There are two resources most often used to search for clinical trials conducted in Russia. The first is the official register of the Russian Ministry of Health www.grls.rosminzdrav.ru. Its advantage is that it is in Russian and contains a list of medical centers in Russia where the study is being conducted. The second is www.clinicaltrials.gov - the international registry of clinical trials of the US National Institutes of Health. This resource is useful with more detailed and important information about the studies such as inclusion criteria, but is maintained in English. Therefore, when searching for a clinical trial, we recommend using two resources in parallel.

§1. Search for a clinical trial on the website www.grls.rosminzrav.ru

Below is a description of how to search for a study based on specific criteria.

Step 1. Go to http://www.clinicaltrials.gov/ and select the “Advanced search” section

1. Recruitment – ​​select Open studies (studies that are currently recruiting patients or have not yet begun, as well as expanded access programs);
2. Study Type – select Interventional Studies;
3. Conditions – diagnosis in English;
4. Country 1 – Russian Federation (It should be noted that the Russian Federation is not always listed in the list of countries, so we also recommend that you search again without specifying the country);
5. Search – search.

Step 3. If the search produces results, you will see a list of studies that match the query parameters.

Step 4. You can find out more detailed information by clicking on the line with the study you are interested in.

Pay special attention to the following information:

1. Purpose – the purpose of the study;
2. Drug - name of the drug;
3. Eligibility – criteria for inclusion in a clinical trial.
4. Other Study ID Numbers – protocol numbers for identification in other registries, including for searching in the registry of the Ministry of Health of Russia.

Step 5. If you think you have found a suitable clinical trial, the next step is to check whether it is ongoing in Russia. To do this, go to the website www.grls.rosminzdrav.ru and try to find this study in the register of the Russian Ministry of Health - see §1.

The study can be found by the protocol number listed in the “Other Study ID Numbers” line. If there is more than one protocol number on this line, try searching one by one.

Clinical trials are carried out only after receiving special permission from the Ministry of Health of the Russian Federation (MHRF) to conduct a clinical trial. To obtain a permit, it is necessary to prepare a package of documents for a clinical trial in paper and electronic form, pay the state fee and submit an application for a permit to the Ministry of Health of the Russian Federation in the Department of State Regulation of Medicines Circulation (Moscow, Rakhmanovsky Lane, 3) and on the http portal ://grls.rosminzdrav.ru

The package of documents includes:

A copy of the document confirming payment of the state duty;

Clinical trial protocol;

Researcher's Brochure;

Patient Information Sheet;

Information about the work experience of researchers in relevant specialties and their experience in conducting clinical trials;

Information about medical organizations where the clinical trial is expected to be conducted;

Information on the expected timing of a clinical trial of a medicinal product for medical use;

A copy of the compulsory insurance agreement;

Information on the composition of the medicinal product for medical use;

A document drawn up by the manufacturer of a medicinal product for medical use and containing indicators (characteristics), as well as information about the medicinal product for medical use, produced for clinical trials;

A copy of the license for the production of medicinal products (if the drug is produced in the Russian Federation) or a copy of the conclusion on the compliance of the medicinal product manufacturer with the requirements of the Good Manufacturing Practice rules, issued by the competent authorized body of the country producing the medicinal product.

The Ministry of Health of the Russian Federation, within 5 working days from the date of acceptance of the application and necessary documents:

Checks the completeness and accuracy of the information contained in the submitted package of documents;

Decides to conduct an examination of documents to obtain permission to conduct a clinical trial and ethical examination or to refuse to conduct these examinations;

Notifies the applicant electronically or on paper about the decision made;

Prepares and sends to the Ethics Council and the expert institution (FSBI “SC ESMP” of the Ministry of Health of the Russian Federation) an assignment for conducting relevant examinations. The examination and drawing up by a commission of experts and the Ethics Council of opinions on the possibility or impossibility of conducting such a clinical trial and sending these conclusions to the Ministry of Health of the Russian Federation are carried out within a period not exceeding 30 working days from the date of receipt of the task.

All approved clinical trials are included in the Register of Approved Clinical Trials and are available on the portal http://grls.rosminzdrav.ru.

Roszdravnadzor (Federal Service for Surveillance in Healthcare http://www.roszdravnadzor.ru) supervises the conduct of clinical trials. According to the order of the Ministry of Health dated September 29, 2011, the Administrative Regulations of Roszdravnadzor were approved for the implementation of the state function of supervising the conduct of preclinical and clinical trials of medicines intended for medical use.

Roszdravnadzor carries out:

Current and emergency inspections of legal entities engaged in
organizing and directly conducting
clinical and preclinical studies;

Obtaining and analyzing data provided by departments
Roszdravnadzor, about clinical studies.

When conducting an inspection, authorized persons of Roszdravnadzor are obliged, among other things, to:

Do not prevent the manager or an authorized representative of a certain entity carrying out the organization of the study from being present during the inspection and providing explanations on issues regarding the subject of the inspection;

Based on the facts of detected violations, take measures proportional to the severity of the violations and their possible threat to the life and health of people;

Do not request from subjects organizing research documents the submission of which is not provided for by the legislation of the Russian Federation, as well as documents that can be obtained from other state control bodies.

Clinical research can only be conducted in a research center accredited by the Ministry of Health of the Russian Federation. There is a list of accredited centers, which is systematically supplemented and changed. The current list of accredited research centers, as well as orders of the Ministry of Health of the Russian Federation on the accreditation of medical organizations for the right to conduct clinical trials are available on the portal http://grls.rosminzdrav.ru

After completion of the clinical trial, the applicant submits a report with the results of the clinical trial to the Ministry of Health of the Russian Federation within a period not exceeding 3 months from the date of its completion.

More details can be found in the manual "Clinical Research Management".

The manual consists of eight Sections.

Dear Colleagues, based on the results of the round table, I would like to touch upon the topic of providing patients with wider access to information about ongoing clinical trials.

From my experience working in a clinic, a pharmaceutical company and in the Regulatory Authority of our country, not every potential patient who can participate in clinical trials is aware of the studies being conducted. It is almost always a surprise for our patients when their attending physician offers participation in a clinical trial (CT), while changing the previously conducted therapy for the disease to an experimental one.

Patients and other members of the public can greatly benefit from global clinical trials.

For some, participation in a CI can save lives. The WHO has announced rules requiring pharmaceutical companies and other companies (CROs) conducting research to disclose 20 sets of data when registering clinical trials they plan to begin.

In developed and developing countries, there are already Primary Clinical Research Registers that are properly formalized (based on the requirements of the WHO and the International Committee of Medical Journal Editors (ICMJE)):

Australian and New Zealand CI Registry

Brazilian CI Registry

China CI Registry

Indian CI Registry

Cuban State Clinical Trials Registry

EU Clinical Trials Register

German Clinical Trial Register

Iranian Clinical Trials Registry

Japan CI Registry

Netherlands CI Registry

Pan African Clinical Trials Registry

Sri Lanka CI Registry

All CI specialists know that all new drugs must be tested in human clinical trials, testing safety and effectiveness.

But those fatal cases that occur during international clinical trials could be avoided by allowing everyone to have access to the history of the trial of a particular drug. Previously, when patients were included in clinical trials, information about tragic cases of use of a new drug was not provided.

It is partly to prevent such violations of patients' rights that WHO formed the Global Network of Clinical Trial Registries (ICTRP).

Web search based on the ICTRP platform is available to the general public.

Trials registered in specific WHO Primary Registers can be searched in the following languages:

Chinese

Dutch

German

Japanese

Korean

Persian

Anyone can directly contact WHO staff for clarification or assistance when working with the CI Registry Platform at:

World Health Organization

[email protected]

The main goal of the network, known as the International Clinical Trial Registry Platform, is to increase transparency by requiring any company or institution conducting clinical trials of a drug to record data about how it will do so.

Companies or other institutions that organize clinical trials will be required to disclose 20 points that describe the clinical trial process in the form of standardized summaries. Not everyone is happy about this commitment.

There is great reluctance on the part of the pharmaceutical industry regarding full disclosure. The industry is well aware of the negative recent cases of companies withholding negative research results, which have caused public outrage.

Since September 2005, the International Committee of Medical Journal Editors (ICMJE) has refused to publish trial results that were not published in the CI Registry. Publishing research results in these journals is an important step toward obtaining FDA approval of new drugs.

WHO initiatives aim to unite the efforts of participating CI registries around the world into one global network. This will provide a single point of access to their stored information and a web-based search platform where members of the public can obtain basic information about ongoing and completed clinical trials, including trial contact details.

The goal is to increase transparency and accountability on the part of companies and institutions conducting clinical trials, and, in turn, increase public trust and confidence in the authority of the company producing new drugs.

There are a huge number of new areas of targeted therapy in preclinical and early clinical cancer trials. Patients with resistant forms of cancer often search for these trials online as their last and only chance.

Registries for ongoing clinical trials are often inaccurate and incomplete to date. For English-speaking patients, for example, there is a resource for cancer patients, EmergingMed.com, where you can put your profile in the system, and the search engine will strive to match your search for CIs now and in the future. It's very simple and very effective.

For example, a patient with leukemia who had begun to develop resistance to the drug Gleevec began searching the Clinicaltrials.gov clinician clinical trials database. It was there that he discovered that he was now undergoing a clinical trial for his disease in Canada.

He boarded a plane and when he arrived in Canada, he was told by one of the research assistants that an identical study was being conducted in his hometown, Rome. Italy does not have a CI Register. The man had no way of knowing what was happening on his doorstep.

20 points that will have to be presented when registering clinical trials in the Primary Registry:

Initial registration name and unique identification number

Date of registration in the primary CI Register:

Secondary ID: other identification numbers and release of information to authorities

Source of monetary or material support for CI

Primary Sponsor: the person, organization, group or other entity responsible for the trial

Secondary Sponsors:

Contacts for general inquiries

Contact for scientific inquiries:

Public title: intended for the lay public in accessible language.

Scientific name of this study as stated in the protocol

Patient Recruitment Countries

Nosology of diseases or conditions to be studied

Types of interventions

Basic inclusion and exclusion criteria for participants, including age and gender

Type of study

First participant recruitment date

Target sample size

Recruitment status (pending, currently recruiting, or closed)

Primary result

Main secondary outcomes

In Ukraine, the Primary Register of CIs has not yet been created in a language accessible to patients. We hope that in the near future the Regulatory Authorities of our country will pay attention to the need to inform the public about clinical trials conducted in Ukraine.

Sincerely, Evgeniy Zadorin, Ph.D.

Document title:
Document number:	751n
Document type:
Receiving authority:	Ministry of Health and Social Development of Russia
Status:	Active
Published:
Acceptance date:	August 26, 2010
Start date:	September 21, 2010
Revision date:	March 24, 2015

MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION

ORDER

On approval of the rules for maintaining a register of researchers conducting (conducting) clinical trials of medicinal products for medical use, and the procedure for posting it on the official website of the Ministry on the Internet

Document with changes made:
(Official Internet portal of legal information www.pravo.gov.ru, 04/22/2015, N 0001201504220034).
____________________________________________________________________

In accordance with Article 40 of the Federal Law of April 12, 2010 N 61-FZ “On the Circulation of Medicines” (Collected Legislation of the Russian Federation, 2010, N 16, Art. 1815, N 31, Art. 4161)

I order:

Approve the rules for maintaining a register of researchers conducting (conducting) clinical trials of medicinal products for medical use, and the procedure for posting it on the official website of the Ministry on the Internet according to the appendix.

Minister
T. Golikova

Registered
at the Ministry of Justice
Russian Federation
August 31, 2010,
registration N 18316

Application. Rules for maintaining a register of researchers conducting (conducting) clinical trials of medicinal products for medical use, and the procedure for posting it on the official website of the Ministry on the Internet

Application
to the order
Ministry of Health
and social development
Russian Federation
dated August 26, 2010 N 751н

1. These Rules determine the procedure for maintaining a register of researchers who conduct or have conducted clinical trials of medicinal products for medical use, and posting it on the official website of the Ministry of Health and Social Development of the Russian Federation on the Internet.

2. The register of researchers conducting or who have conducted clinical trials of medicinal products for medical use (hereinafter referred to as the register) contains information about specialists participating (participating) in clinical trials of medicinal products for medical use (hereinafter referred to as researchers, clinical trials).

3. The register is maintained on paper and electronic media by entering register entries into the register. If records on electronic media do not correspond to records on paper, information on electronic media is provided in accordance with the information contained on paper.

4. The register is maintained in accordance with uniform organizational, methodological, software and technical principles.

5. The registry entry contains the following information about the researcher:

a) last name, first name, patronymic;

b) place of work (full name of the medical organization);

c) position held;

d) specialty;

e) a list of clinical studies in which the researcher took part (periods of participation) as an investigator or co-investigator, work experience in clinical research programs;
(Subparagraph as amended, put into effect on May 3, 2015 by order of the Ministry of Health of Russia dated March 24, 2015 N 136n.

f) current status of the investigator (participating in a clinical trial, clinical trial suspended, clinical trial terminated).

6. Entry into the register of register entries is carried out within a period not exceeding three working days from the date of:

a) issuing permission to conduct a clinical trial;

b) receiving from the organization organizing the clinical trial a message about the completion, suspension or termination of the clinical trial.

7. The register is posted on the official website of the Ministry of Health and Social Development of the Russian Federation on the Internet and is updated daily, while maintaining the placement on the website of all previous editions of the register.

8. A backup copy of the register is formed in order to protect the information contained in it, at least once a month.

9. Protection of information contained in the registry from unauthorized access is carried out by built-in operating system tools and a database management system.

10. The information contained in the register is open and publicly available and is provided to any interested parties in accordance with the legislation of the Russian Federation.

Revision of the document taking into account
changes and additions prepared
JSC "Kodeks"

On approval of the rules for maintaining a register of researchers conducting (conducting) clinical trials of medicinal products for medical use, and the procedure for posting it on the official website of the Ministry on the Internet (as amended as of March 24, 2015)

Document title:	On approval of the rules for maintaining a register of researchers conducting (conducting) clinical trials of medicinal products for medical use, and the procedure for posting it on the official website of the Ministry on the Internet (as amended as of March 24, 2015)
Document number:	751n
Document type:	Order of the Ministry of Health and Social Development of Russia
Receiving authority:	Ministry of Health and Social Development of Russia
Status:	Active
Published:	Rossiyskaya Gazeta, N 204, 09/10/2010
Acceptance date:	August 26, 2010
Start date:	September 21, 2010
Revision date:	March 24, 2015