The law regulates the procedure for introducing drugs and new methods of treatment into clinical practice. Clinical trials are only conducted when the effectiveness and safety of a new drug or method has already been proven in experimental animal studies. Efficacy and safety are the main subject of research in clinical trials and require accumulation of factual material. Almost every medicine or treatment used in medical practice today has undergone clinical trials.

In recent years, an increasing number of people have received offers to participate in medical research. As a rule, these offers are received during hospitalization in medical institutions, but can be received in other situations. Each medical examination must have permission from a special commission to conduct it.

Patients are recruited only on a voluntary basis. Participation requires full knowledge, understanding and written consent. The explanation must be complete and include information about the effect, possible side effects, existing treatment alternatives, duration of treatment and follow-up, the extent of additional medical checks associated with the study (and their side effects), possible interactions with ongoing drugs.

Understanding the study design is essential. The most common is the double-blind method, which assumes that neither the patient nor the doctor knows what the patient is receiving in the course of treatment: the study drug or placebo (a substance that does not have biological effects). The single blind method assumes that the doctor knows and the patient does not know what treatment he is receiving. The study design may include a situation in which: a) the patient receives a drug tested for the first time; b) the patient receives a drug previously used for other indications, c) a drug known in medicine is used, but in a different combination, in a different context, in a different dose.

It is necessary to understand in what phase (stage) this clinical trial is. Phase I studies are first-in-man studies conducted in humans.

This stage of testing is designed to verify safety, side effects, dosage and preparation method.

In the second phase of research (Phase II), biological activity and effect are assessed in order to prove the concept of ‘proof of concept’, as well as to determine the optimal dose ‘definite dose-finding’.

Phase III evaluates the clinical efficacy of a drug or intervention.

Phase IV is post-marketing confirmatory research. This may include comparisons with peers and safety surveillance (pharmacovigilance).

Research is strictly regulated by law, which protects the interests of both the patient and the researcher. The patient can terminate his participation at any time. Participation in medical research can have both positive and negative aspects for the patient.

The arguments for participating in the study include: a sense of accomplishment of civic duty (after all, all the drugs and treatments that we use today were once introduced into clinical practice in this way), the possible benefits of a new drug (more strong effect), economic benefits (as a rule, a free set of drugs is offered for the entire duration of treatment), the possibility of easier contact with doctors, staff, certain advantages in the examination.

Arguments against participation include: unpredictable side effects (possibly serious), untested efficacy of this treatment, the need to exclude drugs with a proven positive effect from the treatment regimen, additional examinations and tests that have no individual clinical benefit. Sometimes the patient can turn from the object of treatment into the object of research, clinical interests can recede into the background, and interest in the patient can cool down sharply immediately after the completion of the research.

I would like to note that the decision to participate in a medical research is individual, depending on the type of research and personal life position. In any case, complete information about the study must first be obtained. The patient’s consent or refusal to participate in the study should not affect the attitude of the doctor towards him.