Clinical researches

Clinical researches

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Choosing a medicine in a pharmacy, we simply do not think about how long it will take for him to go to the shelves. It was this fact that gave rise to a series of myths that expose sinister pharmaceutical companies and pity the "deceived" participants in the experiments.

Pharmaceutical companies around the world are secretly testing their new drugs on humans. Has anyone thought about whether there is any point in secretly conducting clinical trials? Research into new drugs is not an end in itself for pharmaceutical corporations. Conducting clinical trials around the world is a mandatory stage in the development of the tool itself, even before its registration and widespread use. In the course of such studies, specialists study in detail the effect of a new drug, obtaining all the necessary data on its effectiveness and safety. And on the basis of the results already obtained, the body authorized by the state (in Russia it is the Ministry of Health and Social Development) decides whether to register a product or not. The drug that has not fully passed clinical trials, in principle, cannot be registered and put on sale. At the end of the entire series of studies, the company conducting such tests approves the study protocol with the notified body. This document details the objectives, methodology and procedures for all ongoing trials of a new drug. In Russia, the Ministry of Health and Social Development publishes on its website all the official information about what approvals have been issued to conduct clinical trials. In this case, the protocol number, the name of the studied drug, the sponsor, the duration of the study and those centers that conduct the experiments are indicated. The number of participants in the experiments and its current state are also indicated. As new information becomes available, the register on the site changes. This information is publicly available and everyone can get acquainted with it. Thus, there is no need for companies to conduct any secret tests.

Clinical trials are carried out by pharmaceutical companies only in developing countries, where there is less strict legislation and low taxes. Such regions are a kind of testing ground. Statistics states that during 2009, 577 licenses for conducting clinical trials were issued in Russia, 348 of which are international, passing in parallel in other countries. During this year, more than 17 thousand studies were launched all over the world, of which more than 7 thousand were in the United States, and 4600 were in Europe. The picture is quite indicative, in Russia in this way only slightly more than 3% of the total number of clinical trials conducted on the planet are carried out. Recently, there has indeed been a tendency to transfer some of the international research to developing countries. The reasons given are quite simple and logical - low cost. However, this is not always the case. For example, in Russia, the cost of research is already approaching European prices due to customs duties, spending on logistics and expensive interagency approvals. The increase in research in Africa, Latin America and Eastern Europe is a consequence of the fact that the size of this market and its potential in developed countries are close to being exhausted. This is due to the growth of research activity, so in 2009 in the United States there were 1.5 times more applications for registration of new drugs than in 1999 and the tightening of requirements for new drugs. As a result, the duration of the studies increased by 70% from 1999 to 2005, and the number of participants during the same period increased more than 7 times (from 2.8 to 19.8 million)! It is logical to assume that over time, it becomes more and more difficult to recruit new members. The timing of patient recruitment comes to the fore, and this time frame in developing countries is noticeably lower than in Europe and the United States. The rate of recruitment of patients from 1999 to 2005 in developed countries fell by 30%, this was due to the fact that only in the United States only 7% of clinical trials begin on time. In England, 30% of centers generally cannot find at least one patient for their research. In the USA, Europe and Japan, where a high standard of living and developed insurance medicine, any patient has the opportunity to receive high-quality treatment based on modern technologies and medicines. And in developing countries, participation in clinical trials is the only way for many patients to receive medical care and expensive treatment. It is impossible to create a testing area and include exclusively developed countries in it - it simply does not have the required number of patients. And this will entail either a delay in the release of drugs to the market, or a freeze of their research. And there is no need to talk about imperfect laws and poor control over research in developing regions either. All international multicenter studies use a single international ICH GCP standard, its implementation is necessary for the subsequent registration of products in almost all countries. And in Russia, this standard is part of the GOST. The quality of the clinical trials conducted in our country is confirmed by repeated checks by the inspections of Western countries. In 2008, 81 drugs were approved in the United States, 34 of which were partially investigated in Russia, in Europe the figures were 35 out of 85.

Clinical trials are generally not safe for humans. In addition, companies conduct tests of the first phase, the most dangerous for humans, in developing countries. Consider first how drug trials work. First, preclinical studies are carried out in animals and biological models. Then comes the very first phase of clinical trials. Its purpose is to understand the portability of the agent, and here for the first time a person participates as an experimental. At this stage, work is carried out with a small group of healthy volunteers, up to 100 people. For a number of diseases, such as cancer, the first phase is tested on already sick people who simply have no time to wait. The second phase already involves several hundred volunteers suffering from the disease, which they are trying to defeat with this drug. During the third phase, the number of volunteers increases to several thousand. At this stage, statistically reliable data are already being collected, which confirm the safety and effectiveness of the drug. The second and third phases are usually carried out in the form of international studies in different centers, with the participation of patients from different countries of the world. Of course, the most unsafe for humans is the first phase, since the medicine has not yet been used on a person before. Such studies are carried out exclusively in special clinics or hospital departments with modern equipment and a full range of necessary medicines. At the same time, there are rather stringent requirements for the equipment of clinics conducting phase I studies. All volunteers are in the hospital under the constant supervision of highly qualified personnel. And against the myth of testing on poor Africans speaks at least the fact that 76% of the experiments of the first phase are carried out in the USA, Canada and Holland. This is largely due to economic considerations, because there is simply no point in distributing a small number of participants to different countries. And licensing procedures are much simpler here. But in Russia, since 2010, it is generally prohibited to conduct tests of the first phase of foreign drugs with the participation of volunteers.

In clinical trials, patients act as experimental subjects that no one cares about. To date, all research is conducted on the basis of high ethical standards, at the head of which are harmlessness and complete voluntary participation. The priority of the well-being of the experiment participant is always above the interests of society and science. Such ethical standards for conducting clinical trials were laid down at the Nuremberg Trials in 1947, all subsequent documents only emphasized and supplemented those provisions. International research practice is guided by two documents - the Declaration of Helsinki, adopted at the 18th General Assembly of the World Medical Association (WMA) and the already mentioned ICH GCP. There are also other important documents - the Council of Europe Convention on Human Rights and Biomedicine (Oviedo Convention) and the Additional Protocol on Biomedical Research. Voluntary participation in clinical trials in Russia is stipulated in Article 21 of the Constitution: "No one can be subjected to medical, scientific or other experiments without voluntary consent." An informed consent process is used to implement voluntary participation. The experiment participant is provided with all the information about the goals of treatment and methods, the possible benefits and potential risks. The patient signs a form stating that he has read and understood all the information about the study. In turn, the doctor certifies that he has provided the patient with all the necessary information. The agreement provides for the possibility of the subject leaving the experiment at any time without explaining the reasons. Research is conducted only when the expected risks to the patient do not exceed the potential benefits. In general, all over the world, clinical research is strictly controlled by society and the state. In Russia, both the research protocol itself and all the documents provided to the experiment participant are approved by the Ministry of Health and Social Development. And various ethical committees, auditors and monitors are closely watching the course of the experiments. So there is no doubt that a patient participating in clinical trials is under the closest supervision of highly qualified specialists and gets access to the most necessary drugs and technologies.

Patients in the control group are given a placebo (dummy medicine), which poses a threat to health and life. In modern practice, clinical trials are predominantly comparative. One group of patients takes the study drug, and the other, the control group, takes the reference drug. It is this approach that allows you to get the most reliable results. In this case, the new drug is compared with the standard drugs in this case or with a placebo (dummy drug). In accordance with the principles of the Declaration of Helsinki of the World Medical Association, all risks, benefits and disadvantages of new techniques must be compared with the best available treatment methods. The exceptions are cases where the use of a placebo and no treatment is warranted because there is no effective treatment. Another option is the existence of compelling and well-founded reasons for using a placebo or the safety of the treatment used. The declarations state that special measures must be taken to avoid inappropriate use of placebos. Pharmaceutical companies take into account both scientific and ethical aspects even at the stage of research planning and development. This work involves not only physicians, but also statisticians. And finally, the question of the specific use of placebo is decided only when conducting an ethical examination of the entire commission.

Patients participate in clinical trials solely for the purpose of earning money. Payment is made only to healthy volunteers and only in the first phase of clinical trials, when it is obvious that there will be no benefit from the drug for them. But the participation of volunteers in subsequent phases is usually no longer financially stimulated in order to eliminate any pressure on the patient and give him the opportunity to weigh all the risks and benefits associated with participation in the experiments. Sometimes clinical companies offer their patients reimbursement of travel expenses to the clinic for the examination during the second and third phase trials, but nothing more.

Clinical research is not particularly needed. To release a drug on the market, enough information obtained in the course of preclinical tests on biomodels and animals. Wouldn't humanity refuse clinical research if it could be done? Human research is done precisely because the results needed cannot be obtained from animal research or modeling alone. Practice has proven that one cannot simply transfer the results of preclinical studies on animals to humans. According to the Association of Research Organizations and Pharmaceutical Manufacturers in the United States, out of 10,000 drug candidates in the modeling and early testing stages, only 250 candidates move to the next stage. If these 250 funds take part in preclinical studies, then only 5 of them reach clinical trials. As a result, only one drug passes through all phases of research and receives the approval of state bodies, getting the opportunity to be called a medicine. If we simply allow the registration of those drugs that have successfully passed preclinical studies, then about 80% of them, entering the market, will be either ineffective or harmful to humans.

Clinical trials involving children, the mentally ill and other vulnerable populations should be prohibited. In fact, it is imperative to conduct clinical trials with children and the mentally ill in order to develop new pediatric drugs and medicines to combat mental illness. If such research is banned, then there will be no new drugs for such patient groups. It is impossible to simply extrapolate the effect of "adult" drugs on babies by giving them smaller doses. After all, children are not small adults, their organisms are developed in a completely different way. The use of adult drugs on children is dangerous, because different pharmacokinetics and pharmacodynamics are used here, as well as different efficacy and safety profiles. And often children need other dosage forms than adults. And it is generally pointless to conduct research on psychotropic drugs on healthy people, since it will then be impossible to assess their effectiveness. And it makes no sense to use drugs with unproven safety and efficacy in wide medical practice. After all, it will turn out to be essentially the same clinical study, but only much more widespread and uncontrolled. The rights of incapacitated participants in experiments, as well as minors, are protected by both the Declaration of Helsinki and the principles of the GCP. These documents set out the ethical standards for conducting clinical trials with the use of vulnerable groups of people. Naturally, when conducting tests with such groups, additional measures are required to ensure the safety of research subjects.Sometimes it is impossible to obtain consent directly from the participant in experiments; in such cases, declarations require that consent be given by his legal representatives. In addition, the Declaration of Helsinki states that if an incapacitated patient is able to express his own attitude to participation in experiments, then the doctor must request it in addition to the consent of the official representative. In the ICH GCP, such norms are spelled out in even more detail. Also, when deciding whether to conduct such research, one should take into account the responsibility of ethics committees to pay close attention to such processes. Obviously, global norms do not prohibit research at all. Everyone understands that this is a natural and necessary process. It is simply necessary to strictly adhere to a number of conditions, without raising the question of the complete exclusion of a category from research. In Russia, in parallel with the international norms of the experiments themselves, there is also a system of protecting the rights of disabled patients at the level of laws. Thus, the law "On psychiatric care" stipulates that persons to whom compulsory medical measures have been applied, in principle, cannot be participants in clinical experiments. But it is impossible to legally prohibit conducting research with disabled persons - this would be a violation of their rights. The same Declaration of Helsinki states that “populations that are not sufficiently involved in medical research should be provided with an appropriate opportunity to participate”.

There is a conflict of interest between the need for the strictest control over clinical trials and the commercial interests of pharmaceutical companies. First of all, let's talk about the commercial interests of pharmaceutical companies. The drug manufacturer seeks to register it and bring it to markets, which will recoup development costs and make a profit. To carry out these steps, the approval of the competent health authorities is required. In advanced countries, when deciding on the registration of a new product, the employees of the authorized bodies not only check the reports on the studies carried out, but also inspect the clinics where they were carried out. Thus, the work of doctors is assessed. If, at the same time, inconsistencies with strict international standards are noted, then the results are simply canceled, and the drug is not registered. At the same time, the company itself bears big losses. In almost all normal countries, and Russia is no exception, there is a certain order of control over drugs that have entered the market. If a company has poorly studied the safety of a new drug even before its release to the market, and extensive monitoring has revealed violations, then registration will not happen. And this is fraught not only with financial losses, but also with a deterioration in the company's reputation. If the drug is registered and its widespread use is safe, but ineffective, then it will be difficult to ensure its widespread use and distribution in medicine. After all, such a drug will not have an advantage over analogues, which will give it a small market share, depriving the company of profits. Of course, in each country, the commercial success of a drug depends on many factors - from the traditions of traditional medicine to the country's health policy. However, for leading pharmaceutical companies targeting Western markets, compliance with all ethical and scientific standards is a sine qua non for commercial success.

Watch the video: Skeptical Journal Club: How To Read A Medical Study (August 2022).