The growth drivers for clinical trials in CEE are greater access to drug-naïve patients, lower labor costs and other site
fees, higher concentration of patients near sites, and closer relationships between doctors and patients. All this creates
a typical dropout rate of less than 5% compared to 20% in Western Europe. This means that the initial investment to start
a trial, such as the submission fees to ethic committees, give access to a much higher number of potential subjects suitable
for the trial than in Western Europe—consequently, CEE offers more subjects per Euro spent. 
Survey and Article Methods
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It is important to appreciate the role of CROs as drivers into these new markets. Although they cannot directly recruit patients,
they can drive the enrollment and retention in two ways. Firstly, CROs can help sites in the preselection of potential study
subjects since they have their own databases of potential recruits. Secondly, the CRO helps the preselected subjects by offering
them training courses on the trial, vocabulary related to it, questions to ask doctors, and information on their rights to
reduce the time to informed consent. Furthermore the CRO can "brand" the study by providing materials to subjects, such as
calendars, mouse pads, pens, folders with documentation—and these techniques have higher success rates than in Western Europe
or North America. This improves subject retention and speeds up the overall process.
Thus, the geographical reach of CROs (plus the lack of capacity to maintain the services they offer) is driving expansion
into CEE. One global CRO told us that Poland was the "first and most obvious place" to begin its CEE operations. A separate
supplier confirmed that for companies with operations in Eastern Europe, "almost all would have a presence in Poland." In
terms of growth, our understanding is that CEE is growing at about twice the rate of Western Europe—some companies interviewed
use 30% vs. 10% as their assumption. According to one company based in Prague, about 500 trials are approved each year in the Czech Republic. The country is particularly
attractive because every Czech citizen has mandatory health insurance, there is one doctor for every 3.48 patients, there
are 78 medical research universities, and new companies setting up in Czech receive tax relief for 10 years (and can deduct
all R&D costs conducted within the country). Finally, it's important to discuss Russia. The main reason why Russia is distinct from the rest of Europe is that as a non-EU
country there are customs requirements that forbid direct shipments to the investigational sites (such as the need for import
and export licenses). To create economies of scale and reduce the lead time for paperwork this creates a need for subdepots/warehousing,
which can approach 40% of the cost of the logistics for a clinical trial. In addition, some interviewees refer to "unpredictable"
elements in the approval process. Rising complexities CROs are often perceived as a one-stop shop for clinical trials. While small pharma companies and biotechs generally lack
the ability to conduct their own full-scale trials, large companies possess the capability to undertake trials in house. Hence,
major pharmaceuticals will mainly employ CROs when they run out of capacity or require access to previously untapped investigational
sites. To larger sponsors, the CRO is seen as a service provider, and in some instances there will be little direct involvement
from the sponsor for the duration of the trial. Pharmaceutical companies, however, are likely to always retain two activities: protocol development and site monitoring. Protocol
development has significant legal implications and outsourcing it may lead to many potential problems. Whereas with the latter
activity (i.e., site monitoring), direct contact with investigators and sites is the only way that the company can capture
the knowledge generated at the sites. CROs already provided preclinical and clinical trial services, but they are now expanding into broader service provisions:
- Preclinical testing: preclinical safety evaluation, study design, product development
- Project management: taking responsibility for project management throughout the clinical trial process rather than specific
phases
- Sponsor networking: services to provide sponsors for niche projects, such as conferences and other networking events
- Regulatory consulting: ensuring regulatory compliance for a broad area of legislative issues and post-trial approval phase
- Analysis and reports: data collection, statistical analysis, production of results, and reporting to sponsors.
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