A Comprehensive Guide for Novice Researcher in Clinical Trials

Erscheinungsjahr 2026
ISBN: 978-0-443-27743-6
Verlag: Elsevier Science

Buch, Englisch, 320 Seiten, Format (B × H): 191 mm x 235 mm, Gewicht: 450 g

A Comprehensive Guide for Novice Researcher in Clinical Trials serves as an essential resource for anyone looking to navigate the complex world of clinical trials. Designed specifically for novice research enthusiasts, this book provides a thorough introduction to the principles, training, and skills necessary for designing and conducting clinical trials. Spanning 13 detailed chapters, it covers the entire spectrum of clinical trial methodology while adhering to Good Clinical Practice (GCP) standards. The book begins with foundational concepts in health research methods and clinical epidemiology, laying the groundwork for understanding the significance and necessity of clinical trials in healthcare. It explores various research designs, types of bias, and the historical context that shaped modern clinical trial practices. In-depth discussions on clinical trial design, including parallel, crossover, and adaptive designs, equip readers with the knowledge to select the appropriate framework for their research. Essential sections on ethics, regulatory requirements, and protocol development ensure that researchers understand the critical responsibilities involved in conducting ethical and scientifically sound trials. The guide also delves into practical aspects such as clinical data management, monitoring, and statistical principles, empowering readers to manage data effectively and analyze results accurately. With insights into project management and regulatory affairs specific to clinical trials in Saudi Arabia, the book addresses local challenges and requirements, making it particularly relevant for health professionals in the region. By providing a stepwise approach to clinical trial conduction, this book aims to promote better access, understanding, and utilization of clinical trials within diverse health disciplines. With its comprehensive coverage and up-to-date information, Clinical Trials: A Comprehensive Guide for Novice Researchers not only equips readers with the necessary tools to enhance their research capabilities but also contributes to the overall improvement of healthcare delivery and patient outcomes globally.

Autoren/Hrsg.

Lytras, Miltiadis

Alsaywid, Basim

Alsaleh, Doaa

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Biomedizin, Medizinische Forschung, Klinische Studien

Inhaltsverzeichnis

1. Introduction to Health Research Methods
2. History of Clinical Trials
3. Clinical Trial Designs
4. Clinical Trial Essentials
5. Ethics and Good Clinical Practice in Clinical Trials
6. Trial Protocol Development
7. Clinical Research Site Operation
8. Clinical Data Management
9. Clinical Trial Monitoring
10. Principles of Statistics in Clinical Trials
11. Reporting Clinical Trials
12. Essentials of Project Management
13. Regulatory Affairs of Clinical Trial in Saudi Arabia
14. Training Programs and Job Opportunity in Clinical Trial Industry

Über Autor(innen)

Alsaleh, Doaa
Dr. Doaa Alsaleh, MD, PhD, MSCR, is a physician-scientist with over a decade of experience specializing in clinical trials and real-world evidence (RWE) outcomes research. She completed a clinical research fellowship at Weill Cornell Medicine, followed by a Master's and PhD in Clinical Research from the Icahn School of Medicine at Mount Sinai.

Dr. Alsaleh has led and designed national training programs in clinical trials and public health research in collaboration with the Saudi National Institute of Health and the Public Health Authority. Her expertise includes methodology, data analytics, and predictive modeling.

She has published in peer-reviewed journals and presented internationally, including at the American Association for Thoracic Surgery (AATS) on CABG outcomes in diabetes. She received a research grant from Weill Cornell to lead a pilot clinical trial.

Dr. Alsaleh currently serves as Section Head of the Scientific Review Unit and Associate Research Scientist at KAIMRC, supporting Saudi Arabia's Vision 2030 through leadership in clinical research.

Lytras, Miltiadis
Miltiadis D. Lytras is an expert in advanced computer science and management, editor, lecturer, and research consultant, with extensive experience in academia and the business sector in Europe and Asia. Dr. Lytras is a Research Professor at Deree College - The American College of Greece and a Distinguished Scientist at the King Abdulaziz University, Jeddah, Kingdom of Saudi Arabia. Dr. Lytras is a world-class expert in the fields of cognitive computing, information systems, technology enabled innovation, social networks, computers in human behavior, and knowledge management. In his work, Dr. Lytras seeks to bring together and exploit synergies among scholars and experts committed to enhancing the quality of education for all.

Alsaywid, Basim
Basim Alsaywid, Pediatric Urology Surgeon, graduated from King Abdulaziz University then completed Saudi Board of Urology in 2007. He obtained his Pediatric Urology Training Certificate from a fellowship at Westmead Children Hospital and then Sydney Children Hospital at Randwick, Sydney, Australia. During his fellowship training, he completed his Master of Medicine degree from the University of Sydney in Clinical Epide?miology with focus on biostatistics, and then he completed his Master's in Health Profes?sion Education from King Saud Bin Abdulaziz University for Health Sciences, Saudi Arabia. Dr. Alsaywid founded the research offices at the College of Medicine and College of Applied Health Sciences at King Saud Bin Abdulaziz University for Health Sciences in Jeddah. Also, he founded and chaired the Research and Development Department at Saudi Commission for Health Specialties in Riyadh. Currently, Dr. Alsaywid is the Director of Education and Research Skills at Saudi National Institute of Health, Riyadh, Saudi Arabia.