In 2018 health authorities (HAs) approved 653 clinical trials (CT) in the Russian Federation, less in overall numbers compared to the same indicator from 2016 – 898 approved CTs. However, this decrease was observed across all types of clinical trials except for international multicentre clinical trials (IMCT), which opposed the trend, increasing by 2.1% from 281 to 287.
[ngg src=”galleries” ids=”15″ display=”basic_thumbnail” override_thumbnail_settings=”1″ thumbnail_width=”950″ thumbnail_height=”950″ thumbnail_crop=”0″]The share of IMCTs reached 44% of the overall number of clinical trial approvals issued, the highest figure since 2012.
Advantages of conducting the clinical trial in Russia
Below, you will find the main advantages of running a clinical trial in Russia:
- Short enrollment periods supported by the centralized healthcare system and available patient pool and high recruitment rate;
- A good selection of highly qualified research centres. 1445 medical organizations are accredited to conduct clinical trials today;
- Data acceptance (Russian trial centres have successfully passed through many audits, and inspections including FDA and EMA and modern technologies are available at the majority of hospitals);
- Relevant investigators expertise (educated, experienced and compliant investigators and staff who are GCP trained and certified);
- Cost-efficiency (lower investigator grants and ancillary costs);
- Growing clinical trial infrastructure, including early-phase trial sites;
- Improving regulatory framework.
Clinical trial approval process in Russia
Main regulatory bodies in Russia for clinical trial processes are as follows:
- Ministry of Health of the Russian Federation (MoH): Accreditation of medical Institutions, Approval of clinical trials, Information services related to clinical trials and Relations with the medical community.
- Federal Service for Surveillance in Healthcare: Supervision of clinical trials, Inspections in clinics and Pharmacovigilance.
- Scientific Center of Expertise of Medical Products (SCEMP): Review quality, efficacy and safety data of new drugs and scientific expertise of the proposed clinical studies and Ongoing review of updated/new clinical trial information/documents.
- National Ethics Committee (NEC): Review of clinical trial applications and provision of opinions on ethical aspects of clinical trials.
The regulatory process for obtaining clinical trial authorization illustrated below:
[ngg src=”galleries” ids=”16″ display=”basic_thumbnail” override_thumbnail_settings=”1″ thumbnail_width=”950″ thumbnail_height=”950″ thumbnail_crop=”0″]The regulatory process itself is transparent and starts with the submission of the application to the Ministry of Health (MoH). Once the application is received, within 5 working days the MoH shall review the completeness of submission and, if the application is not found to be deficient, shall forward it to the National Ethics Committee (NEC) and the Scientific Centre for Expert Evaluation of Medicinal Products (SCEMP) for review or, return it if the application as incomplete or otherwise deficient. The MoH conducts scientific and ethical expertise of the provided documents, performed in parallel by the Scientific Centre for Expert Evaluation of Medicinal Products and Ethics Committee respectively.
“In Russia, clinical trial sponsors will be dealing with competent and motivated English-speaking investigators.”
At the NEC, members of the committee receive copies of the application package. Later the NEC reviews the application during their routine committee sessions, typically these sessions are held once a month, where a simple majority of members present at the NEC session makes the decisions.
Timeframes of clinical trial approvals in Russia shown in the table below:
[ngg src=”galleries” ids=”17″ display=”basic_thumbnail” override_thumbnail_settings=”1″ thumbnail_width=”950″ thumbnail_height=”950″ thumbnail_crop=”0″]
Import and export requirements
After the MoH study approval obtained, the study team can apply for an import license for the Investigational Product and export license for biological samples.
[ngg src=”galleries” ids=”18″ display=”basic_thumbnail” override_thumbnail_settings=”1″ thumbnail_width=”950″ thumbnail_height=”950″ thumbnail_crop=”0″]The licenses applications require separate document packages and expected to be completed by the authorized vendor. MoH official review timelines are 12/19 calendar days (for import/export).
Local ethics committee involvement
Local Ethics Committees (LECs) approval is the final step in the study approval process before starting patient enrollment. LECs are present in all major investigative sites and usually meet every month. Ordinarily, this process, together with import/export license applications, is performed in parallel in order to save time.
“Investigators are educated, experienced and compliant together with staff who are GCP trained and certified.”
Contracting process description
In Russia, the contracting process is well defined, and the causes of delayed study start arise only in very rare cases. Note that, before the study initiation visits, all contracts have to be signed. The law has defined three main types of contracts:
- Between the Sponsor (or CRO) and the hospital site;
- Between the sponsor (or CRO) and responsible investigator;
- The tripartite contract between the sponsor (or CRO), the scientific/educational establishment (university or institute), and the hospital site.
Individual contracts are a great benefit. Usually, State hospitals/universities do not have international currency accounts and are paid only in national currency.
Conducting clinical trial in Russia may be considered as a good option for the international pharma and biotech companies when they need fast subject enrollment, especially in case of a rare disease or treatment-naïve patient population. In Russia, clinical trial sponsors will be dealing with competent and motivated English-speaking investigators, who produce high-quality trial data. As well, in the Russian Federation, overall project costs are considerably competitive comparing to the other countries.
If you want to get more specified information, adjusted to your project and specific needs, contact us!
Oleg Kungurtsev, MD
Manager Clinical Operations