compared to other, more developed markets.
Besides a large patient population, Central and Eastern Europe offer the drug and device industries a convenient location — especially for European-based countries — to conduct clinical studies. The region has a long history of clinical development, making it easier to find and train skilled investigators.
Use this study as a resource to design and prepare your company's clinical trials in Central and Eastern Europe. The report addresses, in detail, the cultural
challenges in clinical trials and clinical development opportunities that these emerging markets provide. It provides detailed benchmark metrics for Russia, Poland, the Balkans, Bulgaria, Romania, Turkey and Ukraine, all in one place. Learn the advantages and challenges that each of these countries present. Use these data and best practices to avoid common pitfalls and solidify your clinical strategy:
Improve Patient Access
Russia and Poland offer a distinct advantage as emerging markets: access to treatment-naive patients. Recruitment and retention are strong in these countries as well. This report will guide your decision-making process as you determine how to run a trial in a Central or Eastern European nation.
Protect Intellectual Property
IP issues can be daunting when working in an emerging market. This study shows you how to work with local partners to navigate culture and regulations, avoid the threat of corruption and protect your intellectual property.
Tap Geographic and Cultural Proximity
Russia, Poland and the other countries profiled in this report offer the advantage of being neighbors to Western Europe. This means that the local investigator knowledge base is similar to that of Western European countries, and EU-EC guidelines for GCP are becoming more commonplace. Learn about the other advantages that the central and eastern European countries offer to clinical development teams.
Back to Top
Back to Top
Clinical Trials in Europe Metrics
The Cost of Running Clinical Trials in Europe: Executive Summary
- Average percentage of budget saved by running a site in Central and Eastern Europe
- Average percentage of time saved by running a site in Central and Eastern Europe
- Population comparisons between Central and Eastern European nations, the United States and Europe
- Number of registered studies across profiled Central and Eastern European countries
- Rankings from surveyed companies of benefits and challenges:
The three chapters in Emerging Markets Clinical Development Series: Central and Eastern Europe use primary and secondary information to provide comprehensive overviews of the clinical development environment in Europe's emerging markets:
Section 1: Clinical Development Overview
- Key demographics (population/ethnic breakdowns, life expectancy statistics)
- Key economic figures (GDP, labor force, distribution of family income)
- Disease prevalence
- Politics
- Healthcare system
- Pharmaceutical market (overall picture of market, leading local companies)
Section 2: Clinical Development Environment
- Percentage of budget saved by running a trial in this location
- Percentage of time saved by running a trial in this location
- Assigning clinical development responsibilities
Clinical Trial Environment Scores and Trial Operations Scores
Environment
- Available knowledge base
- Regulatory environment
- Intellectual property laws and practices
- Communication/language
- Culture
- Anticipated cost
Operations
- Access to patients
- Patient retention rates
- Investigator standards
- Data standards
- Site management standards
- Trial technology infrastructure
- Supply chain management
Section 3: Individual Company Profiles
This report contains a total of 18 company profiles that contain the following components:
Company Background
- Company mindset and key clinical feasibility factors
- Factors that impact clinical environment
Clinical Environment Assessment:
- Regulatory environment
- Available knowledge base
- Intellectual property laws/practice
- Communication/language
- Cultural concerns
- Anticipated cost
Trial Operations Assessment:
- Access to patients
- Patient retention rate
- Investigator standards
- Site management standards
- Data standards
- Trial technology infrastructure
- Supply chain management
Experience in Region
Activity in Region: Maps the geographic scope of the company's clinical operations within the region.
Experience Specific to Country: provides information on the company's operations within the country, including year of entry, method of entry and current level of presence within the country.
Clinical Strategy in Country
Responsibility breakdown shows each company's clinical operations assignments among four groups - corporate team outside country, corporate team inside country, multinational CRO, and local CRO/vendor. The data detail 12 clinical responsibilities:
- Protocol development
- Site selection
- Investigator training
- Patient recruitment
- Site monitoring
- Investigator management
- Data collection
- Data management
- Data cleaning/analysis
- Medical writing
- Regulatory agency communication
- Health economics consideration
Clinical Environment and Trial Operations Scores
Shows a company's score for each of the clinical environment and trial operations factors listed above.
Back to Top
Clinical Trials in Europe Report Sample
The following excerpt is a small portion from Chapter 2, "Poland." The first half of the chapter explores in-depth Poland's clinical development environment, including demographics, economics, politics and healthcare system.
Healthcare System
Public health has been a mainstay in Poland since 1952. During the Communist era, free healthcare for all citizens was written into the constitution, and basic needs have been provided ever since. For Poles who rely on government healthcare or reimbursement from the National Health Fund (Narodowy Fundusz Zdrowia, or NFZ), receiving treatment can be difficult. Waiting rooms in the large, regional centers are overflowing, and waiting lists for medical device procedures can be years long. These inefficiencies drive patient participation in clinical trials.
At the ground level of Poland's healthcare system are primary care doctors and clinics. For diseases outside the expertise of a primary care physician (PCP), patients are referred to a hospital (regional or academic) or to specialized institutions, such as an oncology institute or children's hospital.
Wealthier residents choose to obtain private health insurance for added level of care, greater access to physicians and new treatments. But the gap between those who can afford private health insurance and those who cannot is great. Publicly run health centers and the NFZ may not offer reimbursement for specific specialized treatments.
Although certain lines of treatment for cancer and for other rare diseases have become the standard of care in other parts of the world, such treatments are not offered by the NFZ. In this respect, Poland's healthcare system is still emerging. As such, Poland has an abundance of treatment-naive patients, eager to participate in clinical trials.

The following is an excerpt from Chapter 2, section 2, "Clinical Development Strategy." The section includes executives' best practices based on their experiences conducting trials in Poland.
Available Knowledge Base
Poland has a wealth of capable doctors and investigators. Medical personnel are hungry for knowledge and eager to participate in clinical trials - both reasons why the available knowledge base received a high score of 7.7 from survey respondents. Many of the principal investigators at the top research centers attend international conferences and are up to date on the latest treatments, making them comparable to investigators in Western Europe. Nevertheless, in Poland the newest treatments are not always made available to patients. Physicians often jump at the chance to participate in clinical studies that can offer their patients access to cutting-edge treatments.
A majority of the clinical research associates in Poland were originally doctors. They are extremely knowledgeable and communicate very well with principal investigators and study coordinators alike.
One executive from a global CRO notice a healthy camaraderie and competition between principal investigators, who are often willing to communicate best practices across different sites. Many investigators, especially within the same therapeutic areas, have been working side by side on clinical trials for 10 years or longer.
The competitive side of investigators is manifested in the quality of work. Each investigator knows that quality clinical work and attention to detail will help them earn more business. In addition, there is a general sense of pride within the Polish healthcare system. Physicians understand there is a stigma attached to operating in an emerging health environment. They work hard to show the outside world that Poland is fully capable of running global clinical trials.
The rapid expansion of private clinics interested in clinical trials means that the pool of talented research coordinators is also growing. According to one CRO executive, an experienced research coordinator is the most important piece of the puzzle. The CRO takes great care to ensure that each site selected has up-to-date medical technology and a research coordinator with years of experience.
Back to Top