CEE Clincal Trial Market Advantages
An essential element in assessing the efficacy and safety of a new drug is clinical research. It is estimated that the global clinical research market is worth 50-80 billion US $, with a rising tendency. Growing industry forces pharmaceutical companies and sponsors to expand to new regions. The area of particular interest is Central and Eastern Europe (CEE) with the number of clinical trials registered in this region reaching 2000 per year – which confirms this trend.
CEE is one of the most dynamic and fast growing markets owing to:
1. Patient population.
Recruitment of patients in Central and Eastern Europe is much higher than that in Western Europe and the USA. This is due to the fact that the majority of state health care clinics are placed in large, specialized, and easily accessible sites with a large population of patients. In addition, patients in the region have less access to modern therapies – not reimbursed by government programs, which means that patients often meet the inclusion criteria and they willingly agree to participate in studies. This is also an important element that has an impact on investigators’ motivation. These data were confirmed by Clinmark on the basis of approximately 65 audits conducted in the region. In addition, based on our experience, it is clear that this region is often treated by the Sponsors as the one that “saves the day” in terms of recruitment. Many a time have we been able to organize a clinical trial in such a way as to help meet the global recruitment targets due to the knowledge of region specificities, opinion leaders and the possibilities of sites (e.g. in a global study of metabolic disease we were able to achieve a recruitment level of 205%, at the request of the Sponsor)
2. Motivation, commitment and experience of investigators.
For investigators working in the regionit is ennobling to cooperate with the top pharmaceutical representatives as well as participate in the development of innovative therapies and treatment of patients with the use of the most effective and modern drugs. Due to relatively low salaries in public health sector, participation in clinical trials may be an additional source of income for the investigators. A direct contact between investigators and patients constitutes an important aspect in patient retention due to the individual approach of investigators towards patients, which is contrary to the trend in Western Europe with virtual contact between a patient and an investigator being more and more common. Clinical research has been present on the Polish market since 90s, therefore both investigators and ethics committees have had a lot of experience and high awareness of the principles of good clinical practice and clinical trials conduct. Considering Clinmark’s 13 years of comprehensive experience on the market, our professionals have been able to get in touch with the best investigators (selected on the basis of long-term cooperation), including specialists and professors who have access to a large population of patients; covering 90% of major therapeutic areas. In 45% of our research activities, we cooperate with professors which ensures the highest quality of research.
3. Competitiveness of cost-effectiveness.
The costs related to site payment, Investigators’ salaries and monitoring in CEE areestimated to be around 25-30% lower compared to the costs of the above mentioned in the US or Western Europe. Based on the market research, Clinmark predict that the level of spending related to clinical research in the region is not going to change significantly over the next few years. Despite the mature market in Central Europe, we can still observe a dynamic growth of Eastern European market.
4. The efficiency of clinical research.
Most CEE countries are EU members subject to uniform regulations that are in line with EU directives. In most countries approval timeline of health authorities is 60 days. Once the approval and implementation of new Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use have been concluded, further improvements to the process are expected to be introduced in 2016. Clinmark place special emphasis on the optimal set up of clinical trial, including the strategy that ensures maximum effectiveness of a clinical trial registration.
5. Education and skills of monitors.
Indubitably, CEE specialists in the pharmaceutical industry are among the best educated and skilled professionals. The high level of academic education and a high number of monitors and project managers, who are medical universities graduateswith high level of competence, contribute to high level of professionalism. A good example is Clinmark’s management team. All team members are the Medical University of Warsaw graduates. To ensure the highest quality of data and better understanding of the research process, we only employ highly qualified people; graduates of pharmacy and associated fields. In order to continuously improve personnel qualifications we have introduced a demanding development program based on mentoring and coaching as well as periodic assessment of their competence, which helps us better adapt to the needs of our clients.
FDA inspections show that the quality of clinical trials in CEE is at the highest level and can be compared to the quality of research conducted in Western Europe and the USA which is displayed in the following diagrams:
These data are consistent with the results of audits carried out by Clinmark in more than 30 countries around the world including the participation of our employees in FDA inspections as independent translators.
Clinical Trials Market in Poland
Poland occupies the tenth place in the world and it is at the forefront of the emerging markets in terms of the number of clinical studies; 20% of all clinical trials in the regionare conducted in our country. We are also one of the most important global markets – more than half of the pharmaceutical companies operating in our market have conducted research of 80% of all drugs introduced to the global market in Poland. The size of the population reaching nearly 39 million, effective recruitment and high quality constitute the driving force for clinical research. In terms of figures, 422 studies were registered in 2013 with more than 30 thousand participants. The most common therapeutic areas include oncology (20%), rheumatology (10%), cardiology, diabetology and paediatrics. Multicentre phase III trials are commonly conducted studies with Poland frequently achieving the highest recruitment goals while maintaining the high quality of data. Clinmark has a significant database of research sites specializing in clinical trials in the areas of oncology, rheumatology, haematology, gastroenterology, neurology and nephrology which ensures effective recruitment.
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