Who can participate in clinical trials?
To participate in a clinical trial is allowed for a person who suffers from a specific disease and meets specific inclusion criteria. These criteria are set out in the Clinical Trial Protocol. An investigator, who is conducting a clinical trial and recruiting patients for it, determines whether a patient meets the criteria. The correctness of the final assessment of the investigated drug’s effectiveness depends on the proper selection of the group of patients to be included in the clinical study.
Some of clinical trials take place with the participation of patients with a given disease, while in others only healthy volunteers are sought after.
Before deciding to enter a clinical trial the patient should get as much information about the study as possible so that she/he is able to make a deliberate, conscious decision, taking into account all potential risks. A physician conducting the clinical trial should provide the patient with any information and dispel her/his possible doubts. In special cases, minors may also participate in a clinical trial. Their participation in clinical trials is governed by the Ordinance of the Minister of Health from the 30th of April, 2004 on the way of conducting clinical trials involving minors.
It is important to know that each person participating in the clinical trial has legal rights to ensure her/his safety. It is worth knowing them and using them.