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International Clinical Trials

Local Impact

Modern-day Russia may have emerged as an attractive location for clinical trials, but delivering study materials safely and meeting the complex importation and customs clearance procedures – especially from a central laboratory perspective – can reduce sponsor enthusiasm about operating in the country.

One solution is to consider locally-based central laboratory networks, which can help ensure high-quality standards and deliver a single database of harmonised lab data from across all facilities in an international and multi-centre clinical study.

Market Value

The main factors behind the significant growth of the Russian trial market in recent years include high patient recruitment rates, competitive overall study costs and good data quality. In 2005, there were only about 440 ongoing trials in the country. By 2012, the number had more than doubled to 915, only to drop to 791 in 2013 – mainly due to fewer studies being initiated by local Russian companies. In addition, the number of trials conducted within the country by foreign sponsors has tripled over the last decade.

Growth is forecast to continue over the next few years. The value of Russia's clinical trial market was around $200 million in 2012; it is expected to surpass the $300 million mark by 2016. Contributing to this is the new federal law, 'On circulation of medicines', which came into force in 2010. This legislation requires trials to be conducted in Russia prior to obtaining any new drug marketing authorisation on the Russian market.

Patient Enrolment

One of the most important reasons to conduct clinical trials in the country is the high recruitment and low drop-out rates. The total number of subjects enrolled in Russian trials last year was 57,609, with the majority of patients – more than 46,000 – enrolled in Phase 3 studies.

Russia offers access to a massive population in excess of 140 million, with a large number of treatment-naïve patients. Some 73% of the population live in large urban areas, and 12 cities have more than one million citizens.

The country has a very centralised healthcare system, with a high concentration of patients in large academic institutions and specialised hospitals that are ideal for trial recruitment. Patients are motivated to participate and disciplined to stay in a trial that offers access to innovative treatment and higher healthcare standards. Russian sites often enrol a targeted number of patients well ahead of schedule, and are frequently asked to recruit additional patients initially planned for other regions.

Quality and Costs

Russia has not had a significant number of FDA inspections in the past, probably because the regulator prefers to audit regions that undertake much bigger numbers of trials. In 2013, the FDA conducted just two clinical trial inspections in Russia, with only voluntary actions suggested. This confirms the high quality of clinical data produced in the country, which is influenced by the well-trained and qualified clinical research associates and other staff involved.

Although investigator fees in Russia are much lower than their US and Western European counterparts – the difference could be up to 50% – additional clinical study costs, such as patient insurance, customs clearance, higher courier charges and the cost of comparators could, in some cases, even the difference of study cost per patient.

All of these factors help ensure good overall completion time of clinical studies run in Russia, and this factor is arguably the overriding attraction for sponsors.

Supply Delays

The main difficulty for Russian trials, however, lies with the logistics of study supplies and biological material. Import and export requirements involve complicated customs regulations which are strictly applied by customs staff. Any issue with a shipment itself or the accompanying documentation can result in material being held in customs. This can cause delays to the study – particularly from a central laboratory perspective – and can curb enthusiasm about Russia.

With the current growth in temperature- and time-sensitive shipments, a strategy to avoid potential hurdles around inter-country logistics is essential. One answer is to contract locally-based central laboratory service providers. In the case of multinational and multi-centre trials, the laboratory should be part of an international network that has capabilities to provide harmonised lab results in one single study-specific validated database.

Decentralised Model

These 'local central' lab networks provide decentralised services to trial sponsors. Laboratories can exchange results instead of exchanging samples, avoiding supply-related costs and delays.

Harmonisation is the watchword of this process. Diagnostics and logistical procedures are carried out in precisely the same way across all central labs across the network. Data are automatically sent from all the local facilities to the database. This integrates comparable results and sidesteps the risk of potential bias generated by technical differences at each individual lab.

A multi-step process can be used to establish and maintain harmonisation of the analytical platform within a network. A reference laboratory is selected to set standard reporting units and common reference intervals. Commutable reference samples can then be distributed across the network. A critical analytes assessment can be performed, and the obtained results are compared to reference lab results. The harmonisation factor can then be determined for each analyte, used to recalculate the results, and entered onto the database. Ongoing analysis of quality control results across the network is key. A harmonised IT platform is also essential to ensure a reliable and clean database from a single source.

The decentralised central laboratory services model provides many benefits for sponsors conducting clinical trials in Russia – in particular, budget and time savings that can increase efficiency through the whole study process, with export and import issues avoided. For instance, fewer inter-country shipments are required as the locally-based central labs provide all supplies and materials, and analyse the samples. Similarly, lab results are made available faster due to shorter specimen turnaround time. Having local support and expertise for investigative site staff and the sponsor team is a further advantage.

Full Potential

Due to the escalating costs of bringing a drug to market, many pharmaceutical companies need to develop drugs more quickly and cost effectively, with patient enrolment a factor that most certainly determines the expense and duration of a trial. Russia is an excellent place for large-scale, fast patient recruitment into studies in all major therapeutic areas. However, the market remains logistically challenging due to regulations, as well as export and import requirements. Local services that operate through a joined-up, harmonised network of central labs is an increasingly necessary step for utilising the full potential of this market.

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Tomasz Anyszek is Director of Synevo Central Labs, where he is responsible for clinical trial operations in over 50 laboratories in Central and Eastern Europe. Tomasz started his career with Virtual Central Laboratory in the Netherlands, and his experience also includes coordinating the activities of 16 regional Covance partner labs across Europe. He holds a PhD from Jagiellonian University, Poland. Prior to his business career, Tomasz taught Clinical Biochemistry and Laboratory Medicine at the University’s medical faculty.

Michal Dysko is Head of Business Development at Synevo Central Labs. He joined the business in 2008 and is responsible for sales and marketing operations of the whole network. Michal has more than 10 years of experience in the clinical research industry from a trial services provider perspective, and obtained an MBA degree from the University of Quebec and Warsaw School of Economics in 2003.
Tomasz Anyszek
Michal Dysko
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