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European Pharmaceutical Contractor
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There has been steady and significant change in clinical research over the last decade; investigation sites in Central and Eastern Europe (CEE) have become increasingly competitive, and at times have even out-performed their European and North American counterparts. This article aims to provide some discussion points on the rationale behind this changing scenario and give an overview of conducting clinical trials in CEE countries.
Around 236.3 million people live in Poland, the Ukraine and the European part of Russia. In these three countries, the number of doctors per 1,000 inhabitants is between 2.3 and 4.6; the number of University medical faculties stands at 12, 18 and 55 respectively; and the number of hospital beds per 1,000 inhabitants is between 6.2 and 10.8. According to WHO data, health spending is respectively 6.3, 2.2 and 3.5 per cent of GDP (the mean European is six per cent) and the mean hospital stays are 10.1, 15.7 and 16.3 days respectively (see Table 1). Internet access is estimated at 40 per cent for general medical practitioners in Poland and 4.5 per cent in the Ukraine. In the last few years, the clinical research climate in Poland, the Ukraine and Russia has changed significantly, with an estimated increase of 10 per cent per year in multicentre clinical trials, thus Central and Eastern Europe are playing an increasingly important role in the development of new drugs (see Figure 1, page 46).
The steady increase in clinical research carried out in these countries correlates directly with the continuous improvements in their efficiency and quality standards. To participate in clinical research projects means you need to grasp opportunities: gaining experience with new drugs not yet on the market; improving methods and technologies; offering groups of patients new treatments and health assistance free of charge; increasing the centre's status in the scientific community; obtaining benefits from funding; and interacting with scientific investigators from other countries.
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By Giancarlo Carmosino, Clinical Trials and Health Care Technology Development Director of CROM srl and Wanda Malkowska, General Manager of CROM Polska
Giancarlo Carmosino is Clinical Trials and Health Care Technology Development Director of CROM srl. Before joining CROM in April 2004, he spent 19 years in multinational pharmaceutical companies where he was responsible for clinical research, health care research, medical departments and pharmacovigilance. He has co-ordinated national and international clinical trials for drug development in a variety of therapeutic fields. From 1999 to 2003, he delivered more than 30 courses on clinical research methodology, evidence-based health care, clinical guidelines and disease management.
Wanda Malkowska is General Manager of CROM Polska. Her background includes 20 years' experience in scientific research and extensive experience in preclinical and clinical development of different drugs, as well as studies concerning the influence of drugs on healthy people and immunological system. She has conducted and co-ordinated international clinical trials with a responsibility for the monitoring and CTA co-operation as well as identification of investigation sites through feasibility analysis, authorisation processes and management of project time schedules.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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News and Press Releases |
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MipTec, October 14 – 16, 2008, Switzerland
MipTec about to take off by joining forces between Life Sciences Week, ALL-SystemsX.ch-Day, & Jobvector.com
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