The book, intended for biomedical researchers, attempts to foster a comprehensive understanding of the elements that impact scientific research, such as clinical trial design, communication, and publication methods. It introduces the process of idea generation and creative/critical thinking, leading to the development of key concepts that coalesce into theoretical constructs and working hypotheses. The book systematically delineates research phases associated with a bench-to-bedside translational approach, providing the full depth and breadth of drug discovery and development: design, synthesis, and optimization of drug candidates interacting with targets linked to diseases, as well as clinical trial design to acquire substantial evidence of efficacy and safety for candidate drugs in the target patient population. New and evolving topics such as artificial intelligence, machine and deep learning, drug repurposing approaches, and bioinformatics, are incorporated into the text as these features are becoming integrated into drug research and development. Additionally, it covers publication strategies, including literature search, manuscript preparation, data presentation, relevant discussion, editorial processes, elements of peer review, and bibliometrics. Finally, the book addresses grantsmanship, key strategies for building effective networks, mentorships, maintaining research integrity, and forging career advancement opportunities, including entrepreneurship.

This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

A practical guide to healthcare professionals involved in conducting clinical research. This book is designed to fill a void in clinical research education and to provide the necessary fundamentals for clinical investigators, physicians, Ph.D. basic scientists, as well as students and those actively participating in clinical research.

This expanded third edition provides an introduction to the conduct of clinical research as well as more comprehensive and expansive content about the infrastructure necessary for a successful clinical research organization or enterprise. With authors who are experts in clinical research in both the public and private sectors, this publication provides essential information to clinical investigators who wish to develop and conduct well designed patient-based research protocols that comply with rigorous study design, ethical, and regulatory requirements.

This book aims to make the readers better informed and more critical consumers of clinical research. It will help the reader recognize the strengths and the weaknesses of scientific publications. In doing so, the reader will be able to distinguish patient-important and methodologically sound studies from those having limitations in design, conduct and interpretation. The text is basic and has no statistical formulas. Key take-home messages are listed at the end of each chapter. Cartoons make the text easier to read and generate a few laughs, and they underscore specific points, sometimes in a provocative way.

Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This product incorporates current research methodology--including molecular and genetic clinical research--and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing.