The Fundamentals of Clinical Research - P. Michael Dubinsky

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PA, USA

       Karen A. Henry

       University of California, Berkeley

       Richmond, CA, USA

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      The right of P. Michael Dubinsky and Karen A. Henry to be identified as the authors of this work has been asserted in accordance with law.

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       Library of Congress Cataloging‐in‐Publication Data

      Names: Dubinsky, P. Michael, author. | Henry, Karen A., author.

      Title: The fundamentals of clinical research : a universal guide for implementing good clinical practice / P. Michael Dubinsky, Spartansburg, PA, USA, Karen A. Henry, University of California, Berkeley Richmond, CA, USA.

      Description: Hoboken, NJ : Wiley, 2022. | Includes index.

      Identifiers: LCCN 2021033034 (print) | LCCN 2021033035 (ebook) | ISBN 9781118949597 (hardback) | ISBN 9781118949603 (adobe pdf) | ISBN 9781118949610 (epub)

      Subjects: LCSH: Medicine–Research.

      Classification: LCC R850 .D83 2021 (print) | LCC R850 (ebook) | DDC 610.72–dc23

      LC record available at https://lccn.loc.gov/2021033034 LC ebook record available at https://lccn.loc.gov/2021033035

      Cover Design: Wiley

      Cover Image: © Mira N. Henry

      Goal

      Since 1996 the emergence of the good clinical practice (GCP) framework for the conduct of clinical trials, more than any other requirement or guidance, has served as a singular reference point for performing trials in humans in conformance with ethical and regulatory expectations. Certainly GCP is mentioned and described in all clinical trial texts, manuscripts, papers, and presentations, and it has moved beyond the role of guidance and become law in a number of global regions and countries: the GCP guidance document developed and published by the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has been adopted into law in both the European Union (EU) and Canada, and the World Health Organization has developed a set of GCPs for its constituency. For medical device products, the ISO standard 14155 was revised in 2011 and now serves as the GCP reference point for device‐related clinical research. That step eliminated the need for clinical investigators studying medical devices to debate whether they should be following the ICH‐GCP that was targeted at pharmaceutical drug studies. As a result, GCP has become the universal language of trials that involve human subjects.

      GCP provides a framework for clinical trial professionals to work within and guidance in how to abide by their local, national, and/or regional regulatory requirements. In turn, regional and national regulatory authorities integrate GCP into their clinical trial regulations, adopt it to their existing regulations, or call their regulations GCP. The regulatory authorities have established requirements that govern the conduct of trials, and these requirements represent the baseline for compliance. That said, much of the interpretation of the requirements is left to the trial sponsor, investigator, and clinical teams.

      We have designed this text to be used as source material in educational settings such as university courses and as a training aid for the clinical research industry. Our goal is to provide a universal working reference for all of the players in clinical trials: an educational resource that integrates the fundamentals of clinical research for working individuals, clinical research students, or any curious person. By “working individual,” we mean everyone from the novice to the seasoned clinical research professional in academia, industry, or a regulatory environment. From a practical viewpoint, this text has been written to address the regulatory, scientific, administrative, business, and ethical considerations of clinical research trials within a GCP framework. It describes how to implement clinical research to meet research, regulatory, and ethical objectives, such that the process succeeds the first time and does not need to be repeated.

      Clinical research has reached global proportions. This text will not attempt to touch on each individual country, but rather will look at global regions and nations, such as the EU and the United States, which set the pace for the implementation of GCP worldwide. We have

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