The EU Clinical Trials Directive will increase the need for and the interest in doing clinical work in Eastern Europe, and specifically in the Russian Federation. More than 750 international multi-center clinical studies were conducted in Russia through 2003, and more than 60% of the approved protocols were submitted by sponsors from the USA, Western Europe and Japan (including Pfizer, Sanofi, GlaxoSmithKline, Bristol-Myers Squibb, Bayer, Novo Nordisk, Johnson & Johnson, AstraZeneca, Hoffman-La Roche, and others).

Common reasons that influence a Sponsor’s decision to initiate a clinical trial in Russia include:

1. Expedited start-to-completion study time facilitated by:
   - a short regulatory approval process (3 months);
   - high rates of patient enrollment (guaranteed by a large number of very motivated sites with high subject to site ratios).
2. Cost-effective clinical research solutions.
3. Established centralized medical infrastructure allowing access to patients treated at specialized medical facilities (oncology, TB, cardiovascular, HIV, etc.).
4. Access to large, diverse patient pools available for enrollment (including large percentage of treatment-naïve subjects).
5. All CRAs are registered MDs trained in GCP guidelines .
6. Low internal migration allowing for extended follow-ups.

Site productivity in Russia can be up to ten times more effective than in other regions (USA, Western Europe, Asia) therefore conducting a clinical trial in Russia can significantly shorten the time to market for your drug candidate. A shorter clinical study time means a shorter time for reaching “Go/No Go” decisions and therefore an increase in research investment return through faster revenue generation and a longer time before patent expiration. In the case of a blockbuster drug, this can be significant since even a small decrease in time has a large dollar impact. For example, a drug generating $500M sales per year produces approximately $41M a month, therefore each week of delay could cost a drug discovery and development company $9M in lost revenues.

How to start a clinical trial in Russia?

Regulatory and ethics approval must be obtained to begin a clinical study in Russia, a process that usually takes about 3 months. First, regulatory approval is obtained from the Ministry of Health. Following that, National Ethics Committee (NEC) approval is sufficient to initiate the study, however if an individual site insists on local EC review, it also has to be obtained. Submission of clinical protocol to both authorities can be done at the same time.

What documents will you need to begin a study in the Russian Federation?

Once the regulatory submission is approved, CCCP will submit an application for an import permit for the study supplies, such as investigational drug, concomitant medicines, etc. Target completion time: 1 month.