Clinical trials in the Middle East and North Africa (MENA) Region: Grandstanding or Grandeur?
Introduction
The pharmaceutical industry is a leading global industry, exploiting recent revolutions in technological advances and taking advantage of trends in globalization to enhance its assets and thereby influencing global healthcare. Clinical trials are required to test the safety and efficacy of new drugs or devices to lessen the burden of common diseases such as cancer and diabetes. In the past quarter of a century, the pharmaceutical industry witnessed unparalleled growth in developed countries with sales performance outpacing GDP growth. In the 1990's less than 15% of clinical trials were conducted outside of the United States [1]. Recent reports indicate that nearly a third (31%) of the world's clinical trials are currently being conducted outside of the US and one-quarter of investigational new drug (IND) applications include data from clinical trials conducted at international study sites [2]. Many of these clinical trials are conducted in low- and middle-income countries such as India, China, Egypt, the emerging economies of Central and Eastern Europe (CEE) and the Commonwealth of Independent States (CIS) [3]. In addition to regulatory reasons for the conduct of clinical trials in these diverse countries, strategic and economic factors have also stimulated the globalization of trials. The need for diverse patient populations for research, decreased trial costs, improved subject accrual, and access to rare diseases is an additional driving force for the expansion of international clinical research. The clear beneficiaries of the recent wave of globalization of clinical trials have been the CEE and the CIS countries. The CEE and CIS combined provided 10.74% of the total global clinical trial sites, ahead of both Latin America (4.6%) and Asia — excluding Japan (4.5%) [4].
The Middle East/Northern Africa (MENA) region covers a surface of nearly fifteen million square kilometers from Morocco to Iran and includes the six Gulf Cooperation Council (GCC) countries. The GCC is a political and economic union of six Arab states bordering the Persian Gulf (United Arab Emirates, Bahrain, Qatar, Kuwait, Oman and Saudi Arabia). The MENA region accounts for 385 million people or 6% of the world's population [5], [6] and is growing at an average annual rate of 1.8% compared to the global population average growth of 1.2% [7]. Demand for medications in the region has surged because of high population growth, improved life expectancy, lower mortality rates and the increased prevalence of life-style related diseases, all associated with rapid economic development [4], [5]. Yet, the optimism projected by pharmaceutical business forecasts has not been translated into a significant increase in trial participation in the MENA region, especially when compared to other emerging markets such as India, China, Russia and Mexico (Table 1). This review identifies the various challenges and opportunities for the expansion of clinical trials in the MENA region.
Section snippets
Regulatory firewall
One of the challenges in conducting clinical trials in countries new to research opportunities is the diligent need to monitor and adhere to many regulatory changes. Clinical Research Organizations (CROs) and trial sponsors need to constantly monitor regulatory change to avoid delays or disruptions in on-going trials. Drug importation procedures required for new investigational drugs vary among the MENA countries [5]. Legal rights to experimental drugs can also vary from region to region. The
Disease pool
Genetic and cultural differences within the local populations of the MENA offer unique opportunities for medical research. The different ethnicities, the high rate of consanguineous marriages and the geographic isolation of subpopulations making up the region all contribute to the distinct gene pool of the MENA region [15]. Community studies from Western countries show that approximately 3% of all pregnancies result in the birth of a child with a significant genetic disease that manifests as
Conclusion
The unprecedented sales performance in mature economies of the world limited the pharmaceutical industry's ability to explore opportunities in regions such as Asia, Latin America and the MENA region. Globalization of clinical research ensures involvement of diverse patient populations and improved subject recruitment numbers and pace, both critical to hasten development and approval of new drugs, especially those that are life-saving, and make them available world-wide. Issues with legal rights
Abbreviations
- CEE
Central and Eastern Europe
- CIS
Commonwealth of Independent States
- CROs
Clinical Research Organizations
- CVD
Cardio Vascular Diseases
- GCC
Gulf Cooperation Council
- GDP
Gross Domestic Product
- IND
Investigational New Drug
- SOP
Standard Operating Procedures
Submission declaration
The authors declare that this manuscript has not been previously published and is not under consideration for publication elsewhere and, further that it is approved by all authors.
Acknowledgments
The authors wish to thank Dr. Ronald Krall, Steamboats Spring, Colorado, USA for reading a draft of the manuscript. SCN was awarded “Leadership in Global Clinical Research Awareness 2012” by the ACRP (USA) and GCC, the outstanding chapter outside the US. The study was granted ethics approval by the Al Ain Medical District Human Research Ethics Committee (AAMDHREC) #12/55. MindSmart UAE is acknowledged for technical assistance with the manuscript. This study was not supported by grants/funds
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