How and why clinical trials are conducted

Clinical studies

Marianna Mirzoyan, Mednovosti

The material is published in partnership with the project "Medicines for Life", dedicated to improving the pharmaceutical literacy of patients.A clinical trial is the only way to prove the efficacy and safety of a new drug.

All tests are conducted in compliance with special international rules of good clinical practice (GCP – Good Clinical Practice). Following the GCP rules serves as a guarantee that the rights of patients participating in the study are protected, and the results of the study are reliable.

Patients' rightsThe doctor introduces the patient to all aspects of the clinical trial and, if the patient agrees, includes him in the study.

Patients should come to the clinic regularly for examination and tests, their well-being is monitored.

A detailed clinical trial plan is described in a document called the study protocol. It specifies the duration of the tests, the criteria for inclusion and exclusion of participants, the schedule of taking medications, there is necessarily a list and a plan of examinations and tests. The protocol is developed by the customer of the study – as a rule, it is a pharmaceutical company.

In Russia, before the start of the study, the protocol must pass an ethical examination and receive approval from the Ministry of Health of the Russian Federation. Throughout the study, ethics committees monitor the safety of participating patients and ensure that their rights are respected.

Placebo-controlled studiesFor ethical reasons, the use of placebo in clinical trials is limited.

In accordance with the principles of the Helsinki Declaration of the World Medical Association, the benefits, risks and effectiveness of a new treatment method should be evaluated in comparison with the best available treatment methods. Exceptions are cases when there is no effective way to treat this disease or there are compelling scientifically justified reasons for using placebo and patients will not be exposed to serious health risks.

Post-marketing researchIn Russia, the order of the Ministry of Health approved the procedure for reporting identified ah medical devices.

According to the order, it is necessary to report in writing or electronically about any side effects not specified in the instructions for use, "facts and circumstances that endanger the life and health of citizens and medical workers." The e-mail message should be sent through the official website of Roszdravnadzor or through the portal of public services. The message must contain the contact details of the company or individual who discovered the side effects, the name and manufacturer, as well as a description of the undesirable effect of the medical device. Such information must be reported by a doctor within 20 working days from the moment of their detection. It should be noted that the notification form is designed for people with medical education. Patients who have independently identified undesirable reactions or the absence of the expected effect of the drug have the right to demand from the attending physician that he fill out the form, you can send the notification yourself.

As a rule, when new side effects are detected, information about them is added to the instructions for the medical use of the drug and is brought to the attention of the public through letters, through health consultants and other types of education. In some cases, the use of the drug should be restricted, and in rare cases, the drug should be withdrawn from the market.

Portal "Eternal youth" http://vechnayamolodost.ru15.01.2014