According to international protocols
Ada Gorbacheva, Nezavisimaya GazetaIn the second half of the last century, there was a qualitative change in the creation of medicines.
New tools allow you to cure diseases that were considered fatal until recently. And there are more and more such defeated diseases.
The development of a new drug sometimes lasts for years. The final stage is clinical trials. However, not only new, but also any medicine, before it is registered by the Ministry of Health, even if it has been used in other countries for many years, must necessarily pass clinical trials. Patients who have entered the program of such tests believe that they are lucky: they receive a drug, which they will then have to get discharged for free or buy it for a lot of money.
Testing a completely new drug is an incomparably more complex process. First, careful experiments are carried out on various types of animals. Then comes the first phase of clinical trials. About a dozen people participate in it, usually among them are the creators of a new drug who take the greatest risk. There are significantly more participants in the second phase of the trials, and thousands of people can participate in the third.
There is always a risk from taking any drug, even if it has been present on the pharmaceutical market for a long time, explains Candidate of Medical Sciences Alexander Alfimov, director of research at one of the largest European pharmaceutical companies. There is also a risk when participating in clinical trials, but this risk is controlled. The first way to reduce risk is to limit the number of participants. The second way is to carefully monitor the conduct of research in accordance with the protocol. Any research is always carried out according to the protocol. The protocol is a document containing 200 pages of text, mandatory for all phases of testing. It is approved by the Ministry of Health, ethics committees and within the pharmaceutical company conducting the study. It provides for careful observance of the interests of patients, all methods of monitoring their condition and minimizing risk. The third is monitoring the progress of the study: intermediate results are always studied. If they are not better when using a new drug than when using a previously used one, the monitoring committee immediately stops testing.
The risk of taking the drug during clinical trials, paradoxical as it may seem, is significantly less than when taking a drug purchased at a pharmacy. After buying a medicine, the patient takes it and takes it without doing regular tests, and the medicine may not have any effect anymore. Meanwhile, the drug affects each person individually, emphasizes Alexander Alfimov. A good doctor, prescribing registered medications, should constantly monitor the patient's condition and, in case of side effects or insufficient effect, immediately cancel the medicine and replace it with another. This, in fact, is the art of the doctor. Now a new direction of science has emerged – pharmacogenomics. Knowing the genotype of a person, we can assume how a specific medicine will act on him. But this direction is only developing. In the meantime, they proceed from averaged data.
Mandatory conditions for clinical trials are the informed consent of the patients taking part in them, the supervision of ethical committees. To establish the effectiveness of the new remedy, some patients receive it, some receive standard treatment. Neither the doctor nor the patient knows about who receives what remedy. This becomes clear only after the completion of the study. But no one remains without treatment – it is very strictly regulated.
What are the guidelines for patients who agree to participate in clinical trials? First of all, it is an opportunity to receive a new (usually very expensive) effective remedy before it is registered and appears in the pharmacy. This happened, for example, with patients with chronic myeloid leukemia, who were treated with a new drug during the study, which literally saved their lives with this fatal oncohematological disease. Secondly, access to very high-quality medical care regulated by the research protocol: the tests are carried out by highly qualified research doctors in a good medical institution. Thirdly, the desire to help other people suffering from the same disease. Patients are included in studies not by acquaintance, but by diagnosis. Those interested can take the initiative and find information about conducting research on their disease on the official websites of the Ministry of Health.
Russian doctors conducting tests are attached to the standards by which they work in world medicine, they cease to feel their isolation from it.
Clinical trials of new drugs are conducted according to the same protocols in different countries. Russia also participates in them, but not much: it accounts for 5-10% of the research volume. We can say that Russian patients use the data obtained on Europeans and Americans. Unfortunately, there are no domestic medicinal products among those undergoing international research. And this is not the fault of Russian scientists. They are just successfully developing new drugs, but not in their native rich country, in which science is begging.
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13.03.2008