CRO in Russia: Personnel, Regulations, Population, Sites, and Prospects for Clinical Research

Part II

Quality and Quantity of Research Personnel in Russia

Read Part I

There are about 4000 specialists employed by CROs in Russia. This number consists of an estimated 90% of specialists with MDs, a solid number of those with PhDs (or an equivalent postgraduate degree) – many of them having research experience. There are also a solid number of world-class project managers capable of supervising multicenter clinical study projects being conducted in different parts of the world.  These professionals – holding years-long experience in medical research and clinical studiescan conduct clinical trial steps from A to Z, being competent in both Gantt chart preparation and study design as well writing in several languages.

Contract research organizations prefer hiring personnel with no lower than solid upper-intermediate level English. Candidates with no clinical research experience take a compulsory basic GCP training course that can be provided either by the hiring company or by an independent organization providing external training. The number of the latter is steadily growing with their services’ success and popularity. Thus, fresh CRAs can opt for a basic one-day seminar or a five-day full-prep DRA program. However, training and development of personnel don’t end there. The newly hired specialists continue to be trained – this time, on the company’s standard operating policies and procedures. Along with GCP and CRA training, many CROs offer English language courses as well.

According to local state statistics, 8000 out of the total number of 690,000 physicians in Russia are involved in clinical trials, most of them being GCP-trained and fluent in reading and writing in English on professional issues. Along with money, these specialists are also strongly motivated by scientific interest, which results in a more reliable outcome.

Amicable Regulatory Environment

Today CROs can enjoy rather straightforward and transparent process of clinical trial application. RZN (RosZdravNadzor – a federal regulatory and surveillance agency) requires the following documents to be submitted:

  • an application letter
  • a final report on the preclinical study
  • approval from the NEC (National Ethics Committee)
  • a drug information leaflet.

These documents should be submitted in Russian, however, in the case of ambiguity, experts can refer to the original language of certain documents.  

Approval process at the NEC is mandatory for any clinical trial conducted in Russia. The Committee studies and evaluates the form of informed consent, the protocol, and the investigator’s brochure, along with checking meticulously information on dosage, drug safety, and possible adverse reactions – with the aim to ensure that the given clinical trial is scientifically sound, safe, and potentially beneficial for patients.

Meetings of the Committee of 36 members are held twice a month, and the approval process takes about 4 to 8 weeks.

Sites (To be) Involved in Medical Research

According to RZN report, only 792 Russian sites – out of about 9500 hospitals with a total capacity of 1.6 million hospital beds – were involved in clinical trials in 2007. It means that there is a huge untapped potential of about 92%. And this is to say nothing about the nearly 22,800 outpatient clinics with a total screening capacity of 3.6 patients a day. However, the number of sites involved in clinical studies is growing with about 60 every year, the majority of them being located in regions and not in Moscow or St. Petersburg.

Sites are equipped with everything necessary for conducting medical research on an international level, including special storage conditions, proper equipment (in many cases, a cutting-edge one), and high-speed internet. In many sites patient databases are classified by different diseases, to coordinate recruitment and ensure its high rate.

Other factors contributing to speedy recruitment (faster than in the US and Western Europe) are professional ties (or networking) among researchers and their knowledge of their patients’ results.

Monitoring Specifics

Participating in medical research in 2006 were 42,000 of Russia’s total population that in 2007 counted 142.2 million. The greater part of this population – about 73% – resides in metropolitan areas, and only 27% – in rural. The largest medical centers and regional hospitals in Russian are also located in major cities (matching the high concentration of population). Such distribution of population and health care facilities allows for a number of advantages when conducting clinical trials:

  • Patient recruitment becomes easier and faster.
  • Transportation and overhead costs decrease.
  • Monitoring expenses decrease, as a monitor can visit more than one center a day.

It is worth mentioning that in Russia there are a considerable number of treatment-naïve patients in various types of infectious diseases as well as in HIV and oncology.

Another significant aspect when considering Russia as the destination for conducting long-term medical research is the low migration rate in this country, which means there will be an insignificant number of dropouts due to migration among patients involved in clinical trials.

Bottom line

Those companies – sponsors, pharma and international contract research organizations – that will choose to conduct medical research on Russian CRO market will be able to enjoy the following advantages:

  • the largest population among countries of Central and Eastern Europe, with an over 90% of untapped potential for clinical trials
  • research costs  lower than on established markets
  • qualified, experienced, GCP-trained investigators providing quality data
  • a vast number of treatment-naïve patients
  • over 55 Russian CROs competing for contracts.