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The Regional Alternative

Even though the total number of patients enrolled for clinical trials in the US is still far greater than in any other country, there is an evident shift in patient recruitment away from ‘core’ Western countries to the so-called emerging clinical trial markets. According to the recent survey conducted by CMR International, the Russian Federation is now among the five highest recruiting countries, with each of these enrolling substantially more patients than some of the well-established European clinical study countries such as France and the UK (1). Based on data provided by a consistent cohort of 18 companies, the number of patients enrolled in Russia has increased considerably in recent years, propelling it into the top five. The number of patients has more than doubled in Russia, based on a comparison of 2002-2004 to 2005-2007 data, and the number of clinical trials has nearly tripled over the last decade.

However, as the number of studies increases, the number of concurrent trials conducted at a single investigational site grows even faster. Unfortunately, the number of investigators does not match this growth; as a result, the high number of parallel studies conducted at a single site in the same indication negatively affects enrolment. According to the CMR survey, Russia, along with some other ‘emerging’ countries, has shown a considerable decline of 19 per cent in median normalised enrolment rates over the last five years. This may be indicative of saturation effects in highly developed countries, but in any case, is a clear sign that the ‘traditional’ approach to patient recruitment in Russia does not work, and that the best worldwide enrolment methods should be customised and implemented, taking into account the local specifics.

LOCAL EXPERIENCE AND SUCCESSFUL RECRUITMENT

Most of the factors affecting patient recruitment are wellrecognised, but getting to grips with these key factors can have a positive effect and lead to an increase in recruitment rate. Profound insight on general appropriateness and local peculiarities of trials allows the definition of several groups of problems: professional, managerial-logistics, patient and trial-specific, regional and country-specific.


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Oleg Tikhonov is a Clinical Research Associate at Synergy Research Group. He graduated from Russian State Medical University. At present, his scientific interests are neurology and neuropsychiatric science and he is now a senior teacher at the Moscow Humanitarian University (Neurology and Psychopathology). He has authored more than 10 scientific publications. He started and continued his clinical trial career in Synergy Research Group. Oleg is experienced in conducting clinical research into HIV, psychiatry, urology and pulmonology. He has implemented nonstandard methods of subject enrolment intensifying and has participated in patient recruitment service development.

Natalia Ukolova graduated from the Moscow State University with an MA in Chemistry in 2007. Her experience with clinical research started at Synergy Research Group, where she has been involved in the endocrinology, neurology, AIDS/HIV-related and cardiology studies. She has also worked as an assistant to the auditor of a neurology project and participated in helping to prepare the centres for FDA inspections. In everyday work, she especially likes cases and projects that require an extraordinary approach and synchronised team work. Natalia is a Clinical Research Associate at Synergy Research Group.

Platon Komissarov, Project Manager at Synergy Research Group, is a graduate from Moscow State Medical University. He studied as a postgraduate student in the Department of Psychiatry. He holds a PhD in Medicine (Neuropsychiatry). During his postgraduate studies, he participated as an investigator and study coordinator in many clinical trials. He is experienced in the management of clinical trials in different therapeutic areas, particularly in psychiatry, AIDS and oncology. He is accustomed to finding and implementing new approaches in patient recruitment basing on proven strategies and cumulative experience.

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Oleg Tikhonov
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Natalia Ukolova
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Platon Komissarov
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