Benefits Of Russian Clinical Research Leach


Published on

Article about Clinical Research in Russia

  • Be the first to comment

  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

Benefits Of Russian Clinical Research Leach

  1. 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, supportingclinical 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.1international 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. 2. Clinical Trialsspeciality training. Then, at five-year intervals, Recruitmentevery physician must take a refresher exam tocontinue their practice. Given the overall healthcare situation of Russia, it is not difficult to understand why patientIn addition, since 1991, Russian physicians have enrollment continues to be so strong. Typically, thetravelled throughout the world attending workshops treatment provided in clinical research is better thanand conferences to better understand Western the standard of care available through the nationalmedicine and practices. health services.The result is a highly professional and educated The protocol requirements for complete physicalsinvestigator pool motivated by both financial and and more personal interaction with the investigatormedical necessity to introduce clinical research to as may in itself offer incentive enough to join amany patients as possible. trial. Combined with the additional incentives of Western medicines and therapies, it is easy toIn recruiting and treating patients, the Russian see why the prospective patients are excitedinvestigators have learned to follow good clinical to participate.practices (GCP) and the International Conferenceon Harmonization (ICH). Russia first adopted laws Patients in Russia are both eager to participate andfor governing clinical research in 1998 with the extremely compliant. Most patients are eitherFederal Law on ‘Medicinal Products’ # 86-FZ employed or retired with a high school educationdated 22 June 1998 (with amendments dated 2 and making an average income.4 This mix speaksJanuary 2000 and 30 December 2001). In 1999, to an educated patient population that hasthey incorporated ICH GCP guidelines into law decided to participate because of a specific medicalwith 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 treatmentand further defined the law in 2003 with the as directed.Decree of the Minister of Health of RF #266 dated19 June 2003, entitled ‘Good Clinical Practice in Russian Healthcare SystemRussian Federation’. Though currently plagued with funding challenges,Regulatory inspections by the US Food and Drug the Russian healthcare system still administers care toAdministration (FDA) of 23 investigator sites from millions of Russians daily. Their ‘Soviet’ structuredJanuary 1994 to March 2002 in Eastern Europe, central healthcare system created large medicalincluding Russia, found all the sites to be without institutions specialising in specific therapeutic areas.need of official action.2 These institutions, both general and therapeuticallyAn article in CenterWatch in spring 2004 speaks aligned, have large patient pools to draw fromdirectly to the regulatory environment and quality making enrollment in clinical trials very accessibleof data in the CEE and Russia. “Regulatory to the patient and rapid for the sponsor. Inapproval times across regions are comparable with addition, many of the medical practices inthose in the EU and the quality of data coming from Russia call for hospitalisation, when in the WestCEE 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. 3. Universal Benefits of Russian Clinical ResearchHospital costs, as part of standard practice, do many local CROs that can provide significantnot add to the trial expenses. The additional level savings in clinical fees. Experienced regionalof 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 stillthe opportunity to more closely monitor and providing experienced MDs as project managersinstruct the patients early on helping to facili- and monitors.tate compliance. Everyone BenefitsIt is Russian law that all patients enrolled in clinicaltrials receive an individual insurance policy. The reduced cost of man-hours in addition to theWithout proof of insurance for all patients, no increased enrollment rates provides a greatstudy will be approved. This insurance is important potential for savings. The current economic state ofin protecting the patients’ rights. The cost for this Russia, struggling with change as they adapt to theinsurance is minimal when compared with the cost Western ideas and culture, combined with theof the trial and helps with enrollment, giving needs of the population praying for economicpatients more piece of mind. stability, and in desperate need of improved healthcare, makes the Russian Federation a perfectCost-saving Opportunities platform for clinical research.In addition to the clinical benefits of working in In Russia, Western companies are free to investRussia, there are cost-saving opportunities. Man- their research dollars where they will bring thehours are much less expensive in Russia than in the greatest returns in the shortest period of time. AsWest, so labour can be found at significantly they invest in research, they are also investing inreduced rates. the healthcare of an entire population. These dollars can help stabilise an economy thatAlthough some Russian CROs have begun to ultimately will join the world as a partner and withglobalise, and are realising the financial it bring Russia’s vast resources, both natural andresponsibilities of that growth, there are still cultural, to the world. ■
  4. 4. General InformationThe recent growth in pharmaceutical development in the Russian Federation, Bulgaria, Romania and theUkraine has attracted the attention of drug development companies all over the world. Pharmaceutical andBiotech companies along with numerous international clinical research organizations have seen the valueand have invested heavily. Everyday new offices are opening and trials are being initiated. Though thisgrowth can be attributed to many things from the globalization of research to increasingly friendlyregulatory 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 millionpeople. In major cities like Moscow, St. Petersburg, Novosibirsk, Sofia, Kiev and Odessa there arenumerous 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 thepopulation 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 regulationsas 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, Russiathroughout the region by indication and experience. Our pre-qualificationprocess includes a review of ICH/GCP as well as local law for each site, todetermine if additional training is required.Our monitors and project managers are all certified clinicians experiencedin clinical research. Their relationship with each of their sites is strong andbased on mutual respect. As an organization, GCT maintains strongongoing relationships with the investigators and officials in the Ministry ofHealth. These relationships help us to develop reliable feasibilities and stayabreast of the changes in governmental regulations and their impact onclinical research. Our expanded logistical services helps ensure smoothand timely receipt of study materials and can also coordinate the shipmentand storage of laboratory and PK samples. As your “In Country Advocate”,GCT will represent your organization with the kind of professionalism andattention to detail you would expect from your own team, except with theregional knowledge and local experience that can only come from years ofworking within the Region. Please call us and discover the “GCTExperience” for yourself, you won’t be disappointed. St. Petersburg, RussiaContact: Richard Leach Moscow, Russia Sofia, BulgariaPhone: (609) 731-2225 Kiev, Ukraine Bucharest, Romania Princeton, USA
  5. 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 CROPhone: 609-731-2225