Open access peer-reviewed Edited Volume

Placebo-Controlled Studies

Miroslav Radenkovic

University of Belgrade

Full-time professor of Pharmacology, Clinical Pharmacology and Toxicology (Faculty of Medicine, University of Belgrade - MFUB). Former Chairman of the Department of Pharmacology, Clinical Pharmacology and Toxicology (MFUB) and a former Member of the Ethics Committee (MFUB). Dr. Radenkovic is currently a member of the Ethics Committee of Serbia.

Covering

Physiological Processes Psychological/Social Harm Phase II Studies Phase III Studies Vulnerable Participants Methodological Quality Informed Consent Clinical Study Rationale National Protection Regulations Institutional Review Boards Pharmaceutical Companies Good Clinical Practice

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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.

Publishing process

Book initiated and editor appointed

Date completed: October 29th 2021

Applications to edit the book are assessed and a suitable editor is selected, at which point the process begins.

Chapter proposals submitted and reviewed

Deadline for chapter proposals: December 24th 2021

Potential authors submit chapter proposals ready for review by the academic editor and our publishing review team.

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Approved chapters written in full and submitted

Deadline for full chapters: February 22nd 2022

Once approved by the academic editor and publishing review team, chapters are written and submitted according to pre-agreed parameters

Full chapters peer reviewed

Review results due: May 13th 2022

Full chapter manuscripts are screened for plagiarism and undergo a Main Editor Peer Review. Results are sent to authors within 30 days of submission, with suggestions for rounds of revisions.

Book compiled, published and promoted

Expected publication date: July 12th 2022

All chapters are copy-checked and typesetted before being published. IntechOpen regularly submits its books to major databases for evaluation and coverage, including the Clarivate Analytics Book Citation Index in the Web of ScienceTM Core Collection. Other discipline-specific databases are also targeted, such as Web of Science's BIOSIS Previews.

About the editor

Miroslav Radenkovic

University of Belgrade

Miroslav Radenković, MD, graduated from the Faculty of Medicine – University of Belgrade in 1995, and since 1996 he is working in the Department of Pharmacology, Clinical Pharmacology and Toxicology (Faculty of Medicine – University of Belgrade, Serbia), currently in the position of full-time professor. He received an MSc, board certified in Clinical Pharmacology, PhD, and sub-specialization in Clinical Pharmacology - Pharmacotherapy in 1999, 2000, 2004, and 2016 respectively, from the Faculty of Medicine – University of Belgrade. Recently, Dr. Radenković finished the Bioethics Masters Program at the Clarkson University, USA. Since 2002, Dr. Radenković officially has participated in research activities of several scientific projects supported by the Ministry of Science – Serbia, and currently he is an official participant of the NIH Fogarty International Center Project with the main aim of establishing a bioethics masters program at the Faculty of Medicine, University of Belgrade. In 2007 he was a senior postdoc and principal investigator of the scientific project financed by the Austrian Science Fund at the Medical University of Vienna, Austria. In 2011 Dr. Radenković acted as a book editor related to gestational diabetes (published by IntechOpen), and in 2021 Dr. Radenković acted as a book editor related to bioethics (published by Trivent Publishing).

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