Infectious disease specialist Zuev Biography

Moscow, st. Sharik Podshipnikovskaya, d. Patients What is a clinical study? A clinical study is a scientific study in which persons take part in order to evaluate the effectiveness and safety of the drug or expand indications for the use of an already known drug. This procedure is an integral stage in the development of a drug that precedes its registration and medical use.

All clinical studies are conducted in compliance with the legislation of the Russian Federation of the Federal Law from following the rules that can guarantee that the rights of patients participating in the study are protected, and the results of the study are reliable. For what purpose are clinical research conducted? Modern medicine and pharmacy are actively developing, helping to increase the duration and quality of people's life.

Clinical studies are the most important part of the development of new drugs. Studies make it possible to understand how effective, safe, it allows you to find out its side effects and effect on the body. The initiators of clinical studies in most cases are pharmaceutical and biotechnological companies that directly participate in the development and analysis of the studied drug.

Pharmaceutical companies have the right to apply for registration of the drug only at the end of the clinical study, collecting the necessary data and a comprehensive analysis of their results. The drug may receive a refusal of registration if: its action was recognized as not effective enough; The drug was unsafe for a person; The company has provided an incomplete or inaccurate package of information about the results of a clinical study.

Thanks to clinical research, scientists improve knowledge about the disease, moving in the search for effective and safe methods of its treatment. If the research results confirm the effectiveness and safety of the drug, it receives registration in the country and doctors can prescribe this drug for the treatment and prevention of diseases. Why take part in clinical research?

Taking part in clinical studies, participants can learn about new methods of treating diseases before they become widely accessible. Thus, it becomes possible to receive the most advanced medical care in the treatment of the disease and contribute to the development of medicine as a whole. Who can take part in clinical research? Patients and healthy volunteers corresponding to the inclusion criteria that have no exclusion criteria specified in the research protocol may take part in clinical research.

As a rule, only patients with a certain disease can participate in studies, for the treatment of which the drug under study is intended. A set of healthy volunteers is possible only in the I phase of the study when the drug is used in humans for the first time. Phases of clinical research clinical studies take place in several stages of phases. The drug goes to the next phase of the study only if it showed effectiveness and safety on the previous one.

In the first phase, the studied drug is tested with the participation of a small group of people - a person. Doctors evaluate its toxicity, determine the safe dosage and side effects. In the II phase, the drug is studied in groups of patients. Its effectiveness in the disease is checked and the risks of its use are clarified in detail.

In the III phase, several thousand patients take part in the study in order to confirm its effectiveness in a larger population, as well as identify side effects and compare with standard treatment methods. Phase IV - studies that are carried out after registration of the drug. Their goal is to obtain additional information about the safety, effectiveness and optimal use of the drug. What happens during a clinical study?

A detailed research plan is described in the document called the research protocol. The protocol indicates the duration of the study, the criteria for the inclusion and exclusion of participants, the schedule of administration of drugs, etc. The list and schedule of examinations, tests and other procedures within the framework of the protocol of the clinical study are necessarily indicated.

Prior to the start of the study, the protocol must undergo an ethical examination and receive the approval of the Ministry of Health of Russia, the Ethical Committee of the Ministry of Health of Russia and the local ethical committee of the institution where research will be conducted. Ethical committees are called upon throughout the study to control the safety of research participants and monitor compliance with their rights.

All changes in the protocol, as well as in the documents that are intended for patients, are necessarily approved by ethical committees.The doctor introduces the patient to all aspects of the clinical study and, with the consent of the patient and in the case of the patient complies with the criteria for turning on and the absence of exclusion criteria, includes him in the study.

Throughout the study, patients should regularly come to the clinic according to the schedule of visits for examinations and testing. These procedures are necessary to assess the effectiveness of the drug and the safety of the patient. For the correct conduct of the study, it is necessary that all participants adhere to a schedule of visits described in the research protocol and in the patient’s informed consent.

The frequency and duration of visits varies depending on the research protocol. Signing the informed consent, the patient agrees with the proposed schedule of visits. Many studies are conducted on an outpatient basis in a medical institution. What is informed consent? Informed consent is the procedure for voluntary confirmation by the subject of his consent to participate in a specific study after receiving information about all the research aspects significant for his decision.

Informed consent is documented by signing and dating the form of informed consent. Before the patient decides on participation in the study, he is provided with complete information about him. After the discussion, the doctor provides the patient with a written form containing information about the study, including the objectives of the study, duration, procedures, possible risks and benefits, etc.

The patient has the right to familiarize themselves with the information and discuss the decision on participation in the study with relatives. By signing an informed consent, the patient confirms that he is familiar with information about the study, that his consent to participation is voluntary and conscious. The patient has the right to refuse to participate in the study at any time without explaining the reasons for the decision.

What is the duration of the study? Depending on the goals and complexity of the study, its duration can vary from several weeks to several years. The timing of the study is always stipulated in the protocol. Ethical committees observe the course of the study until its end. At any moment, the study can be stopped if the ethical committee considers that it is unsafe for participants.

What rights do patients participating in research have? No one has the right to force the patient to participate in the study. The patient has the right at any time and without explanation of the reasons to refuse to participate in the study. However, in some cases, for example, if a sharp abolition of the drug is a danger to the patient’s health, you cannot stop participating in the study immediately.

The patient has the right to receive all the information of interest to him regarding the study, the studied drug and the state of his own health in full and in an accessible form. Contact information of the doctor conducting the study is contained in informed consent. The patient has the right to the confidentiality of his personal data. All information about him is stored in an encoded form without the possibility of establishing his personality on it.

Medical documentation is available to a limited circle of persons, a doctor, employees of the sponsor company, controlling the conduct of research, auditors and authorized state bodies. During the study, the patient is under constant medical supervision. Each patient has the right to compensation for harm to health if it is established that the harm was caused as a result of participation in a clinical study.

What are the responsibilities assigned to a participant in a clinical study? The study is conducted in order to get answers to specific scientific questions. It is extremely important that the patient strictly follow all the instructions of the doctor. The patient is also obliged to inform the doctor about the symptoms that he appeared during the study, even if they seem insignificant to him.

How is the safety of research participants ensured? Before the drug is allowed to clinical research, it should undergo a stage of careful preclinical study of biomedical studies conducted without human participation as a subject, in most cases conducted on laboratory animals. All documents of the clinical study undergo a strict ethical examination before the start of the study and in its process.

Ethical committees check the facts of compliance with the documents of the study of ethical norms, the security of the study participants, and also evaluate the qualifications of doctors involved in the clinical study. Throughout the study, the health status of participants is carefully controlled by doctors: if the patient’s health worsens, he can be withdrawn from the study if necessary; He will also be provided with the necessary qualified assistance.

In accordance with the laws of the Russian Federation and international standards, priority during clinical research is the safety and well -being of patients. The storage of the material is carried out in accordance with the requirements of the manufacturer. A separate room is equipped with access to the archive of documentation of the research center. The abbreviated name Z.

The main state registration number 4.