Clinical trials

What is "clinical research"? Why should patients take part in them?

The main advantage of participating in a clinical trial is that you will be able to access new drugs that may work better than existing ones.

How safe and effective the new drug is, no one knows — it is in order to find out, and a study is being conducted. However, you need to understand that the research of a particular drug goes to the clinical stage only after the preclinical trials have been successfully completed: laboratory experiments in test tubes, on human cell cultures, on mice, on other animals. Conducting human trials is expensive, and pharmaceutical companies only decide on clinical trials if they believe in the possibility of success and have studied the safety of the drug.

The modern standards of clinical trials are based on the principles of voluntariness and maximum information of participants. The ethical principles on which research should be conducted are set out in the Helsinki Declaration The World Medical Association, adopted in 1964 and has since been regularly updated. The consent of the participants, according to the document, must not only be completely voluntary, but can also be withdrawn at any time without giving a reason. In addition, everyone who agrees to be part of the study should clearly understand: what exactly is being investigated, what is its own interest to participate in, and what risks it carries in doing so.

It is only necessary to participate in the study when the expected benefits of using a new drug may be higher than the expected risks. So it is or not in your case-you will have to decide for yourself, after consulting with your doctor.

Sometimes, especially in severe cases, participation in research is the only chance. If the existing, already registered drugs do not work in your case, then either only palliative care or participation in a clinical trial remains. Then even a small chance of success is better than nothing.

In addition to this main argument, there are additional advantages: participants in clinical trials are thoroughly diagnosed, their treatment is scrupulously followed by the protocol of therapy (usually developed by the world's best specialists), throughout the entire period of participation in the study, you are under the careful supervision of specialists participating in the study.

The financial issue should also not be forgotten: you will not be charged for treatment with new drugs. All examinations will also be conducted free of charge within a strictly defined time frame.

Clinical trials are conducted on the basis of:

For Russian patients, there is another plus: in accordance with the law of 2010 "On the circulation of Medicines", any foreign drugs, even those that have already passed all the tests, must undergo repeated (local registration) tests in order to be registered. Russia. This makes it possible to get the most modern and already tested and registered medicines in other countries for free.

In the departments of the State Medical Institution of the MCSC named after A. S. Loginov DZM, clinical studies of different phases are conducted, initiated by foreign and domestic pharmaceutical companies. Monitoring of compliance with the patient's rights is carried out by the Ministry of Health of the Russian Federation and the ethics Committee of the center.

For questions concerning the conduct of clinical trials in the State Medical Institution of the MCSC named after A. S. Loginov DZM, please contact the department of clinical research organization: ooki@mknc.ru