Obtaining permission for clinical trials in the Russian Federation - Journal of Pharmacokinetics and Pharmacodynamics. What clinical trials for cancer patients are currently taking place in Russia? Register of Approved Clinical Trials

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

The package of documents includes:

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

Clinical study protocol;

Investigator Brochure;

Patient information leaflet;

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

Information about the medical organizations in which the clinical trial is supposed to be conducted;

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

A copy of the compulsory insurance contract;

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 manufacture of medicinal products (when the drug is manufactured in the Russian Federation) or a copy of the conclusion on the compliance of the manufacturer of the medicinal product with the requirements of the Good Manufacturing Practice rules, issued by the competent authorized body of the country - the manufacturer of the medicinal product.

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

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

Makes a decision 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 in electronic form or on paper of the decision taken;

Prepares and sends to the Ethics Council and an expert institution (FGBU "NC ESMP" of the Ministry of Health of the Russian Federation) a task for conducting appropriate examinations. The expert examination and the preparation by the expert commission and the Ethics Council of conclusions on the possibility or impossibility of conducting such a clinical trial and the submission of 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 assignment.

All authorized clinical trials are entered 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 of 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 checks of legal entities engaged in
organizing and directly conducting
clinical and preclinical studies;

Obtaining and analyzing data provided by departments
Roszdravnadzor, on clinical trials.

Authorized persons of Roszdravnadzor, when conducting an inspection, are also obliged to:

Do not prevent the head or authorized representative of a certain entity that organizes 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, their possible threat to the life and health of people;

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

A clinical trial 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 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 guide consists of eight Sections.

Before allowing implementation medical devices are assigned to clinical trials of drugs. The process consists of the following steps:

1. Study. Healthy volunteers are selected, the pharmacology of the drug and its effect on the human body are studied. The results allow you to determine what developments will be required in the future.
2. Working with sick participants. After establishing the fact of the safety of the drug, it is tested on people with characteristic diseases, syndromes. It is determined how effective the remedy is, how it helps.
3. Establishment adverse reactions. At this stage, the therapeutic value of the drug is determined.
4. Indications and dosage. It is determined how long you can take the medicine, in what quantity, for what symptoms.

The GlobalPharma Clinical Research Center has extensive experience in conducting drug testing and detailed study.

What is offered to clients?

Cooperation is based on an agreement signed by both parties. The agreement confirms that the participants are not against conducting clinical trials. After the terms of the procedure are discussed, the design of clinical trials of the effectiveness of drugs. The contract research organization offers:

1. Development of a complete package of documentation required for conducting clinical trials.
2. Development of detailed argumentation, calculation, sampling.
3. Dossier preparation, submission of documents to the Ministry of Health.
4. Submission of documentation to the Ministry of Health, obtaining an expert opinion.
5. Formation of the final package of documentation, on the basis of which the registration dossier will be compiled.

Clinical trials in Moscow are carried out after obtaining permission from the Russian Ministry of Health. Employees will prepare the center, submit a request to the Environmental Control Laboratory, process the data, and analyze the information.

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 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 ongoing studies. It almost always comes as a surprise to our patients when their physician offers to participate in a clinical trial (CT), while changing their previous treatment of the disease to an experimental one.

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

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

Primary CT registries already exist in developed and developing countries, which are properly designed (based on the requirements of WHO and the International Committee of Medical Journal Editors (ICMJE)):

Australian and New Zealand CI registry

Brazilian CI registry

China CI Register

CI registry of India

Cuban State Register of Clinical Trials

EU Clinical Trials Register

German Clinical Trials Register

Iranian Clinical Trials Registry

CI Register of Japan

Register of CI of the Netherlands

Pan African Registry of Clinical Trials

CI registry of Sri Lanka

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

But those lethal cases that occur during international clinical trials could be avoided by allowing everyone to get access to the history of testing a particular drug. Previously, when patients were included in clinical trials, no information was provided on the tragic cases of the use of a new drug (PM).

It is in part to prevent such violations of patient rights that the WHO established the Global Network of Clinical Trials Registries (ICTRP)

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

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

Chinese

Dutch

German

Japanese

Korean

Persian

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

World Health Organization

[email protected]

The main goal of the network, known as the International Clinical Trials Registry Platform, is to increase transparency by requiring any company or institution conducting clinical trials of a drug to record how this will be done.

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

There is a great deal of 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 that have sparked public outrage.

Since September 2005, the International Committee of Medical Journal Editors (ICMJE) has refused to publish trial results that have not been published in the CT Registry. The publication of research results in these journals is an important step towards obtaining FDA approval for new drugs.

WHO initiatives aim to bring together participating CT registries around the world into one global network. This will provide a single point of access to the information they store and a web-based search platform from which members of the public can obtain basic information about ongoing and completed clinical trials, including study contact details.

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

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

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

For example, a patient with leukemia who has begun to develop resistance to Glivec began searching the CT database for clinicians at Clinicaltrials.gov. It was there that he discovered that he was currently undergoing a clinical trial for his illness in Canada.

He boarded a plane and when he arrived in Canada, he was informed by one of the researchers that an identical study was being conducted in his home city, Rome. Italy does not have a CI Register. The man did not have the opportunity to know what was happening on the threshold of his house.

The 20 items that will have to be submitted when registering clinical trials in the Primary Registry:

Primary Registration Name and Unique Identification Number

Date of registration in the primary Register of clinical trials:

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

Source of financial or material support for CI

General sponsor: person, organization, group or other legal entity responsible for the trial

Secondary sponsors:

Contact for general inquiries

Contact for scientific inquiries:

Public Title: Intended for the lay public in plain language.

scientific name this study as specified in the protocol

Patient recruitment countries

Nosology of diseases or conditions to be studied

Interventions

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

Study type

Date of recruitment of the first participant

Target sample size

Enrollment status (pending, currently enrolling, or closed)

primary result

Major Secondary Outcomes

In Ukraine, the Primary CT Registry 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 the clinical trials conducted in Ukraine.

Sincerely, Evgeniy Zadorin, Candidate of Medical Sciences.

MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION

ORDER

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

Document as amended by:
(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" (Collection of Legislation Russian Federation, 2010, N 16, art. 1815, N 31, art. 4161)

I order:

Approve the rules for maintaining the register of researchers conducting (conducted) clinical trials of medicinal products for medical use, and the procedure for posting it on the official website of the Ministry on the Internet in accordance with the annex.

Minister
T. Golikova

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

Application. Rules for maintaining the register of researchers conducting (conducted) 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 order
Ministry of Health
and social development
Russian Federation
dated August 26, 2010 N 751н

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

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

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

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 trials in which the investigator participated (periods of participation) as an investigator or co-investigator, work experience in clinical trial 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) the current status of the investigator (participates in the conduct of 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) issuance of permission to conduct a clinical trial;

b) receiving from the organization that organizes the conduct of 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 registry is formed in order to protect the information contained in it, at least once a month.

9. The protection of the information contained in the registry from unauthorized access is carried out by the built-in means of the operating system and the 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 the register of researchers conducting (conducted) clinical trials of medicinal products for medical use, and the procedure for its placement on the official website of the Ministry on the Internet (as amended on March 24, 2015)