I. Vlasova

Clinical Research  has stood out in a separate area of ​​interest of pharmaceutical industry and health care. This border area between business and the interests of the patient is especially vulnerable to ethical concerns. How reliable are the results of clinical trials and how to apply them in real medical practice? These problems are dealt within the framework of the Congress “Man and medicine,” the plenum of the Society of clinical research, today has 1.5 thousand members.

Experts noted that the number of trials held in Russia over the past three years has decreased somewhat. Even allowed to conduct research are not always implemented. According to scientists from 143 research stated in the Russian Federation in 2002, only 106 were made. In Russia, are not spelled out important research positions. For example, clearly specified the term “volunteer” does not exist under this definition of regulatory documents, are not regulated by the relationship of the Federal and local ethics committees (LEC).If the laws of many developed countries specified research questions of payment – 25% of the grant, the Russian Federation to pay directly to the researchers is prohibited.

There is another aspect that seems to be “slow” conducting clinical trials. At close to us, or Ukraine, for example, in studies conducted in Poland is much larger, there is the passage of the applications through the permitting authority and control, respectively, 50 and 42 days. According to a survey conducted last year at the request of eight IPM producers drugs in Russia, this period is equal to an average of 150 days. And more than half the time the documents were not the experts, and on the desks of officials. Given that one day the development of CI is the manufacturer $ 1.5 million, one can understand why the study moved to a more mobile, although “less professional”, according to Professor led the plenum. YB Belousova, territory.

He also, incidentally, noted that the educational programs, taking into account the legal and ethical niceties, prepared with the participation of producers, would not hurt to educate both the existing civil servants and students, who will still take including and official positions.

The new requirements came from the Ethics Committee of Medical University.In particular, the committee recently began to carry out the decision of the HAC ethical review of theses. Taken into service experience of inspection by the FDA in the U.S., the person who committed many ethical violations during the procedures of registration trials, even in the absence of a quorum make ethical decisions, etc. Online Medical University Ethics Committee is comprised of 15 professionals, including lawyers and clerics. In 2002, there were examined 44 clinical trials protocol, and 18 theses. It was forbidden to a study for testing drugs for alumni of one of the orphanages.

Legally enforceable requirement of informed consent of research participants have already seen doctors with understanding, though not always implemented in practice yet. This is especially important for vulnerable patients, for example, for sick children. Naturally, the risk of CI and invasive procedures should be minimized. Do not just bring the baby to scientific information and to obtain his consent, as required to explain the features of upcoming studies, their usefulness and risk, “according to the development of” a little patient.Nevertheless, both parents and child should understand what to expect from the proposed trials for treatment. And still have to give explanations, because, according to the Family Code, the agreement and disagreement on matters relating to his interests, may make the child is already 10 years old, not to mention the need for parental consent. Inattention to the ethical issues of CI leads to litigation. Thus, in one of Moscow’s maternity hospitals filed a lawsuit in connection with the disease 2.5 years of a child: he introduced the drug in the perinatal period without parental consent and a dose not shown to children under the age of 1 year. It is likely that now the child’s parents win the case.

No less carefully stipulated special conditions should be studies conducted in pregnant women. Ethical review in this case should consider questions in whose interest it is carried out clinical trials, the mother or child, whether in that case the informed consent of the father. Speaking generally about the approach to research genternom drugs that today many of the drugs, prescription women who were never tested in this population and may provide other, different from men, the clinical effects.

Many disputes and problems caused by bioethical drug research involving military personnel. On the one hand, many pharmaceutical companies are interested in them, since the result may be government purchases drugs. But this social group vulnerable is in a subordinate position in relation to departmental medicine, law, and because clinical trials in this social group are prohibited. Nevertheless, a direct question to the participants of the plenum of the need for research personnel voiced unequivocal “yes”, but only in the field of preventive health care …

Interest in the problems of CT to improved medical practice, the ethical aspects of contemporary research is great enough – the hall was overcrowded.

It should be noted that regulations relating to clinical trials, will probably soon corrected in accordance with the RF Law “On technical regulation”. According to JB Belousova, have already been created for the few teams with the participation of authoritative scientists of the RAS and RAMS. And on October 15 in Moscow will host the 3rd International Conference on clinical trials that will address issues related to the legal background of the CI, the prospects for multicenter studies, the safety of drugs and dietary supplements, the principles of clinical trials of immunobiological, homeopathic, psychotropic drugs, and relationships these studies with evidence-based medicine.

Article published in Pharmaceutical Bulletin


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