A Comprehensive Guide for the Novice Researcher in Clinical Trials

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.

• 1. Introduction to Health Research Methods2. History of Clinical Trials3. Clinical Trial Designs4. Clinical Trial Essentials5. Ethics and Good Clinical Practice in Clinical Trials6. Trial Protocol Development7. Clinical Research Site Operation8. Clinical Data Management9. Clinical Trial Monitoring10. Principles of Statistics in Clinical Trials11. Reporting Clinical Trials12. Essentials of Project Management13. Regulatory Affairs of Clinical Trial in Saudi Arabia14. Training Programs and Job Opportunity in Clinical Trial Industry

Select Guide Rating