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Clinical trials in the Russian Federation

Russia. Country Overview

Russia or the Russian Federation can offer many advantages to pharmaceutical companies as a location for clinical trials. Russia, officially the Russian Federation, is one of the largest countries in Europe. Is the ninth largest country in the world. Russia is the largest country in terms of area.

Russia has a population of 143 million people. The population of Russia is very diverse. Russia is a multinational state, home to over 193 ethnic groups nationwide. In the 2021 census, about 81% of the population were ethnic Russians, 19% of the population were ethnic minorities. Russia is also home to many immigrants, especially from Central Asia and the Caucasus region. Russia's large and diverse population is good for clinical trials because it provides access to a large number of patients representing diverse populations.

Russia has a centralized healthcare system, with the government playing a major role in the provision of healthcare services. The country's healthcare system is funded through a combination of public and private sources, with most of the funding coming from the government.

Under the Russian healthcare system, all citizens are entitled to free basic healthcare services, including primary care, preventive services, and emergency care.

The healthcare system in Russia is a mix of public and private healthcare services and is well developed in major cities. The healthcare system in Russia is administered by the Ministry of Health and includes a network of hospitals, clinics, and other healthcare facilities throughout the country.

Russian citizens and legal residents are entitled to free or low-cost medical care in public hospitals. The public healthcare system is funded by a combination of taxes, social security contributions and out-of-pocket payments. Private health care in Russia is financed through out-of-pocket payments, health insurance, and employer-provided health benefits. The healthcare system in Russia has undergone significant changes, with an emphasis on improving access to medical care and modernizing medical facilities. Large cities have large modern hospitals with new equipment and extensive diagnostic facilities. Patients in large cities have good access to modern medicines. On the other hand, access to healthcare in some parts of the country, especially in rural areas and some cities, can be limited, and patients may be eager to participate in clinical trials and drug naïve patients can be identified.

Russia has a relatively high hospital bed density compared to other countries.

A relationship of trust between doctors and patients contribute to the rapid recruitment in clinical research, as well as retention of patients in a clinical trial.

Russia has a well-established infrastructure for conducting clinical trials. The country has a large pool of highly qualified medical professionals and researchers, as well as a network of hospitals, clinics, laboratories, diagnostic centers, and research centers equipped with modern medical technologies and equipment. According to the latest available data from the World Health Organization (WHO), in 2019 there will be approximately 1.3 million hospital beds in Russia. This corresponds to a hospital bed density of about 8.9 beds per 1,000 inhabitants. According to the latest available data from the World Health Organization (WHO), there will be approximately 443,000 physicians in Russia in 2020. This corresponds to a physician density of about 3.0 physicians per 1,000 inhabitants. According to the latest available data from the Federal State Statistics Service of the Russian Federation, there will be approximately 8,300 hospitals and medical centers in Russia by 2021.

The literacy rate in Russia is very high, almost 100% of the population can read and write. According to the latest available data from the World Bank, the literacy rate in Russia in 2019 was 99.7%. There is no lack of understanding of clinical trial informed consent documents by patients in Russia.

According to the latest available data from the United Nations, in 2020 about 74% of Russia's population lived in urban areas. The country's largest cities, such as Moscow and St. Petersburg, are major economic and cultural centers and are home to much of the country's population. In addition to these larger cities, there are many medium-sized and smaller cities throughout the country, many of which have experienced significant growth and development in recent years. The largest cities in Russia are Moscow, St. Petersburg, Novosibirsk, Ekaterinburg, Nizhny Novgorod, Kazan, Chelyabinsk, Omsk, Samara, and Rostov-on-Don.

High urbanization brings some advantages for conducting clinical trials, there is no need to open many clinical research sites, sites can be opened in major cities.

The leading causes of death in Russia include cardiovascular disease, cancer, and external causes such as accidents and injuries. Other major causes of death in Russia include respiratory diseases, liver diseases, and infectious and parasitic diseases. Russia can be a great place for clinical trials in the above mentioned areas. High prevalence of chronic diseases and cancer, which also increases the speed of recruitment and the insertion in clinical studies patients without prior treatment and with different degrees of severity of the process.

The pharmaceutical market in Russia is one of the largest in the world, with a total value of approximately $23 billion in 2020. International companies set high standards for clinical trials data, which Russian companies also need to follow when conducting clinical trials.

The cost of living in Russia can vary significantly depending on the region, with prices generally higher in major cities such as Moscow and St. Petersburg. Overall, the cost of living in Russia is generally lower than in many other developed countries. This translates into significant savings for clinical trial sponsors in terms of CRO costs and PI/site payments. Placing clinical trials in Russia might bring a lot of economic advantages.

The Clinical Trials Landscape in Russia

In 2022, 34 new drugs will be registered by the FDA. 9 of these FDA-registered novel drugs were tested in clinical trials in Russia.

According to the FDA 2015-2019 Drug Trials Snapshots Summary Report, Russia accounted for 4% of the participants enrolled in clinical trials globally.

This shows how important the Russian clinical trials market is for global drug development.

According to the Russian Clinical Trials Registry, there are about 1000 ongoing clinical trials in Russia. The registry contains information on 9520 clinical trials. 40% of all ongoing clinical trials are initiated by foreign companies, while Russian sponsors account for 60% of all clinical trial applications. The most common therapeutic areas in Russia are oncology, cardiology, endocrinology, infectious diseases.

Russia was included into a lot of studies with slow enrollment to catch up with timelines and patient enrollment.

Quality of Clinical Trials in Russia

FDA and EMA inspections have demonstrated the high quality of clinical trial data in Russia.

There have been 63 FDA inspections in Russia. The results were positive: 50 NAIs1 and 13 VAIs2.

No Action Indicated, i.e. no objectionable conditions or practices were found during the inspection (or the significance of the documented objectionable conditions found does not warrant further action).

Voluntary Action Indicated (VAI), which means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action; or Official Action Indicated (OAI), which means that regulatory and/or administrative action will be recommended.

Smooth Drug Development also has experience with EMA inspections of Russian sites in its trials. The inspection did not result in any findings at the sites which proves the high quality of data in Russia.

The Russian Roszdravnadzor also inspects sites in Russia on ongoing basis. The schedule of such inspections is published on its official website.

Regulatory Environment in Russia

Regulatory requirements for clinical trials in Russia are governed by the Federal Law "On Circulation of Medicines" and the Rules for Conducting Clinical Trials of Medicines, which were updated in 2019.

The application for clinical trial is submitted to the Ministry of Health of the Russian Federation, which forwards the documents to the Federal State Budgetary Institution for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation and the Ethics Council of the Ministry of Health of the Russian Federation. The documents are considered for 40 working days. All documents in the submission package must be translated into the Russian language. The documents to be submitted include Protocol, IB, ICF, PoA, GMP Certificate, Manufacturing License, CoA. IMPD is not required for submission. There is no QP release process in Russia.

To ship the drug to Russia, it is necessary to obtain an import license. An export license is required to export biological samples.

As Russia is a member of the EAEU, it must follow the EAEU guidelines for clinical trials. Clinical trials for EAEU registration are conducted in accordance with EAEU requirements. It is also important to note that registration of drugs in the EAEU may require patients to be enrolled in one of the member countries of the Union. Other countries in the EAEU include Belarus, Armenia, Kazakhstan and Kyrgyzstan.

Summary. Clinical Trials in Russia

Russia has a large patient population, which makes it an attractive location for conducting clinical trials. Clinical trials in Russia have many additional advantages:

  • Proven patient enrollment;
  • Cost efficiency;
  • Transparent regulatory environment;
  • Well-developed infrastructure for conducting clinical trials;
  • No need to go through QP approval;
  • No need to submit IMPD to MoH;
  • Access to large number of patients;
  • Access to drug-naïve patients;
  • ICH GCP is a national standard.

Smooth drug development - a CRO in Russia.

As a trusted CRO partner, Smooth Drug Development has full-service capabilities in Russia and other high recruiting countries in Europe, CIS, EAEU and India. We provide high quality clinical trials to local and international biotech, pharma and CRO companies. Smooth Drug Development conducts local and global trials.