Clinical Research at MENA

clinical research in a geography depends on factors ranging from researcher potential to infrastructure and regulatory authority to ethical approaches. This book takes a snapshot of the state of clinical research in the MENA region and aims to propose solutions to current challenges.

The 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.

Autorentext

Fatih Özdener graduated as a medical doctor from Hacettepe University Faculty of
Medicine in 1990 and practiced clinical medicine in Turkey for 5 years. He obtained
PhD in Pharmacology from Temple University in USA in 2000 and worked as a
postdoctoral researcher at the same university prior to joining academia.

Fatih Özdener has broad pharmaceutical industry experience at different local and
regional medical functions including clinical operations, clinical quality and medical
management in Turkey, Middle East and Africa. He has more than twenty publications
in the fields of molecular and clinical pharmacology.

Currently, he is a faculty member and a member of management board at Bahcesehir
University School of Medicine and the program coordinator of Pharmaceutical
Medicine master's degree program at the same university.

Inhalt

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 - Irfan Çiçin, Ali Gökyer : Role of Investigator - Peri Aytaç, Aydin Erenmemisoglu : Early Phase Clinical Trials - Importance of Entry to MENA - Özgür Kasapçopur, Mehmet Yildiz, Fatih Özdener : Ethical Considerations (Clinical Research in Pediatric and Sensitive Populations) - Bilge Aydin Temiz : The Requirement and Importance of Legal Regulations in Drug Clinical Trials - Mutlu Hayran, Deniz Yüce : Importance of Epidemiological Data - Baris Erdogan, 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 .