Ethical problems of randomization. Clinical balance
Randomization as a key procedure in a clinical trial in itself creates ethical problems. Let's imagine that a clinical study of a new drug is carried out in a group of patients who really need medical help. Under what conditions does the doctor, having obligations of good to the patient, have the right to use his patients for clinical research, including using random distribution of them into groups?
The concept of clinical equilibrium is an attempt to answer this question. The notion of clinical equilibration (clinical equipoise) was introduced by Benjamin Friedman in 1987. Since then, this concept has been a developing and widely discussed topic in bioethical literature, although, of course, it has its critics. In brief, its main points are as follows.
The condition for including patients in a clinical trial is a significant uncertainty about which of the two treatments (standard or new) is more effective. Of course, if there is reliable data in favor of some method (ie, disequilibrium), the medical ethics require that the attending physician prescribe to his patients more effective treatment.
Actually, the purpose of the clinical trial is to break the initial uncertainty to shift the balance in one direction or another.
Uncertainty or doubt must exist within the professional medical community. The doctor himself, of course, may have his own preferences in favor of a particular treatment, but he must take into account the significant disagreement at the level of the medical community (Figure 4.2).
Fig. 4.2. Clinical balance:
A - the new method: B - the standard method
As a participant in the study, the doctor is obliged to seek the purity of the experiment. To do this, he should restrain his own opinion and follow all the methodologically rigorous procedures for participating in the experiment. He should formally support the assumption of clinical equilibrium when conducting a clinical trial.
In these circumstances, the randomization procedure not only expresses the demand for scientific methodology, but is also ethically justified, since the doctor gives equal chances to his patients to receive one or another treatment option. In this way, he realizes the moral principle of justice for his patients. But once again, we should pay attention to the fact that clinical research should be caused by scientific necessity and the presence of significant uncertainty in the medical community (and not by any other considerations, for example, commercial ones).
Attending physician and researcher: role conflict
The difference between medical practice and scientific research was described above. Because of the significant difference in the values, goals, methods of these two areas of the doctor's work, when he speaks to his patients simultaneously, both as a doctor and as an investigator, a certain conflict of roles may occur, including a conflict of ethical principles.
The doctor involved in the study should ensure that the study is carried out according to the standards of scientific methodology, but at the same time observing all the requirements of medical ethics and protecting the interests of the patient.
One of the main difficulties of this dual role is that the doctor often has to make medical decisions in favor of the patient during the research. For example, if a doctor participates in the double-blind clinical trial, he is unaware of what medication his patients receive, which can affect his decision-making and the patient's health.
As a result, either the interests of the study or the quality of the treatment suffer (or both).
The main tasks of a physician involved in clinical research include the following:
1) make sure that research is justified by scientific necessity and follows the necessary methodological standards;
2) take care of the maximum risk reduction for patients;
3) in all situations, strive primarily to benefit the patient, including when necessary to remove the patient from the study;
4) to oppose any means of exploitation of research participants, as well as to inequitable distribution of benefits and risks;
5) comply with all standards of research ethics in relation to the protection of the rights of test subjects.
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