There are approximately 1,300 new studies registered annually in the Central and Eastern Europe (CEE) region. Poland, Hungary, and the Czech Republic take the largest share, each with 300 – 400 clinical trial registrations annually. However, it is important to consider the two of the most crucial success factors: start-up timelines and clinical trial quality overall.
START-UP TIMELINES IN THE CEE REGION
The study start-up is a very complex process. At times this phase seems to be bottlenecked especially because many start-up tasks are performed by multiple people, in different locations, and various sites. Delays in the start-up phase are now considered the norm but does this really have to be the case? The answer is no, it doesn’t have to be this way in the CEE Region!
In the CEE Region the Investigators and study teams are motivated to participate in studies. Not only for the therapeutic benefits, but for the scientific opportunities that studies bring, like networking with the international medical community.
At GCP-Service we have a defined start-up team. Our Leaders – top managers from all affected departments – are able to manage all the country and site-specific aspects and work in a very targeted manner to start enrolment in the agreed timelines. For feasibility processes we work with PI-Select, an e-tool that shorten the average time of an investigator’s response from weeks to days. During the start-up process itself we use our own unique tools like a database with individual sites requirements for investigator’s agreements.
Based on the FDA’s publicly accessible Clinical Investigator Inspection List, the analysis of findings and outcome classifications from FDA inspections during Investigational New Drug (IND) studies was published.
Over 230 FDA inspections were conducted within CEE countries. The results indicated that the number of studies where “no deficiencies” were noted were double the number when compared to the findings in Western Europe, and in the USA. Of note, there were 15-26% less Voluntary Action Indications compared to results in developed countries.
Quality is never an accident; it is always the
result of high intention, sincere effort, intelligent
direction and skillful execution. Will A.Foster
Clinical studies in the countries of Central and Eastern Europe have a long history of study experience. The main reasons to CEE sites are the availability of patients with certain health problems that meet the inclusion/exclusion criteria and patients are willing to participate in studies.
At GCP-Service, we connect Western Europe and Central and Eastern Europe and expand the potential for your clinical trial population. By providing a wider population group this helps accelerate recruitment and reach the required number of participants needed. The CEE Region should be considered when options might otherwise be insufficient or more costly if limited to US or Western European sites only.
If you are interested in the topic, please contact us:
Ing. Kristýna Paseková
Head of Clinical Operations CEE
Phone: +420 776 805 805