clinical-trials-in-poland-2010

clinical-trials-in-poland-2010 - Clinical Trials in Poland...

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Unformatted text preview: Clinical Trials in Poland – Key Challenges November 2010 Table of Contents 1. Summary 1 2. Introduction: A global view 7 3. Clinical trials in Poland: Key characteristics 25 4. Benefits and risks of clinical trials 42 5. Barriers to market development 55 6. Conclusions 71 Appendix 1. Glossary 83 2. PwC Contact 86 Section 1 Summary Summary: Key messages • Clinical trials are necessary to ensure efficacy and safety of newly developed medicine. • Sponsors seek for increased operational (and cost) efficiency primary by outsourcing trials to CROs and considering new locations for research projects, e.g. CEE-based, due to constant developments in pharmaceutical industry, such as declining productivity of R&D spent caused among others by upcoming patent expiry of blockbusters as well as expected shortening of drug development. • Poland remains the largest clinical trials market in CEE/CIS, however, both patient participation and site penetration rates indicate a potential for growth. • The clinical trials market in Poland is worth c. PLN 860 m. • Clinical trials in Poland imply a number of tangible and intangible contributions to Polish society and economy: – Provide access to advanced therapies for patients, combined with better standard of medical care; – Contribute to human capital growth in terms of know-how sharing and professional development opportunities for medical staff; – Contribute to the Polish economy with c. PLN 860 m of which vast majority is a cash inflow and the state budget with c. PLN 240 m of taxes paid by sponsors/CROs, CEBK fees and Ethical Committee fees as well as provide alternative cost savings that can relieve the public healthcare system. • Launching a number of initiatives will accelerate the market growth and maximize the potential benefits to the economy: – Improvement of timing/feasibility of administration procedures, which is expected to increase the trials volume by c. 20%-30%; – Improvement of the level of transparency, especially in terms of clear competency split between different regulatory and approval bodies (e.g. CEBK and Ethical Committees) as well as the relationship between the sponsor, the researcher and the site; – Establishing administrative processes improving cooperation between sponsors and sites. 2 Clinical Trials in Poland – Key Challenges Section 1 Summary • Clinical trials are necessary to ensure efficacy and safety of newly developed medicine. Since they are key in the drug development process, they appear to be an increasingly hot topic; – Global clinical research market is worth c. USD 50-80 bn (depending on the source of information). In 2009, over 17k clinical trials were newly registered worldwide....
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This note was uploaded on 07/08/2011 for the course BM 501 taught by Professor Kop during the Spring '11 term at Bloomsburg.

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clinical-trials-in-poland-2010 - Clinical Trials in Poland...

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