Clinical studies are a particular subtype of scientific experiments, the main purpose of which is to assess the safety and pharmacological activity (efficacy) of medicinal products for human use.
Clinical studies are the main stage in the development of a medicinal product, after successful completion of which you can proceed to the stage of marketing authorization. It is impossible to carry out registration and obtain permission to administer this drug in humans without such tests and their positive results. Therefore, clinical trials can be called the most important stage in the development of medicinal products.
Clinical laboratory tests
The term ‘clinical studies’ also includes bioequivalence studies. As a rule, they are carried out to confirm the bioequivalence of the generic drug to a similar original one.
The results of Clinical trials show
- whether the drug can be used to treat this disease;
- dosage regimen;
- if there are any constitutional peculiarities when it cannot be used;
- whether the product is safe, etc.
The main feature of clinical studies is the need to conduct experiments on humans. The reason for this is that the use of primates and / or any other animal models cannot fully demonstrate the body’s drug reaction.
All procedures and stages of clinical studies are carried out strictly in accordance with the clinical study protocol approved by the authorized body. Clinical studies should be carried out only in those healthcare institution that have special permission (accreditation) for this type of activity.
Clinical trials, basic requirements
The requirements for the organization and conducting of clinical trials established in the Republic of Belarus are set forth in the Technical code of practice (TKP) 184-2009 (02040). This standard is harmonized with the international document ICH E6 (Good Clinical Practice), which allows to apply the results of clinical trials conducted in the Republic of Belarus abroad.
An indispensable prerequisite for conducting clinical trials is the observance of the rights of study participants – volunteers or patients.
To guarantee these rights, the materials of the clinical trial are sent for approval to the Independent Ethics Committee (IEC), which correlates the benefits and risks of the test drug administration.
To conduct clinical trials it is necessary to obtain the approval of the IEC – this is a prerequisite.