| Abstract [eng] |
The dissertation aims to analyse the problem of informed consent in clinical drug trials. Understanding of the provided information is one of the basic components of a person’s sound and informed decision to participate in a clinical trial. Our research evaluated informedness about clinical trials of patients participating in clinical drug trials in Lithuania, with emphasis on the informedness about key elements of clinical trial design (placebo-control, double-blindness, and randomisation). An anonymous survey of patients participating in clinical drug trials was conducted for the purposes of this study. The results of the study reveal that the legal framework sets the basis for adequate informedness about clinical trials of clinical trial participants, however, patients participating in placebo-controlled clinical trials are insufficiently informed about clinical trials. Patients participating in placebo-controlled clinical trials are better informed about the rights of clinical trial participants than about clinical trial design, however, informedness about design is a more important condition for overall informedness. The majority of placebo-controlled clinical trial participants do not understand at least one of the three key elements of clinical trials design and they tend to interpret the scientific methods used in clinical trials therapeutically. |
