Clinical Research at MENA

Challenges and Solutions

by Fatih Özdener (Volume editor)
©2022 Edited Collection 142 Pages


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.

Table Of Contents

  • Cover
  • Title
  • Copyright
  • About the editor
  • About the book
  • This eBook can be cited
  • Table of Contents
  • List of Contributors
  • General Picture of Clinical Research at MENA (Fatih Özdener)
  • Clinical Trial Designs of the Future – Getting Ready at MENA (Hamdi Akan)
  • The Role of Regulatory Authorities and TITCK (Nihan Burul Bozkurt, Gökhan Özkan)
  • Role of Investigator (İrfan Çiçin, Ali Gökyer)
  • Early Phase Clinical Trials – Importance of Entry to MENA (Peri Aytaç, Aydın Erenmemişoğlu)
  • Ethical Considerations (Clinical Research in Pediatric and Sensitive Populations) (Özgür Kasapçopur, Mehmet Yıldız, Fatih Özdener)
  • The Requirement and Importance of Legal Regulations in Drug Clinical Trials (Bilge Aydın Temiz)
  • Importance of Epidemiological Data (Mutlu Hayran, Deniz Yüce)
  • Clinical Research and Healthcare Digitalization in the Middle East and Turkey (Barış Erdoğan, Le Vin Chin)
  • Sponsoring Clinical Trials at MENA – Need for New Pharmacoeconomic Models (Fatih Ozdener)
  • Good Clinical Practice Training from the Perspective of Raising Clinical Trial Awareness (Fatih Özdener, Alihan Sürsal, Zülfiye Gül)

List of Contributors

Ali Gokyer, MD

Medical Oncology, Trakya University, Medical School, Edirne, Turkey

Alihan Sürsal, MSc

Farmakon Research Development Training and Consultancy, Istanbul, Turkey

Aydın Erenmemişoğlu, MD

Professor of Pharmacology, Farmagen R&D Biot. Ltd, Gaziantep, Turkey

Barış Erdoğan, PhD

CEO, Clinerion Ltd, Basel, Switzerland

Bilge Aydın Temiz-LL.M

Vona Law Firm, Partner, Att.at Law & Mediator

Deniz Yüce, MD, PhD

Epidemiologist, Hacettepe University Cancer Institute, Ankara, Turkey

Fatih Özdener, MD, PhD

Associate Professor of Medical Pharmacology, Bahçeşehir University School of Medicine, Istanbul, Turkey

Gökhan Özkan M.Sc.

Clinical Trials Department, Turkish Medicines and Medical Devices Agency, Ankara, Turkey

Hamdi Akan, MD

Retired Professor of Hematology,

Head, Clinical Research Association, Turkey

İrfan Çiçin, MD

Professor of Medical Oncology, Trakya University, Medical School, Edirne, Turkey

Mehmet Yıldız

Assistant Professor of Pediatric Rheumatology, Istanbul University- Cerrahpasa, Cerrahpasa Medical School, Istanbul, Turkey

←7 | 8→

Mutlu Hayran, MD, PhD

Professor of Epidemiology, Hacettepe University Cancer Institute, Ankara, Turkey

Nihan Burul Bozkurt, PhD

Head of Clinical Trials Department, Turkish Medicines and Medical Devices Agency, Ankara, Turkey

Ozgur Kasapcopur, MD

Professor of Pediatric Rheumatology, Istanbul University-Cerrahpasa, Cerrahpasa Medical School, Istanbul, Turkey

Peri Aytaç, Pharm. PhD

Novagenix Bioanalytical Drug R&D Center, Ankara, Turkey

Le Vin Chin

Head of Marketing & Communications, Clinerion Ltd, Basel, Switzerland

Zulfiye Gul, Pharm. PhD

Assistant Professor of Medical Pharmacology, Bahçeşehir University School of Medicine, Istanbul, Turkey

Fatih Özdener

General Picture of Clinical Research at MENA

Drug development processes are long and costly processes. The development of a drug can cost up to a billion dollars, and the whole process can take 10–15 years. The process of drug development involves in-silico and in-vitro trials, as well as animal testing. The most costly and long-lasting period of the development process is undoubtedly the clinical trials. Clinical trials often include phase studies ranging from a small group of healthy people to internationally organized multicenter trials on patients. In phase studies, the safety and the effectiveness of the drug are tested at every stage, starting with the healthy group and continuing with the patient group. Research products that successfully pass these phase studies begin to be prescribed by obtaining a license. Following the license obtainment, the safety of the drug continues to be monitored through safety notices during the routine postauthorization prescription.

The conductance of clinical trials is subject to a certain quality standard, called the Good Clinical Practices (GCP). Despite the application of these standards in the vast majority of countries where the clinical research is conducted, some countries are still in the adaptation phase with respect to these rules. The standard of quality ensures the quality of the most critical stages of clinical trials such as planning, execution, reporting, archiving, and most importantly, protecting the health and the well-being of the subjects participating in the clinical trial.

Historically, clinical studies have been conducted largely by the economically developed countries as a result of the aforementioned cost and time factors for the required studies, and the compulsory Good Clinical Practice standards. While there is an intense activity of clinical studies observed in some parts of the world, this activity is observably very low compared to the respective population in some other regions.

In this introductory section, the globally conducted clinical trials (CTs) are analyzed, and the number of these conducted clinical studies and their respective ratios to populations, types, and phases are evaluated. This evaluation was performed by scanning the ClinicalTrials.gov website in terms of the number of clinical studies performed in global regions, the number of pediatric CTs, the study type, the age group, the participation status of healthy volunteers, and the type of funding and fund providers. According to the results, it has been observed that most of the CTs have been conducted in North America and Europe (71 %), ←9 | 10→while the remaining minority (29 %) have been carried out in the rest of the world. The Middle East (ME) region, including Turkey, accounts for only the 4.5 % of all trials and ranks 4th after East Asia (11.5 %). The countries with the lowest number of CTs in the world include North Africa (1.6 %), other regions of Africa (1.5 %), and Central America (0.9 %) (Table 1 and Figure 1a).

Table 1: Distribution of CTs, CT phases, and pediatric CTs among the global regions


Total CTs, (%)

Early Phase 1 CTs, (%)

Phase 1 CTs, (%)

Phase 2 CTs, (%)

Phase 3 CTs, (%)

Phase 4 CTs, (%)

Pediatric CTs, (%)


CT Ratio ‱


1 (<0.1)






1 (100.0)



East, Central, West and South Africa

5587 (1.5)

17 (<0.1)

363 (6.5)

1024 (18.3)

1758 (31.5)

469 (8.4)

2456 (44.0)



North Africa

5629 (1.6)

77 (1.4)

215 (3.9)

701 (12.5)

853 (15.2)

614 (10.9)

1584 (28.1)


Biographical notes

Fatih Özdener (Volume editor)

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.


Title: Clinical Research at MENA
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144 pages