Ict Article Gct Info Mar07


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Article about performing clinical research in Eastern Europe

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Ict Article Gct Info Mar07

  1. 1. ict Global Outsourcing400 A Home for Trials: the Bloc Reborn300 Eastern Europe – a place for experienced sites, motivated patients and a history of success. Richard Leach of RCT Global, LLC, takes a closer look at Russia, the largest, most populated200 member of this research centric region Richard Leach is Vice President and Head of Business Development for RCT-Global LLC, a CRO with offices in Russia, Bulgaria and the US that uses a global network of regional providers to support clinical100 research worldwide. Prior to joining RCT-Global in 2003, Richard was Director of Business Development for PharmaNet, responsible for developing corporate relationships with key international accounts. With over 15 years’ experience in the pharmaceutical industry, he has had the pleasure of working with companies offering international services as diverse as centralised laboratory and electrocardiogram (ECG) monitoring to regulatory support and project management. Prior to his position at PharmaNet, Richard held numerous positions with Covance Labs, Premier Research, and Quintiles Late Stage Development. Eastern Europe continues to be one of the most active regions in both internal BMS audits and FDA inspections: “Overall the world for clinical research. Since the early to mid 1990s, deficiencies were found to be far less common in Central and pharmaceutical companies and the CROs that support them Eastern Europe than in Western Europe. Up to 10 per cent of have run thousands of clinical trials, invested millions of BMS’ global data comes from Central and Eastern Europe. On dollars, and opened or expanded offices throughout the region individual studies, sometimes as much as 50 per cent of the data to accommodate unprecedented growth. Why has growth been comes from this region” (2). so dramatic and what continues to make Eastern Europe the second highest patient recruiting region in the world for ENROLMENT ENVIRONMENT industry sponsored clinical trials, after the US (1)? In order to consider this question we need to first reflect on the history of The reasons for patients within Eastern Europe to participate in this phenomenon, and then examine how these changes affect clinical research are as varied as in other parts of the world. the region today. Table 1: Population Overview of Region RESEARCH PIONEERS Population (rounded to Country the nearest thousand) Research organisations focused on this region initially to Belarus 9,755,000 supplement patient enrolment in trials where recruitment was not Bosnia and Herzegovina 4,499,000 meeting expectations. With a population of almost 325 million, and with large centralised health facilities offering deep pools of Bulgaria 7,726,000 potential patients, the attractiveness of the region was justified. Croatia 5,025,000 Once trials were introduced to the region, these early sponsors Czech Republic 10,265,000 and research organisations discovered site productivity, across all Estonia 1,330,000 therapeutic areas, was consistently higher than either Western Hungary 10,076,000 Europe or the US. As the region developed and more countries Latvia 2,307,000 created central ethics committees, formed solid government Lithuania 3,412,000 oversight and adopted legislation in support of ICH-GCP, more investment poured into the region. However, once the early Montenegro 631,000 research pioneers successfully began submitting data generated Poland 38,128,000 from investigator sites and patients across this region, the level Republic of Macedonia 2,034,000 of interest within the industry soared. Romania 22,304,000 Russia 142,400,000 Many of these organisations are now coming to this region Serbia 9,779,000 because of the bulk of their international patient databases. Slovakia 5,401,000 What they have found is that the regulatory oversight and the Slovenia 2,004,000 commitment to GCP is of the highest quality. According to Cezary Statuch, Executive Director of Global Development Ukraine 46,481,000 Operations for Bristol-Myers Squibb, the quality of data coming Total Population 323,557,000 from Central/Eastern European sites is superb, as indicated by 36 ICT www.samedanltd.com
  2. 2. However, the idea that these patients are Figure 1: Breakdown of trial phases of the approved trialssomehow driven to research due to poverty orlack of knowledge is based on stereotype not 10statistics. In fact, the typical patient is well off, 31with limited medical care and typically suffers 13 70from a chronic ailment that is not beingeffectively managed, or where western Imedicines offer better hope of cure or relief IIthan their current treatment. These patients are IIIhighly literate and have a strong understanding IVof the benefits and risk involved in their Bioequivalenceresearch (3). In Eastern Europe, healthcare is aheavily discussed and much published topic;newspaper articles have served to educate the 104population on new therapies and treatments.Another reason why patients in Eastern Europefind the risk of clinical trials acceptable is thatthe medical profession in Eastern Europe is Figure 2: Breakout of trials by therapeutic areaconsidered to be ethically sound (1). Thisenvironment promotes a much higher level of 60trust between the patients and the investigators. 42 34 31 40 20 20 18CURRENT GROWTH 20 7 9 7 7 6 5 4 5 1 3 2 4 2 1 0Over the last 15 years, Eastern Europe has Oncology Psychiatryenjoyed significant benefits as a result of the Cardiovascular diseases Neurological diseasesinvestment made by the clinical research Infection diseases (including vaccine trials) Bioequivalenceindustry. In addition to economic growth, life Allergology and immunology Endocrinology Urology Dermatologysaving therapies and medicine have been Gastroenterology Gynaecologyintroduced, providing stronger medical care Rheumology Haematologyfor its population. Pharmaceutical companies Pulmonology Anesthesiologyhave set up both marketing and research Orthopaedics Ophthalmology Surgery Otheroffices to take advantage of strong economicdevelopment, as well as the research benefitsof an informed and educated patient. In order to fully evaluate amendments added 2nd January 2000 and 30th Decemberand appreciate the current growth in the research environment, 2001), research has grown steadily (4). Based on informationit is easier to first examine one of the fastest growing countries. provided by the Federal Supervisory Agency for Health CareThe following, current information is from the largest and most and Social Development, in 2005 there were 447 approvedpopulated country in this region: Russia. trials involving 36,883 patients. In the first six months of 2006, the Ministry of Health has approved 228 trials that willCLINICAL RESEARCH IN RUSSIA TODAY enroll 23,059 patients. Based on the growth seen just within the first six months of the year, it is anticipated that, for theRussia is a country of 142 million people spreading across 11 current year, there will be more than 460 trials approved intime zones on two continents. The size of Russia may appear Russia, recruiting almost 50,000 patents. Of those alreadyimposing to the clinical research observer; however, the approved – 228 clinical trials so far – 148 of them aremajority of the population lives in or around major cities with multinational trials involving multiple sites for internationallarge medical institutions and experienced investigators. These corporations (5).cities are easily accessible via air, rail or highway, and typicallyprovide medical care to populations greater than one million. On a further breakdown of the information presented for theThe two major cities currently involved in clinical research are trials approved during the first six months, the therapeuticMoscow and St Petersburg. These two cities alone represent a areas with the most activity is oncology followed closelypopulation approaching 20 million and have specialised and by cardiovascular medicine and infectious disease. In ageneral hospitals offering research opportunities across the further breakdown of the oncology segment: nine trials werespectrum of therapeutic indications. for breast cancer, eight for haematology, seven for lung cancer, three for gastric cancer, three for prostate cancer, three forSince 1998, when Russia instituted Federal Law ‘On colorectal tumors, two for kidney cancer and seven for otherMedicinal Products’ 86-FZ, 22nd June 1998 (with oncology indications.www.samedanltd.com ICT 37
  3. 3. Current growth in Russia is driven by many of the same factors best work within the current system in order to smoothly handlethat push clinical research in other Eastern European countries. shipments of both study drug and laboratory specimens. HavingThe history of successful trial completion with high data quality a strong vested interest in the sponsors’ success ensureshas established strong sponsor confidence. There are many continued growth for their respective organisations anddrivers that have helped to build confidence in this region; the increases interest in their country across the industry.following represent a selection of those that have played a part. CONCLUSIONSite Experience and CommitmentEvery site involved in clinical research has to be included on an Eastern Europe may be the second highest patient recruitingapproved list of sites, and submitted to the MoH with the region of the world in industry-sponsored clinical trials, butapplication to perform the trial, ensuring that only experienced there is still tremendous room for growth and investment. Thisinvestigators can participate. In order to be included on the list, region offers a patient population equal to that of the US, yetthe investigator must have two years’ clinical trials experience currently those with the opportunity to participate in studies isand have received training in Good Clinical Practices. In far smaller. As a potential market for new medicines, theaddition, many of the sites are located in large medical opportunity will only increase as each of these nationsinstitutions in cities with good public transportation, allowing continues to strengthen their economy and develop anfor excellent patient access. Many of these sites, being located increasing interest in new medicines and treatments. Russiain large medical institutions, have databases of patients with alone has a population of 142 million, yet at present less thandiffering pathology that can be used to accelerate enrolment 100,000 patients participate in research over the course of aduring trial initiation and throughout the trial. In addition to year. Eastern Europe represents an unprecedented opportunitytheir experience and access to patients, investigators in Eastern for pharmaceutical and biotech organisations developing newEurope are experienced in working within the bureaucracy of medicines. The infrastructure is sound, the quality is proven andstate run healthcare, making them familiar with the large the potential is only now beginning to be fully realised. Namounts of documentation and accustomed to processingpaperwork accurately and completely. The author can be contacted at richard.leach@cro-rct.ruMotivated and Knowledgeable Patient Population ReferencesAs discussed already, the patient population in Eastern Europeis educated and knowledgeable about clinical research. As a 1. Tassignon JP, BioEthics in Eastern Europe, GOR, Vol 7,result of the current limitations of a state sponsored medical No 1, pp65-68, Spring 2005system in transition, patients are motivated to participate inclinical research. They see clinical trials as an opportunity to 2. Borfitz D, Expanding Opportunities in Centralreceive the highest level of medical care, while having access and Eastern Europe, CenterWatch Monthly, Volume 11,to new treatments that previously were unavailable to them. Issue 4, p5, April 2004Due to protocol requirements, they often have more time withtheir doctor than usual, and the diagnostic testing required to 3. Platonov P, Clinical Trials in Russia and Easternqualify patients frequently exceeds the standard practice of Europe: Recruitment Quality, International Journal ofthe region. As a result, the Eastern European patient tends to Clinical Pharmacology and Therapeutics, Vol 4, No7,be more compliant and less prone to leave a trial prior to pp277-280, 2003study completion. 4. Russia first adopted laws for governing clinical research inExperienced and Dedicated Service Providers 1998 with the Federal Law, ‘On Medicinal Products’, 86-FZThe atmosphere in Russia, as in Eastern Europe, is right for dated 22nd June 1998 (with the last amendment datedclinical research, due to experienced and committed sites, and 29th December 2004). In 1999 they incorporated ICH GCPmotivated, educated and knowledgeable patients. However there guidelines into industrial standard with the passing of OSTis another factor to consider when working in this region that 42-511-99 Rules of Clinical Trials Conduct in Russiancompletes this picture: the service providers – regional CROs – Federation and further defined the law in 2003 with theworking throughout Eastern Europe are proud of their role in Decree of the Ministry of Health of RF #266 dated 19thresearch and committed to the satisfaction of their customers. June 2003, titled About Approving of Clinical PracticeThese service providers understand the importance of success to Rules in Russian Federation. Now the National Standardtheir organisation and the country in which they work. They of Russian Federation GOST R 52379-2005 ‘Good Clinicalprovide highly educated CRAs, often MDs, to interact with the Practice’ is in force. This standard is completely identicalsites providing strong monitoring support. These CROs are to ICH GCP.experienced in working with the numerous regulatory groups,and frequently have personal relationships that help to facilitate 5. The Federal Supervisory Agency for Health Care and Socialapproval and maintain a high level of communications. Local Development site address is http://www.roszdravnadzor.ru/providers support import and export activities, and know how to medcontrol/clinic/ind?year=200638 ICT www.samedanltd.com
  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