A Comprehensive Guide for Novice Researcher in Clinical Trials

A Comprehensive Guide for Novice Researcher in Clinical Trials is a must-have resource for individuals embarking on the journey of clinical research. This book is tailored for beginners, offering a clear and structured introduction to the vital principles, methodologies, and skills required to design and conduct robust clinical trials. Spanning 13 chapters, it meticulously covers the entire clinical trial process, emphasizing Good Clinical Practice (GCP) standards. From foundational research concepts to advanced trial strategies, the guide empowers readers to confidently navigate the complexities of clinical trials and contribute meaningfully to the field of healthcare.

In addition to its foundational content, the book addresses a variety of important topics, such as ethical considerations, regulatory compliance, and the development of trial protocols. It explores different trial designs, types of bias, and the historical evolution of clinical research. Practical sections on data management, monitoring, statistical analysis, and project management offer readers hands-on guidance for real-world application. Notably, the book includes a dedicated focus on regulatory affairs in Saudi Arabia, making it particularly valuable for health professionals in that region.

• Includes content that follows a stepwise format, making it easy for novice researchers to absorb complex conception
• Focuses on the ethical considerations and GCP standards essential for conducting clinical trials
• Provides detailed insights into the responsibilities of researchers, informed consent processes, and strategies for maintaining participant safety and data integrity
• Includes practical tools and templates for protocol development, data management, and trial monitoring

Miltiadis D. Lytras is a Professor of Artificial Intelligence, Digital Transformation, and Knowledge Management at Effat University (Saudi Arabia) and The American College of Greece. He is an internationally recognized researcher with extensive experience in AI, data science, smart systems, and digital innovation across healthcare, education, government, and business. He has served as Principal Investigator and Senior Researcher in numerous international and national research projects and has published more than 100 peer-reviewed articles and over 40 books with leading international publishers. His work focuses on responsible and human-centered AI, advanced decision-making systems, and the strategic impact of emerging technologies on organizations and society.

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 Profession 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.

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.