About the book
The use of placebo in clinical studies is a matter of everlasting debate. It can be argued that placebo-controlled trials could be seen as the most exact method of evaluating the safety and efficacy of new treatment options. Oppositely, quite a few authors have consistently argued that placebo-controlled studies are unethical if an already approved and effective therapy is available for the condition being of research interest. So, there are several accepted and many times used definitions of placebo. For example, a placebo can be seen as a substance that does not contain active ingredients and is made to be physically indistinguishable from the actual drug being studied; or a placebo can be defined as a control substance that is given to people taking part in a clinical trial; and finally, a placebo can be considered as a pill or liquid that looks like the new treatment but does not have any treatment value from active ingredients. Unfortunately, these definitions cannot be of practical use if some generally applicable algorithms for evaluating the ethics of placebo-controlled studies would be shaped and further applied. The questions of equipoise, research problem justification, methodological necessity, adequately presented and appreciated information through informed consent, inclusion of vulnerable populations, inconsistent regulatory recommendations, and, finally, the question of exposing participants to unacceptable risks, all remain significant issues in placebo-controlled designs.
Therefore, the aims of this book would be to summarize the existing knowledge, as well as arguments for and against the use of placebo in clinical studies, and to provide some pragmatic suggestions for developing and conducting placebo-controlled studies that can be ethically acceptable.