Description
Book SynopsisThe meaning of Clinical Trials for humans has recently changed significantly,
“evolved”, so to speak. In today’s environment, where ethical validity is much more
strictly controlled, this meaning is far beyond “human drug testing” and much closer
to the “therapeutic goal”. The number of clinical trials in western countries that have
perceived this change has increased rapidly and continues to increase. Although
the number of clinical studies in the MENA region is increasing day by day, it is still
far from its potential. Among the reasons for this are legal, technological, ethical,
epidemiological, educational and economic factors. This book presents both the
difficulties encountered in conducting clinical trials in MENA and suggestions for
solving these difficulties.
Table of Contents Fatih Özdener : General Picture of Clinical Research at MENA — Hamdi Akan : Clinical Trial Designs of the Future – Getting Ready at MENA — Nihan Burul Bozkurt, Gökhan Özkan : The Role of Regulatory Authorities and TITCK — İrfan Çiçin, Ali Gökyer : Role of Investigator — Peri Aytaç, Aydın Erenmemişoğlu : Early Phase Clinical Trials – Importance of Entry to MENA — Özgür Kasapçopur, Mehmet Yıldız, Fatih Özdener : Ethical Considerations (Clinical Research in Pediatric and Sensitive Populations) — Bilge Aydın Temiz : The Requirement and Importance of Legal Regulations in Drug Clinical Trials — Mutlu Hayran, Deniz Yüce : Importance of Epidemiological Data — Barış Erdoğan, Le Vin Chin : Clinical Research and Healthcare Digitalization in the Middle East and Turkey — Fatih Ozdener : Sponsoring Clinical Trials at MENA – Need for New Pharmacoeconomic Models — Fatih Özdener, Alihan Sürsal, Zülfiye Gül : Good Clinical Practice Training from the Perspective of Raising Clinical Trial Awareness .
