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| The Eastern Europe Advantage |
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According to the inputs provided by a Frost & Sullivan expert in Contract Services Magazine, Europe, though emerging markets will continue to rise, all eyes will be on Eastern Europe as it strengthens its claim to be the new Mecca for cost-effective clinical trials. Spurred by the growing volume of clinical work being outsourced to Eastern European CROs, Europe is poised to maintain its current position as the second largest market for CRO services globally.
Cost benefit and patient availability
One of the key trends in the European CRO market has been Eastern Europe's emergence as a key hub for handling cost-effective clinical trials, whereas Western Europe faces the subdued state of preclinical-clinical research. A weak national economy compounded by rising drug costs and reduced government funds has headed towards a fall in the level of preclinical research in Western Europe. But Eastern Europe is the most promising region for the industry. Relatively easy, quick and cost-effective access to big patient populations are the key drivers behind the region booming for American and Western European pharma companies. The large percentage of clinical trial costs related to patient compensation is an issue, driving clinical development from West to East, especially large scale and/or multiple trials are required. With limited access to new medicines, patients in Eastern Europe are keen on participating in studies that allow them access to novel drugs. Combined with a record of excellent patient compliance with protocols, the outcome is high-quality data and a speedier regulatory approval. |
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What are the advantages of conducting clinical trials in CEE?
- High patient recruitment rates
- Low drop-out rates
- High percentage of treatment-naïve
patients compared to Western
Europe or USA
- Centralised and urbanised healthcare
system and hospitals with direct access
to large patient populations
- Very good medical education and
professional qualification of physicians
and nurses
- Good quality of data and documentation
- Favourable regulatory framework and
local legislation adapted to international
guidelines
How are language differences handled in clinical trials in CEE? Do all the investigators speak English?
Due to the language diversity of CEE, translations are one of the issues that should be carefully considered in time and costs planning. Information for patients and consent forms need to be customised to local regulations and translated into local language(s). Customisation and translation is also required for contracts and labels. A synopsis of the clinical study protocol should be translated into the local language. In some cases RA or EC might request translation of selected information from the clinical study protocol or IB (e.g. if the submitted translation of the synopsis does not provide complete information on inclusion/exclusion criteria or safety issues).
How long does it take from submission to approval of a clinical trial by RA and EC(s) in the Ukraine?
Under current Ukrainian regulation the maximum time from submission of the study documents to receipt of approval is 60 days in general cases. Submission to CEC can be done in parallel to SPC and then does not delay the study approval.
For certain types of studies (e.g. gene therapy) the regulatory and ethics review can be extended.
Additionally, approximately 2 weeks should be added for application for and receipt of permissions for importing and exporting study materials (import/export licenses).
How are clinical trial contracts handled in CEE? Who is/are the contract party/parties?
Usually two contracts, one with the clinical trial site and one with the principle investigator, should be negotiated and signed at the start of a clinical trial. Particular attention should be paid to customising the contract texts to local requirements and translation and organisation of payments according to procedures permitted by local legislation. |
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How much can Sponsors save on costs when conducting clinical trials in CEE?
Low costs are often used as a misleading argument to promote CEE. In fact, the cost items in clinical trial budgets are quickly catching up with those in Western Europe. Thus, investigators fees, regulatory costs, project management and monitoring costs do not differ much. Some costs, e.g. those related to import/export procedures, might be even higher in CEE.
It is more important though to consider and compare the costs per patient, rather than general budget per country. In this respect CEE countries with high patient recruitment and low drop-out rates have a significant advantage. Sponsors can save up to 50% of their clinical trial budget when conducting clinical trials in CEE.
How is the RA and EC review and approval process organised in the Ukraine? Are there any specific requirements to submission documents?
Legislation is adapted to international standards. ICH GCP is incorporated into national legislation. Ethics committees work according to international standards.
National Regulatory Authority – State Pharmacological Center (SPC) – meets monthly to review initial applications for clinical trials.
At the end of 2009 the new Order of the Ministry of Health on Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials and Model Regulations of the Ethics Committees has come into force. This improved understanding of clinical trial process and clarified several items which were poorly described in earlier regulations.
Ethics review and opinion is to be requested from one central Ethics Committee (CEC). CEC’s opinion is valid for all the sites in Ukraine. Local ethics committees are to be informed about the study by investigators, and provided with copy of CEC opinion.
How is the import/ export of study drugs and clinical trial materials organised in the Ukraine?
After receipt of study approval from SPC and CEC an application for import and export licenses is submitted to SPC. It takes approximately 2 weeks to get the permissions for importing and exporting study materials (import/export licenses).
In countries outside EU, like the Ukraine, customs clearance procedures would require extra time and cost (customs brokers, storage etc.). This is important to consider during initial study planning and to organise the process with knowledgeable local experts.
The selection of courier companies should be also carefully approached as the top courier companies in one country may not necessarily have the same good coverage and high performance in another country. |
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