Central and Eastern Europe (CEE) is a current hotspot for clinical trial operations. There are many factors that make this region an attractive site for clinical trials, but there are some challenges to overcome too. We've been talking to experts in the region to uncover the difficulties they face.
1. Complex regulatory systems
Each CEE country has different processes and documents to be completed in order to gain regulatory approval for clinical trials. Those new to the region often experience difficulty in navigating the regulatory complexities and keeping up with regulatory changes across the many countries, which can sometimes result in delays.
2. Import/export procedures
Much like the clinical trials regulations themselves, countries within the CEE have differing import and export rules, particularly with respect to the movement of experimental medicines. Operators who do not understand the import/export regulations of specific countries may face delays in the event of non-compliance.
3. The need (and competition) for local knowledge
Due to the complexities detailed above, most companies operating clinical trials in CEE have a need to employ knowledgeable local professionals to ensure that their clinical trials run smoothly and regulations are adhered to. At times, there can be difficulties in employing reliable and experienced local players, and with demand increasing for local staff, finding and keeping good, solid partners is becoming particularly important.
4. Culture, communication and infrastructure differences
Although infrastructure in CEE is continually developing and improving, at times there can still be difficulties with transportation to trial sites, and obtaining visas can add to costs. Those operating clinical trials in CEE also need to be aware of cultural and language differences, in order to avoid miscommunications. In some CEE countries, corruption can still be an issue to be wary of.
5. Patient recruitment strategies
Although CEE has a large, treatment naive patient population, the population of each individual country is not nearly as significant as countries such as Germany or the USA. Therefore, when designing clinical trials it is important to ensure that trials are located at sites where high patient recruitment is expected, and that solid patient recruitment strategies are implemented in order to allow timely recruitment of good patients.
Think we've left off some challenges? Are you an operator in the region who has some solutions? Feel free to comment below, or check out our new event, BioPharma CEE Convention 2013, and see also 5 Advantages of Operating Clinical Trials in CEE.