Article about Clinical Research in Russia

1. Clinical Trials
Universal Benefits of Russian Clinical Research
a report by
Richard Leach
Overview diseases. When left untreated or inadequately
treated these diseases may cause sterility. In
Investment in clinical research in Central and addition, the high incidence of cardiovascular
Eastern Europe (CEE) and Russia has continued to disease combined with growing regional
grow at a rapid rate. Over the last few years epidemics in HIV and hepatitis impact dramatically
international pharmaceutical companies and Russia’s ability to effect significant change to the
contract research organisations (CROs) have mortality rate.
expanded their local presence significantly to take
Richard Leach is Vice President advantage of research opportunities while reducing Over the last 40 years cardiovascular disease (CVD)
and Head of Business Development the cost of their clinical programmes. Although and stroke mortality rates in Japan, Western
for Russian Clinical Trials, LLC, a
regional contract research large pharma may also be setting up the Europe and North America have fallen very
organisation (CRO) located in St infrastructure to take advantage of the long-term sharply. In the US, for example, the age-adjusted
Petersburg, Russia, supporting
clinical research throughout Russia,
market potential, the near-term returns on the decline between 1965 and 2000 was over 56%.
the Ukraine and Bulgaria. Prior to clinical opportunity are apparent. Russia, by contrast, suffered an explosion of
joining Russian Clinical Trials, Mr cardiovascular deaths over the same period.
Leach was Director of Business
Development for PharmaNet, For years, Eastern Europe has been a fertile ground Between 1965 and 2001, Russia’s age-standardised
responsible for developing for clinical research due to excellent patient access death rate for CVD surged by 25% in women and
corporate relationships with key
and a motivated and experienced investigator by 65% in men.1
international accounts. Over his 15
years in the pharmaceutical base. Now, the new CEE countries that have been so
industry, he has worked with effective are in the process of redeveloping The increase in cardiovascular mortality has been
companies offering international
services as diverse as centralised their research standards to address the new EU attributed to stress brought on by the social and
laboratory and electrocardiogram Clinical Directive. economic changes, alcoholism, which is on the
(ECG) monitoring to regulatory rise in both men and women, tobacco smoking
support and project management.
Prior to his position at As these CEE countries move towards compliance and a more sedentary lifestyle with very little focus
PharmaNet, Mr Leach held with the new directives, sponsors and CROs alike on any exercise other than walking. Because many
numerous positions with Covance
Labs, Premier Research and
have increased their interest in Russia. of the elements associated with the surging
Quintiles Late Stage Development. mortality rate are connected to social behaviour
Russia Today and the need for education, there is little hope
that the government, with its regionally limited
The Russian Federation is a country of 145 million medical infrastructure, will be able to incorporate
people. Although about 65% of the population live enough changes to slow or stop the trend in
in industrialised cities with access to government- the near future. This environment, though bleak
sponsored medical care and treatment centres, the for Russia’s future, creates significant opportunity
country has been mired in a negative population for companies who want to help be part of
growth for over 10 years. the remedy.
The National Bureau of Asian Research (NBR) has Quality Medical
reported that in the 11 years since post- Care and Data
communism independence, “Russia’s population
has declined by more than four million people or Despite the medical care of the average Russian
about 3%”.1 This decline has been attributed to being in need of improvement, the expertise and
numerous causes, the most dramatic being knowledge of the doctors treating them is very
lower birth rates as a result of increased abortion highly regarded. Doctors in Russia must undergo
rates, and the spread of sexually transmitted medical school followed by residency and
1. Eberstadt N, “The Russian Federation at the Dawn of the Twenty First Century” NBR Analysis, Volume 15, Number
2, September 2004.
BUSINESS BRIEFING: PHARMA OUTSOURCING 2005

2. Clinical Trials
speciality training. Then, at five-year intervals, Recruitment
every physician must take a refresher exam to
continue their practice. Given the overall healthcare situation of Russia, it
is not difficult to understand why patient
In addition, since 1991, Russian physicians have enrollment continues to be so strong. Typically, the
travelled throughout the world attending workshops treatment provided in clinical research is better than
and conferences to better understand Western the standard of care available through the national
medicine and practices. health services.
The result is a highly professional and educated The protocol requirements for complete physicals
investigator pool motivated by both financial and and more personal interaction with the investigator
medical necessity to introduce clinical research to as may in itself offer incentive enough to join a
many patients as possible. trial. Combined with the additional incentives
of Western medicines and therapies, it is easy to
In recruiting and treating patients, the Russian see why the prospective patients are excited
investigators have learned to follow good clinical to participate.
practices (GCP) and the International Conference
on Harmonization (ICH). Russia first adopted laws Patients in Russia are both eager to participate and
for governing clinical research in 1998 with the extremely compliant. Most patients are either
Federal Law on ‘Medicinal Products’ # 86-FZ employed or retired with a high school education
dated 22 June 1998 (with amendments dated 2 and making an average income.4 This mix speaks
January 2000 and 30 December 2001). In 1999, to an educated patient population that has
they incorporated ICH GCP guidelines into law decided to participate because of a specific medical
with the passing of OS 42-511-99 ‘Rules of need. These patients tend to make all the
As these CEE countries move towards compliance with the
new directives, sponsors and CROs alike have increased
their interest in Russia.
Clinical Trials Conduct in Russian Federation’, planned appointments and comply with treatment
and further defined the law in 2003 with the as directed.
Decree of the Minister of Health of RF #266 dated
19 June 2003, entitled ‘Good Clinical Practice in Russian Healthcare System
Russian Federation’.
Though currently plagued with funding challenges,
Regulatory inspections by the US Food and Drug the Russian healthcare system still administers care to
Administration (FDA) of 23 investigator sites from millions of Russians daily. Their ‘Soviet’ structured
January 1994 to March 2002 in Eastern Europe, central healthcare system created large medical
including Russia, found all the sites to be without institutions specialising in specific therapeutic areas.
need of official action.2
These institutions, both general and therapeutically
An article in CenterWatch in spring 2004 speaks aligned, have large patient pools to draw from
directly to the regulatory environment and quality making enrollment in clinical trials very accessible
of data in the CEE and Russia. “Regulatory to the patient and rapid for the sponsor. In
approval times across regions are comparable with addition, many of the medical practices in
those in the EU and the quality of data coming from Russia call for hospitalisation, when in the West
CEE sites is also superb, as indicated by both internal the same treatment may be done in an out-
BMS audits and FDA inspections”.3 patient setting.
2. Platonov P, “Clinical Trials in Russia and Eastern Europe: Recruitment Quality”, Int. J. Clin. Pharmacol. Ther.
Vol. 41, No 7, 2003 pp. 277–280.
3. Borfitz D, “Expanding Opportunities in Eastern Europe” CenterWatch Monthly, Volume 11, Issue 4, April 2004.
4. Varshavsky S, Platonov P, Kistkina M, “Why Do Patients Participate in Trials?”, GCPj November, 2002.
BUSINESS BRIEFING: PHARMA OUTSOURCING 2005

3. Universal Benefits of Russian Clinical Research
Hospital costs, as part of standard practice, do many local CROs that can provide significant
not add to the trial expenses. The additional level savings in clinical fees. Experienced regional
of attention is helpful in informing the patients CROs can provide savings upwards of 50%,
of their obligations in the trial and providing compared with those in the West, while still
the opportunity to more closely monitor and providing experienced MDs as project managers
instruct the patients early on helping to facili- and monitors.
tate compliance.
Everyone Benefits
It is Russian law that all patients enrolled in clinical
trials receive an individual insurance policy. The reduced cost of man-hours in addition to the
Without proof of insurance for all patients, no increased enrollment rates provides a great
study will be approved. This insurance is important potential for savings. The current economic state of
in protecting the patients’ rights. The cost for this Russia, struggling with change as they adapt to the
insurance is minimal when compared with the cost Western ideas and culture, combined with the
of the trial and helps with enrollment, giving needs of the population praying for economic
patients more piece of mind. stability, and in desperate need of improved
healthcare, makes the Russian Federation a perfect
Cost-saving Opportunities platform for clinical research.
In addition to the clinical benefits of working in In Russia, Western companies are free to invest
Russia, there are cost-saving opportunities. Man- their research dollars where they will bring the
hours are much less expensive in Russia than in the greatest returns in the shortest period of time. As
West, so labour can be found at significantly they invest in research, they are also investing in
reduced rates. the healthcare of an entire population. These
dollars can help stabilise an economy that
Although some Russian CROs have begun to ultimately will join the world as a partner and with
globalise, and are realising the financial it bring Russia’s vast resources, both natural and
responsibilities of that growth, there are still cultural, to the world. ■

4. General
Information
The recent growth in pharmaceutical development in the Russian Federation, Bulgaria, Romania and the
Ukraine has attracted the attention of drug development companies all over the world. Pharmaceutical and
Biotech companies along with numerous international clinical research organizations have seen the value
and have invested heavily. Everyday new offices are opening and trials are being initiated. Though this
growth can be attributed to many things from the globalization of research to increasingly friendly
regulatory environments one key element continues to drive interest, Patient Availability.
The Russian Federation, Bulgaria, Romania and the Ukraine represent a population in excess of 200 million
people. In major cities like Moscow, St. Petersburg, Novosibirsk, Sofia, Kiev and Odessa there are
numerous hospitals and scientific research centers that are highly-specialized offering hundreds of beds.
Many of these centers are pathology specific and attract patients from the local area (over 70% of the
population live in and around major population centers).
City - Country Population Global Clinical Trials, LLC (GCT) is a Regional CRO with it’s
headquarters located in Princeton, NJ and offices in Russia,
Moscow – Russia 10,000,000 Bulgaria, Romania and the Ukraine performing clinical research
St. Petersburg - services across Eastern Europe. GCT is experienced supporting
4,500,000
Russia trials across all phases of research and therapeutic areas; working
Kiev - Ukraine 3,000,000 with international clients from across the globe. Whether you are
looking for full clinical support to include site selection, monitoring,
Bucharest, Romania 2,100,000
project management, Regulatory, import/export, drug storage, and
Sofia - Bulgaria 1,200,000 medical writing; or only interested in an individual service to
All City populations have been rounded to the address an urgent need, you can count on GCT to handle your
nearest 100,000 requirements professionally and completely.
We offer a strong understanding of both local and international regulations
as well as access to 1,000s of qualified sites in numerous therapeutic Church on the Blood.
areas. The GCT data base identifies over 2,800 experienced sites St. Petersburg, Russia
throughout the region by indication and experience. Our pre-qualification
process includes a review of ICH/GCP as well as local law for each site, to
determine if additional training is required.
Our monitors and project managers are all certified clinicians experienced
in clinical research. Their relationship with each of their sites is strong and
based on mutual respect. As an organization, GCT maintains strong
ongoing relationships with the investigators and officials in the Ministry of
Health. These relationships help us to develop reliable feasibilities and stay
abreast of the changes in governmental regulations and their impact on
clinical research. Our expanded logistical services helps ensure smooth
and timely receipt of study materials and can also coordinate the shipment
and storage of laboratory and PK samples. As your “In Country Advocate”,
GCT will represent your organization with the kind of professionalism and
attention to detail you would expect from your own team, except with the
regional knowledge and local experience that can only come from years of
working within the Region. Please call us and discover the “GCT
Experience” for yourself, you won’t be disappointed.
St. Petersburg, Russia
Contact: Richard Leach Moscow, Russia
Sofia, Bulgaria
Phone: (609) 731-2225 Kiev, Ukraine
Bucharest, Romania
Princeton, USA

5. St. Petersburg, Russia
Moscow, Russia
Sofia, Bulgaria
Kiev, Ukraine
Bucharest, Romania
Princeton, NJ USA
Experience Across Multiple Therapeutic Areas
CNS Oncology / Blood Disorders
Alzheimer’s, Depression, Schizophrenia, Colon, Pancreatic, Prostate, and Breast
Attention Deficit Disorder, Multiple Sclerosis, Cancers, Acute Myeloid Leukemia,
Diabetic Neuropathic Pain Chemo Induced Nausea and Vomiting,
Cardiovascular Ophthalmology
Acute Peripheral Arterial Thrombosis, Hyper- Acute Macular Degeneration (WET and
lipidemia, Congestive Heart Failure, Ischemia, DRY), Subfoveal Choroidal Myopia,
Arteriosclerosis, Coronary Artery Disease Glaucoma, Diabetic Macular Edema
Anti-Infectives Dermatology
Community Acquired Pneumonia (CAP), AIDS
ACNE, Psoriasis, Rosacea, Herpes
HIV Induced Diarrhea, Hepatitis C,
simplex
Streptococcus pneumonia, Helicobacter pylori
(H. pylori), Urinary Tract Infections
Metabolic / Endocrinology Other Studies
Type I and Type II Diabetes, Diabetic Foot Surgical Pain, Acute Viral Rhinitis,
Ulcer, Rheumatoid Arthritis, Osteoporosis, Stomach Ulcers, Gastric Intestinal
Gastroenterology, Diabetic Neuropathy Reflux
Testimonials:
“Our organization didn’t have experience working in this region of the world so our team
was a little anxious. It wasn’t long however before we realized our fears were unfounded.
GCT handled everything professionally and completely. They expedited the regulatory
process and handled the importation of study drug from beginning to end. GCT made our
first experience in Russia a huge success.”
President, US Biotech
“This was our second time working with GCT and they impressed us even more the
second time around. With the deadline looming for submission prior to summer holiday,
GCT worked tirelessly to create the submission package and manage all the translations
necessary for us to get approval on time. From that point on we knew we had a team that
understood the value of time and could get the job done!”
Director, Clinical Operations, US Pharmaceutical Company
“The support GCT provided in helping us get started was incredible. We found the staff to
be very customer friendly, and professional. Our project manager, a cardiologist himself,
knew every detail about the protocol and the patient population. We found GCT
dependable and extremely easy to work with.”
V.P. European Operations, Global CRO
Phone: 609-731-2225 www.gctrials.com