spacer
home > epc > autumn 2011 > local wisdom
PUBLICATIONS
European Pharmaceutical Contractor

Local Wisdom

Poland is rapidly becoming one of the foremost clinical trials markets for growth in eastern Europe. Building a robust strategic alliance with a local team will put early phase studies on the right track.

There are many advantages to conducting clinical trials in Poland.Apart from access to a large population of treatment-naïve patients, as well as patients linked to highly specialised hospitals, Poland is in a convenient European location and offers a good selection of investigator sites with well educated clinical staff willing to conduct clinical trials.

Unique alliances play a pivotal role in supporting the drug development industry. This article explores the increasing interest in Poland as an emerging market to conduct clinical trials, due to successful patient participation and recruitment. It also highlights how establishing a unique alliance can add extra value to early phase programmes by offering access to volunteer populations that would otherwise be difficult to recruit.

Advantages of Conducting Clinical Trials in Poland

Currently, there is an increase in the number of requests from sponsors for accelerated recruitment times in clinical trials with optimal cost-efficiency and without any reduction in quality.To meet these expectations, CROs and pharmaceutical companies are conducting a growing number of trials in eastern Europe.

Opportunities
Covering a total area of 312,680 km2 and with a population of 38 million (with over half of these concentrated in urban areas), Poland is the sixth most populated member of the EU. Key diseases belong to the cardiovascular, respiratory, digestive, nervous and muscular systems. Poland also has one of the highest prevalence of tobacco use compared to other European countries, as overall 27 per cent (8.7 million) of its population are smokers.

Patient Access
Poland offers a strong potential for increased access to patients. Having a centralised health system means that patients suffering from certain conditions – including renal/hepatic impairment, diabetes, asthma and COPD – are treated in specific hospitals or clinics, and can be identified much quicker than in a system that is decentralised.

For Poles who rely on government healthcare, receiving treatment can sometimes be difficult and medication expensive. Although certain lines of treatment for rare diseases and cancer have become the standard of care in other parts of the world, these treatments are not offered by the National Health Fund in Poland. These challenges in the national health system have made the importance of medical research and access to appropriate drugs even more relevant to the patient population. As a result, patients are keen to participate in clinical trials and retention rates are strong. Generally, patient recruitment in Poland is regarded as efficient and when comparing various trials that have been run simultaneously in western and eastern Europe, Poland has regularly been listed at the top of recruitment scales (1).

Well-Educated Knowledge Base
Poland boasts a wealth of capable doctors and investigators who are eager to participate in clinical trials (2). As well as financial incentives, participation in clinical research projects can also facilitate professional career development for researchers, as they are given the opportunity to research new areas of medicine, test modern standards of treatment, exchange information with foreign medical experts and publish their findings in respected international journals.

A large number of investigators have received GCP training due to their participation in clinical trials and awareness of ICH-GCP standards are steadily increasing among the medical profession.

Investigators know that producing high quality clinical work with attention to detail will encourage more studies to be placed in Poland (3).There is also a sense of pride in the Polish healthcare system as physicians are fully aware of the stigma attached to operating in an emerging health environment.

Cost-Competitiveness
There are cost differentials between western and eastern Europe in terms of fees and operational expense. Ease and speed of patient recruitment play a strong part in affecting this cost differential. Faster patient recruitment allows for costs to be significantly lower for studies conducted in Poland, and therefore there are less costs transferred to the sponsor. Eastern Europe remains competitive and overall trial costs are lower than those in western Europe (2).

Quality
Poland offers good quality data. Audits conducted by the FDA in eastern Europe have confirmed that the quality of the studies conducted in the region is very high (2). Staff are familiar with how to conduct a study and compliant with procedures. In addition, accurate document management highlights the level of control and understanding in following the study design and management of the investigational products. These may include, for example, instrument read-outs, instrument calibration and maintenance documents, temperature recording, correct storage, investigational product accountability records and so on.

Ensure EU Standards
When Poland joined the EU in May 2004, all duties of a full member state were adopted, including certain quality requirements of the legislative framework as well as general state administration (3). When EU standards apply, sponsors have a positive perception of how a country can conduct clinical trials. Poland is expected to implement and adopt all legal requirements resulting from any EU Directive amendments. In alignment with this, Poland has incorporated and established ICH-GCP rules into clinical trial procedures.

Challenges Ahead

While the quality of clinical trials conducted in Poland is high, the key operational and regulatory issues lie within the administrative procedures and transparency of processes. Although the EU CT presents important advantages in terms of ensuring a uniform standard of conducting clinical trials, varying interpretations of some of its terms (legal representative, approval guidelines, drug safety reporting guidelines), highlights that close management is crucial. To ensure success when conducting clinical trials in Poland, it is wise to stay away from inexperienced sites, sites overloaded with studies, or sites where there are English language problems (3,4). It is also important to establish how studies are actually going to be run in Poland and to be clear as to who will be ultimately responsible for the trials, as well as to provide a clear allocation of roles and responsibilities.

Strategic Alliances in Poland

The pharmaceutical industry has experienced a number of changes in recent years.Pharmaceutical and biotech companies are demanding more from CROs due to increasing pressure of timeto- market, patent expiry, constant cuts to development times and reduction in development costs.CROs in turn need to be proactive in their response to the needs of the sponsor by offering a breadth of services, a commitment in terms of risk sharing, and an innovative approach.

Due to the current state of the industry, life science organisations view alliances as an essential part of their organisation’s growth strategy. For a clinical trial to be executed well, it is important to establish a close relationship between all stakeholders, particularly when branching out into eastern Europe. Choosing the right partner is essential for success, particularly when looking to conduct studies in Poland, and it is important to understand how a CRO will conduct and manage a study abroad.A strong local presence and expertise is important, and having an alliance with an experienced organisation is one of the most important pieces of the puzzle.

Conducting early phase clinical trials in particular can be seen as a risky venture from a sponsor’s point of view as they require experienced sites and access to a pool of patients. A strong alliance therefore is a prerequisite for clinical trials to be executed efficiently and in-line with required procedures. Establishing a local presence in Poland by having a specific contact person who can facilitate and standardise cooperation will bring greater efficiency to the process.

Conclusion

Setting up clinical trials in Poland does come with its challenges. Processes and procedures need to be understood, and timelines should be as transparent as possible. By forming a strong alliance with a local presence in Poland, a CRO can extend its service offering and conduct studies in patients, where it would otherwise be extremely difficult or virtually impossible in western Europe. In addition, an alliance with a local presence in Poland will ensure that regulatory and legal procedures are followed closely.

The increasing need for patients at a much earlier stage in the clinical development programme poses challenges. Poland offers access to a substantial pool of patients willing to take part in Phase 2a type clinical trials that would otherwise be extremely difficult to recruit.Working with a CRO that can access such patients through a unique alliance offers the expertise, experience, quality and safety of conducting exploratory clinical pharmacology studies with a smooth transition into specialised populations.

References
  1. Litynski G and Nicolescu R, A Pocket Guide to Clinical Research in Poland & Romania, CR Focus 18(6): pp26-28, 2007
  2. Cantini L and Colazzo S, Look East, European Pharmaceutical Contractor, December 2009
  3. PricewaterhouseCoopers, Clinical Trials in Poland – Key Challenges, November 2010
  4. DeMuro PR and Jaeger-Lenz A, How to Conduct Clinical Trials in the EU and Eastern Europe: Overview and Comparison with the US System, Journal of Health Care Compliance: pp21-26, 2008

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Basia Kondratowicz is the Senior Business Development Executive at Simbec Research Ltd (an Altasciences Company), a specialist in early phase studies. Basia is the ‘champion’ for the unique alliance between Simbec (UK) and Bonne Santé (Warsaw) ensuring successful conduct of early phase studies in patient groups in Poland. Basia joined Simbec in January 2011, bringing 10 years of experience of working in the drug development industry, predominantly in preclinical and early phase clinical studies.
spacer
Basia Kondratowicz
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Sphere Fluidics Closes a $4.8 million USD (£3.7 million) Funding Round

Cambridge, UK, 10 June 2019: Sphere Fluidics, a company commercializing single cell analysis systems underpinned by its patented picodroplet technology, announced today that it has closed an additional tranche of investment of $2.9 million (£2.2 million), securing a total of $4.8 million (£3.7 million) in investment. The funding will be used as working capital for the Company’s Cyto-Mine® Single Cell Analysis System, expansion of the UK facility and enable the doubling of personnel through the opening of a new US Sales Office and Demo Lab in California.
More info >>

White Papers

PROTEIN:PROTEIN INTERACTION ANALYSIS

IBA GmbH

Groth et al., 2007 and Jasencakova et al., 2010 Protein:protein-interactions (PPI) govern almost all important processes in living organisms. Thus, their rapid and accurate determination and investigation is a major challenge in life sciences. The extremely efficient and fast One-STrEP (Twin-Strep) system is suitable for the isolation of functional protein complexes and subsequent mass spectrometry analysis leads to the identification of protein complex components (Junttila et al., 2005) as it is shown in the following studies.
More info >>

 
Industry Events

Nordic Life Science Days 10/12 September 2019

10-12 September 2019, Malmo Sweden

Nordic Life Science Days is the largest Nordic partnering conference for the global Life Science industry. Bringing together the best talents in Life Science, offering amazing networking and partnering opportunities, providing inputs and content on the most recent trends. Nordic Life Science Days attracts leading decision makers from the Life Science sector, not only from biotech, pharma and medtech but also from finances, research, policy and regulatory authorities.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement