CLINICAL RESEARCH |
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Innovative early phase clinical research activities in Eastern Europe
Dr Karl M. Eckl and Dr Franz Janik, InnopharR
In the last 10 years, many pharmaceutical companies and CRO s moved into Eastern Europe in order to find new and efficient resources for patient recruitment. InnoPhaR GmbH, a German CRO was one of them. However, unlike the other companies who conducted Phase III clinical studys in public hospitals, InnoPhaR developed a niche way of performing clinical studys and recruiting patients. This article describes InnoPhaR’s strategy for conducting early phase clinical studies.
InnoPhaR GmbH
 POLYCLINIC NO3 IN CHERNIVTSI |
InnoPhaR focuses on clinical studies mainly in Phase I and Phase IIa. They combine fast recruitment of patients with a high quality of clinical data. Apart from Russia, where several well organised Phase I units exist, Phase I and Phase IIa studies in Eastern Europe is still rarely conducted – most CRO s and pharma companies concentrate on Phase III studies. InnoPhaR GmbH was one of the first CRO s that realised the potential advantages of developing resources for early stage clinical research in the target population in countries like Ukraine and Moldova. InnoPhaR’s recruitment of patients is conducted in a multi-centre way, but clinical studies are conducted in a mono-centre way by using its own clinical facilities which are exclusively used for clinical research but always involve the same well trained and experienced clinical team.
Location of InnoPhaR’s Clinical Sites
InnoPhaR currently has two clinical sites, one located in the south west of Ukraine at Boyan, close to Chernivitsi, the capital of the Bucovinian district. The other clinical site is located at the National Institute of Cardiology in Chisinau, the capital of Moldova. Both Chernivtsi and Chisinau have well established Medical Universities and usually provide experts from major therapeutic areas as sub-investigators or investigators if necessary. They are easily assessible with daily flights in and out of the cities.
Most of the CRO s working on an international level are located in Kiev or the large industrial regions in the east of Ukraine. The advantage of InnoPhaR being based in a location close to Chernivtsi and far from Kiev, is that there is no competition with other CRO s for patient recruitment. On the other hand, the advantage of InnoPhaR’s location in Chisinau with a current population of around 7.5 million inhabitants, is that all the major hospitals are centralised in the capital.
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InnoPhaR for special population studies
InnoPhaR’s early phase studies are cost-effective because fast recruitment of patients saves time without compromising the high standards of quality. InnoPhaR’s competitive edge is in performing Phase I studies in special patient populations which have been problematic for many CRO s, including large global ones. Additionally, InnoPhaR has focused on proof of concept studies in the target population. It also contributes, as a single site, to Phase III multicentre studies.
InnoPhaR’s competitive edge
- Niche method of patient recruitment;
- High quality of performing clinical studies (standardised condition and own quality control systems);
- Highly motivated and experienced staff.
InnoPhaR’s Recruitment Strategy
It appears that there are limits to the classical way of performing early phase clinical studies in patients in public hospitals. In particular, it seems that Phase I and IIa studies are best performed in clinical sites under strict controlled conditions. The major disadvantage of conducting these studies in general hospitals is a lack of quality in study performance, often due to the constant change in clinical teams and lack of controlled conditions.
 INNOPHAR’S CLINICAL SITE IN BOYAN, UKRAINE POLYCLINIC NO3 IN CHERNIVTSI |
InnoPhaR’s new philosophy is supported by the centralised health system in Ukraine and Moldova. Patients always join the same polyclinic to see their family physician first. These polyclinics have information on diagnosis, therapy and concomitant disease of thousands of patients in their data bases. In compliance with local law family physicians of different polyclinics recruit patients for clinical studies on a contractual basis for InnoPhaR’s clinical sites according to the inclusion and exclusion criteria of study protocols. All other procedures are performed under strict controlled conditions in the clinical sites of InnoPhaR always by the same well trained clinical team, in a clinical area which is not involved in any other therapeutic or diagnostic activities.
The clinical team can thus concentrate on the performance of the clinical study only. These procedures guarantee fast recruitment and high quality level of clinical data. As an example, in Polyclinic No 3 in Chernivtsi, headed by Dr Pavel D. Kotsovan (an expert in internal medicine), 56 specialists are working in therapeutic areas like internal medicine, dermatology, gynaecology, rheumatology, cardiology, endocrinology, nephrology, surgery, gastro-enterology, ophthalmology and urology. Polyclinic No 3 covers a population of 32,000 inhabitants.
InnoPhaR’s Quality Control System
In addition to standard operating procedures (SOPs) which are available in Russian and English languages, both InnoPhaR clinical sites have their own quality control system. Independent quality control managers not involved in any study related tasks supervise adherence to study protocol, SOPs, international guidelines and local legal requirements, from screening to archiving of documents.
A highly motivated and experienced staff – InnoPhaR’s major asset
| Prof. Semen Biletzki, Clinic Director at InnoPhaR’s site at Boyan, Ukraine, is one of the leading internal specialists and cardiologists in the Chernivtsi area. He has five years experience as an investigator in Phases I to III clinical studies. |  |
| Svetlana Polonyuk, Site Manager at Boyan was basically trained in medical administration. She has been responsible for all organisational aspects at the site since 2002. |  |
| Dr Karl M. Eckl, physician and physicist, is Director of the site in Boyan. He has experience as sub/investigator in more than 350 clinical studies. He is responsible for all quality related aspects. |  |
| Dr Nahum Tsvitaum, an experienced anaesthetist, is Director and head of the clinical team of the InnoPhaR site in Chisinau. He was trained as an investigator from 1997 to 2002 in a German CRO . He has 10 years experience as an investigator for Phase I to III clinical studies. |  |
| Natalia Cornea, Site Manager at Chisnau, trained as nephrologist has 2.5 years experience in site management. |  |
| Arcadie Astrahan, physician, is Project Manager and Recruitment Manager at Chisinau with two years experience in practical clinical research in Phases I to III. |  |
Besides the senior managers there are six quality control managers, two pharmacists and 58 clinical team members like physicians (most of them anaesthetists and experienced in emergency treatment) and nurses. In addition, the clinical team consists of two groups of medical experts from the local medical university covering all major therapeutic areas who join the team as co-investigators depending on the type or patients recruited for the study.
Dr Karl M. Eckl & Dr Franz Janik
Dr. Karl M. Eckl is Executive and Medical Director of InnoPhaR and Executive Director of InnoPhaR’s clinical site in Ukraine. Since 1985 he was responsible as sub-investigator or investigator in more than 350 clinical studies in phase I to III.
Dr. Franz Janik is Executive Director and Director Business Development of InnoPhaR. Trained as biologist and pharmacologist he has gained experience in pharmaceutical medicine and clinical research since 1987.
Examples of studies conducted at InnoPhaR
- Studies on cardiac safety (including QTc prolongation in postinfarction patients vs healthy subjects;
- Efficacy in breakthrough pain in end stage cancer patients;
- First administration bio-engineered products in patients with kidney disease;
- Efficacy and safety in patients with instable bladder syndrome including urodynamics;
- Pharmacokinetics in patients with renal disease (mild, moderate, severe);
- Pharmacokinetics in patients with hepatic disease (Child Pugh A,B ,C).
InnoPhaR GmbH
Dr. Karl M. Eckl
Tel.: +49 (0)9964 6010216
Fax: +49(0) 9964 6010217
e-mail: eckl@ipr-ee.com
web page: www.ipr-ee.com
