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International Clinical Trials
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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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