Why should international sponsors look at Central and Eastern Europe (CEE) as locations for their clinical trials? Want to find out more about the advantages of locating your study in this region and partnering with an international CRO which has 16 years of experience across CEE? Cromos Pharma's CEO Vlad Bogin, MD, FACP
outlines some of the benefits in a recent interview with SOFPROMED
. Read some of the highlights below:
What are some of the main advantages of locating your clinical trial in CEE?
"Central/Eastern Europe boasts a large patient population, tremendous recruitment, motivated investigators, compliant patients and high data quality. And all of this comes with a significant discount. These are the variables that are hard not to like."
Do these regions operate to international standards and is clinical data generated here accepted by the FDA and EMA?
"One of the most common questions that we are asked by the sponsors is about clinical trial standards and applicability of ICH-GCP. They get relieved when we tell them that in all local jurisdictions the national clinical trial standards are a direct translation of ICH-GCP.
Their next question is often about whether the clinical data generated in CEE is accepted by the FDA and the EMA. The answer is a resounding “yes”. At least 70% of large scale international pivotal trials engage CEE sites and often have a bulk of patients recruited there."
Which CEE countries are leading the way with regard to numbers of clinical trials?
"Based on the data from clinicaltrials.gov and clinicaltrialsregister.eu the most prolific countries in clinical research are Poland, Hungary and Russia. I am happy to say that we are successfully operating in all of them."
What about start-up timelines?
"Overall, timelines are very competitive with WE and are much more palatable that many other regions that we compete with."
Any other advice?
"Not all trials should include CEE, but at least 90% should. Neither blind optimism nor the outright dismissal are the right attitudes towards this very attractive region. Carefully select the right service partner, make sure that you are receiving the correct information and do your own SWAT analysis. And 9 times out of 10 the benefits would outweigh the risks."
If you would like to find out more about how Cromos Pharma can support your next projects email email@example.com