CLINICAL RESEARCH |
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Why patient enrolment in Russia and Ukraine is up to 25 times higher than in the West
David Passov, ClinStar
It is a well known fact that most clinical trials do not meet their original timeline and budget projections. Most delays can be attributed to slower than anticipated patient enrolment. Different strategies have been adapted to mitigate the risk of slow patient recruitment.
One approach is to contract with specialised, patient recruitment companies to boost enrolment after it has become apparent that the timelines will not be met. A more proactive approach gaining momentum with biopharmaceutical companies is the engagement of high-enrolling geographies during the early planning stages of the trial. India, China, South America and Eastern Europe have proven to be such regions. Of these regions, in terms of patient enrolment, Eastern Europe remains the leader with Russia and Ukraine consistently out-performing its neighbours. In this article, we will examine the five major reasons that patient enrolment rates are up to 25 times higher in Russia and Ukraine than in the West. These are:
- Huge patient populations and drug-naïve patients;
- Trials are viewed as an opportunity by patients;
- Vertical and centralised healthcare system;
- Highly qualified and motivated physicians;
- Less competition for investigators.
Now let us examine each one of these in more detail.
Huge patient populations, including drug naïve patients (see figure 1 and 2): Russia and Ukraine span 11 time zones and have a combined population of 200 million people. There are about 20 cities with populations exceeding one million people. |
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Unfortunately, people in Russia and Ukraine tend to be less healthy than their Western counterparts. Furthermore, a large percentage of the population remains naïve about the effects of the newer medications. In the West, for example, it is almost impossible to find rheumatoid arthritis subjects who are unaware of the effects of disease modifying drugs such as Enbrel, Remicade and Humira, while in Russia and Ukraine, almost all patients are.
Patients see trials as an opportunity: In the US and Western Europe an overwhelming majority of people have good private or state health insurance and see no personal advantage from participation in clinical trials. By contrast, people in Russia and Ukraine see clinical trials as an opportunity. Study subjects in Russia and Ukraine frequently receive access to functional diagnostics as well as drugs that would otherwise not be affordable; in other words, they receive much better medical care as participants in a clinical trialVertical and centralised healthcare system (see figure 3): As illustrated in the diagram, patients can be channeled through the system beginning with the polyclinics (multi-functional outpatient facilities) and diagnostic centers through to the specialised therapeutic centers and national research centers. Coupled with excellent databases, the identification of potential study subjects is fast and easy. For example, the Russian Oncology Research Centre located in Moscow has 1,000 cancer beds and sees over 100,000 cancer outpatients per year. A sponsor can often get more patients from one site in Russia than it can obtain from 10 sites in the West.
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Highly qualified and motivated physicians: With the fall of the Iron Curtain and the end of isolation, Russian and Ukrainian doctors became very eager to participate in the cutting edge of Western medicine. They highly value the chance to communicate with their Western peers as investigators in clinical trials. The physicians who participate in clinical trials are highly qualified specialists and recognised members of international medical societies. They are very eager and enthusiastic to participate in international clinical trials, familiar with the latest developments of medicine and have experience working with up-to-date diagnostic methodologies.
As the compensation the physicians receive for practicing medicine is usually less than their Western counterparts, the grants they receive as investigators in clinical trials are proportionately more important
Less competition for investigators: There are fewer clinical trials being conducted in Russia and Ukraine in comparison to the West. According to a clinical trials listing service (www.ClincialTrials.gov) there are 11,543 active on-going clinical trials in the US and 4,984 in Western Europe versus only 302 in Russia and 105 in Ukraine.
High enrolment is worthless without high quality
According to various sources, the quality of data from Russian and Ukrainian sites is as good, if not better, than the quality emerging from the sites in the West. The US Food and Drug Administration (FDA) has published the results of 39 site inspections in Russia and Ukraine. A designation of “No Action Indicated” (NAI) was reported 21 times (54%), “Voluntary Action Indicated” (VAI) 17 times (44%), and “Official Action Indicated” (OAI) only one time (2%). In the US and Western Europe, OAI was reported by the FDA in 7% of the cases, suggesting that the data quality in Russia and Ukraine is better than in the West.
Example (see figure 4)
All the factors described in this article contribute to enrolment rates in Russia and Ukraine that are much higher than in the West. The graph below illustrates the comparative enrolment rates that ClinStar, a CRO in Russia and Ukraine, was able to achieve in Russia and Ukraine for eight different studies conducted for one major pharmaceutical company. Depending on the study, the enrolment at Russian and Ukrainian sites was two to 25 times higher than at Western sites participating in the same study.
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Conclusion
The key phase of any clinical trial is the patient enrolment period. The biopharmaceutical industry could benefit significantly by proactively evaluating Russia and Ukraine as possible locations for their trials during the initial study planning stage. Statistics, as well as experience of numerous biopharmaceutical companies, support the assertion that conducting clinical trials in these two countries reduces the enrolment period, averts the additional outlay of valuable time and money, and optimises the drug development process.
David Passov
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David Passov, ClinStar’s Vice President of Commercial and Clinical Operations, was born in Estonia when it was part of the Soviet Union. He attended Tartu University Medical School in Estonia prior to moving to US in 1993. He received a degree in biology from Boston College and a following short basic science research tenure at Massachusetts General Hospital’s neuroscience department entered the biopharmaceutical industry in 1996. Since that time, he has held positions in clinical operations, project management, market research, business development and commercial operations at various small and large US CROs. Mr Passov also received an MBA from the Executive MBA Program at the Northeastern University (Boston, MA) in 2002. In 2005 he joined ClinStar where he has responsibility for all business development, feasibility, and commercial operations activities as well as assuring that the commitments that are made to clients are fulfilled by the clinical operations department. Mr. Passov is a native Russian speaker and spends about 50% of his time in ClinStar’s offices in Moscow.
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