Clinical Study

No drug can enter the market without completing the clinical-study stage. A clinical study is a large-scale scientific investigation conducted with mandatory human participation. Its purpose is to obtain reliable information on the safety and efficacy of a new drug, or to study new properties of an already known drug. Based on the data obtained in the study the competent health authority decides either to refuse registration or, conversely, to grant it. Without clinical studies the latter is simply impossible — they are mandatory.

At the very start of a clinical study a small number of volunteers and/or patients are involved (depending on the required results). As more safety and efficacy data become available the number of participants increases.

As a rule, the safety and efficacy of the investigational product are compared with those of the best available original drug for treating the specific condition. In Russia clinical studies are not yet as popular as in the US or Western Europe, but more and more Russian citizens are being invited to participate in clinical studies and are accepting those offers.

Why? The main reasons are:

1. The desire to help people. This is the main reason. A person is ready to expose themselves to a minimal but still existing risk in order to help others — help science find solutions to human-health problems, help people suffering from the same condition. After such a step the world becomes a little better.
2. The desire to receive the latest drugs for treating their own illnesses — absolutely free. Thanks to clinical studies, people suffering from certain illnesses can get cured while also helping others who will later be able to use the drug.
3. The desire to receive a complete, free health check. Before a person is admitted to participate in a clinical study, their health is always evaluated through a full medical examination performed by highly qualified medical staff.

It is very important to provide the potential participant with information about how the study is conducted, about possible risks and their likelihood, what to expect before, during and after the study — in short, the person must know everything that could affect their decision. There is even a specific concept — “informed participation,” i.e. a decision based on the key facts of the study.

You should also understand that not everyone is eligible for every study. You must meet the so-called selection criteria: sex, stage and type of an illness (or absence of one), age, medications being taken and so on. The two main tasks of the selection criteria are: first, to prevent participation by people for whom the study would be harmful; second, to ensure that the results obtained meet the study’s objectives.