Clinical studies of drugs: what it is and how they are carried out, therapy, medicines

Without clinical trials, no drug can get to the consumer - this is the law, one for all pharmaceutical companies. We often hear that some kind of new drug passes clinical trials, but we know little about what it is.

Election of a new drug for the pharmaceutical market — The process is complex. To interest buyers, the manufacturer conducts an advertising campaign, describes the effects of medication and its advantages, emphasizing every time that the new drug has passed all the necessary tests, including clinical. What it is? How they are held and who participates in them?

What is a clinical study?

Clinical studies of drugs: what it is and how they are spent Clinical study — This is a scientific study of the medicinal product in which living people participate. This is the only way to prove that the new medicine is efficient and safe for humans.

Clinical study — Final stage of the development of any medicinal drug. During the test, scientists confirm that the drug created by them causes the desired effects, receive information about its side effects, conclude that caution should be exercised during treatment, and who should refuse him at all.

After analyzing the results of a clinical study, a pharmaceutical company submits documents for state registration of a new drug. If in view of insufficient efficiency and safety of the drug in registration will be denied, the drug will never see the light, but even in this case the experience gained during tests will be valuable for science. If the medicine is registered, its mass production will begin, and it will be used in the treatment of patients.

Without clinical trials, no medical drug can get into hospitals and on the shelves of pharmacies — such is a law, one for all drug manufacturers.

On com have medicines?

Choice of clinical research participants — Dropping process. During the tests, special international rules must be respected according to which «Extensive» must be protected from undesirable effects of experimental medication.

When selecting participants, their age, gender, the presence of certain diseases, stage and features of their flow, preceding treatment and many other factors. As a rule, the study does not include pregnant and nursing women, except in cases where the new medicine is intended for use in obstetrics. When testing some drugs, patients with diseases are excluded, in which side effects can occur with high probability.

The selection of participants is not discriminatory, its goal — Safety of people and getting the highest possible information about the preparation.

Phases of clinical research

Prior to clinical trials, the drug is thoroughly examined in the laboratory, first in the test tube, and then animals. Only if these studies have confirmed the declared efficacy and safety of the new fund, it goes to the clinical trial stage, where it is consistent, step by step passes all the necessary steps.

I Phase — The future medicine is tested on healthy people, usually this is a group of 20–80 people. Purpose of the study — Estimate the degree of toxicity of the new drug, determine its safe dose, identify the most significant side effects.

II phase — The drug is tested for 100–300 patients, its action is checked at a certain disease and the risks of its application are evaluated.

III Phase — Several thousand patients participate in the study, it allows you to track rare side effects and compare a new drug with already existing similar drugs.

IV phase — This is the phase of postmarketing research, which are held when the drug has already enrolled on sale. Target — clarify the existing and get additional information about the medicine.

Types of clinical studies

Comparative studies are carried out to compare a new drug with already existing drugs. At the same time, some patients receive treatment with a new drug, others — Old.

Blind studies — These are studies in which neither the doctor nor the patient know that a new, experimental drug is applied to treatment. Simple blind research implies only the patient's ignorance.

Research is open, if a doctor and patient aware of the tests of the drug.

Placebo-controlled studies imply the division of patients into two groups, it gets instead of medication «Paves», that is, indifferent drugs that do not affect the state of health.

Randomized studies — These are the trials with the random distribution of participants in groups. At the same time, the subjectivity of the choice of patients comes down to a minimum, which means, the results are more reliable.

How is a clinical study?

Initially, a pharmaceutical company representing a new drug is a plan, that is, the Study Protocol in which all the rules must be written in detail to comply with its participants — Doctors and patients. The protocol passes ethical examination and receives the approval of the Ministry of Health — This is a guarantee that during tests all rights of patients who participate in it will be observed.

After acquaintance with the protocol of research and patients, work begins. Doctors prescribe a patient necessary treatment, patients strictly comply with the recommendations of doctors, take the drug, lead a reception diary and regularly visit the clinic to examine and pass the necessary assays.

Most clinical studies are conducted outpatient, that is, the patient takes the drug at home, and the clinic comes only for inspection, surveys and report on its feelings and observations.

The duration of the clinical study is regulated by the manufacturer. Some medicines are investigated a couple of weeks, others are tested for years. It all depends on the purposes pursued by the testes, and the complexity of the tests themselves.

Rights of clinical research

It is not necessary to compare a clinical study conducted with the participation of people with the test of the drug on mice or guinea pigs.

Participation in the study — The business is voluntary, that is, the patient himself decides, take him a new drug or not.

In the course of the research, complete confidentiality is observed: no one will ever recognize the name of the patient, all the information is encrypted and not available to outsiders.

Each study participant is informed about the purpose of testing, about the procedures and surveys that it will have to pass on the analysis to be surrendered. In addition, it is warned about the undesirable consequences that can have a reception of an experimental drug.

Participant at any time and without explaining the reasons may leave the study. Moreover, if a doctor considers that further participation in the tests is dangerous for the patient, the latter will be immediately excluded from the group.

During the test of medication, the patient has the right to constant free medical observation and qualified medical care.

In case of harm to the health of the patient, it has the right to material compensation in accordance with the size of insurance. By the way, participation in clinical trials is not rewarded financially, with the exception of the first phase of the test, when the drug is investigated on healthy volunteers.

International standards of clinical studies primarily provide for their security for participants. Whatever good goals have been pursued by science, the research doctor puts health and the patient's life to the chapter.