Applied Clinical Trials
John I. Gallin, Ed. (Academic Press, San Diego, CA, 2002), 490 pages, hardcover, ISBN: 0122740653, $99.95.
Principles and Practice of Clinical Research
John I. Gallin, Ed. (Academic Press, San Diego, CA, 2002), 490 pages, hardcover, ISBN: 0122740653, $99.95.
A quotation from its preface offers the best description of this booka product of an introductory course of the same title first offered at the NIH Clinical Center in Bethesda in 1996. More than 40 scientists, most from the National Institutes of Health, contributed to it. Topics covered include ethical, regulatory, and legal issues; integrity in research; IRBs; data management; clinical trial design; technology transfer; getting funding; and navigating the NIH peer review process.
The book can be considered valuable for those who are involved in clinical research at the NIH and affiliated academic institutions. It can help the reader to understand the clinical research paradigm at the NIH.
As expected from a book based on a teaching course, some of the chapters overlap considerably (for example, those on clinical trial design) and are based on the interests of the authors rather than compiled as a systematic course in clinical research. In addition, data in a number of chapters have not been updated. In many cases, the book uses references dated before 2000. The book also cites examples of clinical research tools and roles of clinical research staff that seem at odds with those currently used in clinical drug development. Results of recent discussions on conflict of interest (particularly financial) by investigators, potential conflicts between clinical research and clinical practice, and the trend toward including special populations (such as pediatric subjects) are not presented.
Readers interested in clinical drug development will be disappointed. The chapter on The Regulation of Drugs and Biological Products by the Food and Drug Administration is very general and one of the shortest in this book (only 10 pages). The standard description of clinical trials used by the FDA and the pharmaceutical industry (as Phases 14) is mentioned only in one table. Instead the book includes chapters on Design and Conduct of Observational Studies and Clinical Trials, Small Clinical Trials, and Large Clinical Trials: Clinical Research Institutes.
The book would have been of considerable interest to the readers of Applied Clinical Trials if it had been structured as a systematic approach to clinical drug development, included broader references to FDA regulations, and bridged the differences between principles and practices of clinical research at the NIH with those currently used in clinical drug development.
Insofar as this book can be considered the golden standard for clinical research at the NIH and related academic institutions, it may further explain the continued decline in the number of industry-sponsored studies con-ducted at academic institutions.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Making the Grade: Registries as Sources of Regulatory-Grade Real-World Evidence (RWE)
February 13th 2025Dr. Peter Wahl, MLA, MS, ScD, VP and Global Head of Scientific Affairs at CorEvitas, part of the PPD™ clinical research business of Thermo Fisher Scientific, discusses the critical role of protocol-driven registries in generating regulatory grade RWE to serve multiple and evolving evidence needs across the drug development life cycle. He covers key considerations for selecting the right type of registry, the advantages over EMR datasets, and how registry data contextualizes safety and effectiveness to fulfill FDA and EMA post-marketing requirements.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
SCOPE Summit 2025: Enhancing the Patient Experience Through Site Centricity
February 12th 2025In an interview with ACT senior editor Andy Studna at SCOPE Summit, Ashley Davidson, vice president, product lead - sponsor tech strategy, Advarra, highlights the need for more site-centric approaches in study startup.