Roster of Principal Investigators of the Ministry of Health. Conducting clinical trials of drugs

Clinical trials are scheduled before the sale of medical products is authorized drugs... The process consists of the following stages:

1. Study. Healthy volunteers are selected, the pharmacology of the drug is studied, its effect on the human body. The results allow us to determine what developments will be required in the future.
2. Working with sick participants. After establishing the fact that the drug is safe, it is tested on people who have characteristic diseases, syndromes. It is determined how effective the remedy is, how it helps.
3. Establishment adverse reactions... At this stage, the therapeutic values \u200b\u200bof the drug are determined.
4. Indications and dosage. It is determined how long the medicine can be taken, in what quantity, for what symptoms.

GlobalPharma Clinical Research Center has extensive experience in testing, detailed study of drugs.

What is offered to clients?

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

1. Development of a complete package of documentation required for the CT.
2. Development of detailed argumentation, calculations, sampling.
3. Preparation of the dossier, transfer 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 drawn up.

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, analyze the information.

There are two resources most often used to find 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 medical centers in Russia where the study is being conducted. The second is www.clinicaltrials.gov, the US National Institutes of Health's International Clinical Trials Registry. This resource is helpful for more details and important information research such as inclusion criteria, but it is being conducted on english language... Therefore, when looking for a clinical trial, we recommend using the two resources in parallel.

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

The following describes how to search for a study by specific criteria.

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

1. Recruitment - select Open studies (studies in which the recruitment of patients is already underway, or it has not yet begun, as well as extended access programs);
2. Study Type - select Interventional Studies;
3. Conditions - diagnosis in English;
4. Country 1 - Russian Federation (It should be noted that Russian Federation is not always indicated in the list of countries, therefore we also recommend re-performing the search without specifying the country);
5. Search - search.

Step 3. If your search returned results, you will see a list of studies matching your query parameters.

Step 4. You can get acquainted with more detailed information by clicking on the line with the research you are interested in.

Pay special attention for the following information:

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

Step 5. If you think that you have found a suitable clinical trial, the next step is to check if 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 Ministry of Health of Russia - see §1.

The study can be found by the protocol number listed in the "Other Study ID Numbers" row. If this line contains more than one protocol number, try alternate search.

Clinical trials are carried out only after obtaining a special permit from the Ministry of Health of the Russian Federation (MH 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 electronic form, pay a 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 lane, 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 trial protocol;

Investigator's Brochure;

Patient information sheet;

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

Information about medical organizations in which the clinical trial is supposed 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 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 a medicinal product for medical use produced for clinical trials;

A copy of the license for the production of medicinal products (for the manufacture of the drug 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;

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 in electronic form or on paper about the decision;

Prepares and submits to the Ethics Council and an expert institution (FSBI "NTs ESMP" of the Ministry of Health of the Russian Federation) a task for carrying out appropriate examinations. The expert commission and the Ethics Council draw up conclusions on the possibility or impossibility of conducting such a clinical trial and send these conclusions to the Ministry of Health of the Russian Federation within a period not exceeding 30 working days from the date of receipt of the assignment.

All allowed clinical researches are entered in the Register of Approved Clinical Trials and are available on the portal http://grls.rosminzdrav.ru.

Roszdravnadzor supervises the conduct of clinical trials ( federal Service on supervision in the field of health care http://www.roszdravnadzor.ru). 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 drugs intended for medical use.

Roszdravnadzor carries out:

Current and emergency checks of legal entities engaged in
organizing and directly conducting
clinical and preclinical research;

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

When conducting an inspection, authorized persons of Roszdravnadzor are also obliged to:

Not to prevent the head or an authorized representative of a certain entity performing the research organization from being present during the inspection and providing explanations on questions regarding the subject of the inspection;

On the facts of detected violations, take measures proportional to the severity of violations, their possible threat to human life and health;

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, as well as documents that can be obtained from other state control bodies.

Clinical research can be carried out only 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 the 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 Trials Management".

The manual is divided into eight Sections.

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

From my experience of working in a clinic, pharmaceutical company and the Regulatory Authority of our country, not every potential patient who can participate in clinical trials knows about the research being carried out. It is almost always a surprise for our patients when their doctor proposes participation in a clinical trial (CT), while changing the previous therapy of the disease to an experimental one.

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

For some, CI participation can be life-saving. WHO has released the rules according to which pharmaceutical companies and other research companies (CROs) must disclose 20 datasets when registering clinical trials they plan to start.

In developed and developing countries, Primary CI Registries already exist, which are properly executed (based on the requirements of the WHO and the International Committee of Medical Journal Editors (ICMJE)):

CI registry of Australia and New Zealand

Brazilian CI registry

China CI registry

India CI Registry

Cuban State Register of Clinical Trials

EU Clinical Trials Register

German Clinical Trials Register

Iranian Clinical Trials Register

Japan CI Register

CI register of the Netherlands

Pan African Clinical Trials Registry

Sri Lanka CI Registry

All CT specialists know that all new drugs must be validated in human clinical trials to test their safety and efficacy.

But those fatalities that occur during international CT tests could have been avoided by allowing everyone to get access to the history of testing a particular drug. Previously, when patients were included in the CT, no information was provided about tragic cases of the use of a new drug (MP).

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

A 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 contact WHO staff directly for clarification or assistance with the CI Registries Platform at:

World Health Organization

[email protected]t

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 drugs to record details of how this will be done.

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

There is great reluctance on the part of the pharmaceutical industry for 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 were not published in the CI Registry. Publishing research results in these journals is an important step towards obtaining FDA approval for new drugs.

WHO initiatives aim to bring together 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 web search based on a platform from which members of the public can obtain basic information about ongoing and completed clinical trials, including contact information for the study.

The aim is to increase transparency and accountability on the part of companies and institutions conducting clinical trials and, in turn, increase public confidence and confidence in the credibility of the company that manufactures new drugs.

There are a myriad of new avenues for targeted therapy in preclinical and early clinical cancer trials, and patients with refractory cancers often search online for these trials 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 EmergingMed.com, a resource for cancer patients, where you can post your profile in the system, and the search engine will strive to match your search for CI now and in the future. It is very simple and very effective.

For example, a patient with leukemia who began to develop resistance to the drug Gleevec began searching the Clinicaltrials.gov CI database for doctors. It was there that he discovered that he was currently undergoing CT on his disease 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 hometown, Rome. Italy does not have a CI Register. The man had no way of knowing what was happening on the threshold of his house.

20 items to be presented when registering clinical trials in the Primary Register:

Initial registration name and unique identification number

Date of registration in the primary register of CI:

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

Source of monetary or material support for KI

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

Secondary sponsors:

Contacts for general inquiries

Contact for scientific inquiries:

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

Scientific name of this study as indicated in the protocol

Countries of recruitment of patients

Nosology of diseases or conditions to be studied

Types of intervention

Main criteria for inclusion and exclusion of participants, including age and gender

Study type

First member recruitment date

Target sample size

Recruitment status (pending, currently recruiting, or closed)

Primary outcome

Main secondary outcomes

Ukraine has not yet created a Primary CI Register in a language accessible to patients. We hope that in the near future the Regulatory Bodies of our country will pay attention to the need to inform the public about the CIs being held in Ukraine.

Respectfully yours, Evgeniy Zadorin, Ph.D.