OCT has taken part in the “Partnerships in Clinical Trials – Russia-CIS & MENA-Turkey” conference that was organized by Informa Lifesciences in Istanbul, Turkey on May 22-23 2013.
OCT was represented by Anna Davydova, Business Development Manager, who was holding a speech on a timely topic "Ensuring Fast Patient Enrollment by Placing Clinical Trials in Russia and Ukraine" during the event.
During her presentation, Anna has touched upon very important issues and gave answers to the questions regarding placing clinical trials in emerging markets like Russia and the CIS countres, which are widely discussed in the pharmaceutical market nowadays.
What Anna started her presentation with is the fact that clinical trial industry is relatively young in Russia and Ukraine and the first international trial had been introduced here in early 1990s. However, the situation has changed dramatically since that time.
Today all leading pharmaceutical companies are represented in Russia and other CIS countries, and their number is still increasing. Traditionally, factors that fuel the growth of the Russian and Ukrainian clinical trial market largely include high patient recruitment rate, reasonable study costs, and good data quality. But for the last few years the Russian clinical trial market has been growing extremely rapidly, thanks to the new Law on Pharmaceutical Products introduced in 2010 and “Pharma 2020” program started in 2011.
In 2007 there were about 300 ongoing international multicenter clinical trials in Russia. By 2011 their number raised up to 524 trials. And by 2012 we reached almost a thousand - 916 new clinical trials were approved by the Ministry of Health. In one year, from 2011 to 2012, the number of trials has almost doubled.
By 2014 the clinical trial market in the CIS countries is expected to exceed 700 million Euro.
Due to the escalating costs of bringing a drug to market, many pharmaceutical companies need to develop drugs more quickly and cost effectively. One of the driving factors in global expansion of trials is that in the leading developed clinical trial markets of the United States and European Union, almost half of all trial delays are caused by patient recruitment problems. Enrollment is a factor that most certainly determines the cost and duration of a clinical trial.
According to a survey conducted by one of pharmaceutical experts the average cost of placing a trial in Russia or Ukraine is twice lover compared to the US and German costs.
And there are several factors that make those two countries so attractive financially:
Besides, Russia and Ukraine are more cost-effective due to lower vendor costs and almost twice lower hourly rates of the CRO specialists compared to those in the US. Lower Investigator grant expectations also ensure cost savings in Russia and Ukraine:
Anna has also marked that, while, indeed, placing a clinical trial in Russia or Ukraine is more cost-effective, high quality is one of the most distinguishing factors accelerating the market growth in the region. And, after 20 years of clinical research, the discussed countries have gained solid reputation in conducting quality clinical research.
The highest number of FDA inspections among all the emerging markets was held in the CIS countries - 82 FDA inspections since 2005. Moreover, the CIS countries held the highest in the world percentage of NAI (No Action Indicated) inspections with no objectionable findings observed.
The reason for such level of quality of services connected with clinical trials conduct in Russia and Ukraine is, first of all, GCP being a national standard in both countries. Moreover, the qualifications of MDs in the region are high due to the specifics of the educational system: in Russia MDs must complete 6 years of medical school, followed by 1-3 years of residency, and be re-certified every 5 years.
The second part of Anna’s presentation was devoted to fast enrollment in Russia and Ukraine and ways to ensure high enrollment rates in the region.
1) To ensure fast enrollment a thorough country-level feasibility work must be done. When considering placing a trial in CIS region, one should make sure that there is a population of patients with target disease.
Anna spoke about four main points to keep in mind while planning trials in the CIS countries.
First of all, whether the disease under study is relevant to the patient population?
The study of the disease prevalence in the region will give the general idea of the trial feasibility. Due to the statistics presented by Anna, Russia and CIS countries seem to be a perfect place to conduct trials in different popular therapeutic areas.
Second, is the study Design and comparators acceptable?
A comparator drug must be registered in the country. Since not all the drugs being the standard of treatment in western countries are registered in Russia or Ukraine, not every trial is suitable for the region. Even if the drug is registered, it might not be a standard of care in the CIS region. Another major factor in protocol design acceptability is a specific equipment availability at sites.
Also anticipated regulatory and ethics challenges must be kept in mind.
Such challenges as phase I studies in healthy volunteers, pre-clinical studies for generics, absence of scientific advice procedure, absence of national guidelines on development of particular types of drugs, such as biosimilars, and particular disease, such as diabetes, have been disused by Anna.
The last question to remember is the general timelines for study approval and site start-up.
Although the enrollment timelines are quite short in the CIS countries, longer startup period might make some early-stage trials less reasonable. Enrollment will still be high, but the general study timelines might be comparable to traditional markets. Thus, late-stage trials are the ones that fulfill the potential of such countries as Russia and Ukraine.
In the end of her presentation Anna showed the enrollment rates of a Phase III study in Ovarian cancer. The participation of such countries as Russia and Ukraine was the key to success in this trial where over 700 patients were enrolled in a 3,5 year timeline. 80% of the enrollment was done in Russia and Ukraine.
This case study clearly showed that to fully use the potential of the emerging market the right drug must be offered to the right patients in the right countries.