By Hadi Danawi, Ph.D., chair and president, Arab Board for Clinical Research
This article is part three of a three-part series on Arab participation in clinical research. Parts one and two can be read here and here.
Looking beyond the imperative of involving more Arab Americans in clinical trials, there’s more to be said about involving the Middle East and North Africa (MENA) region itself in clinical research. The MENA region is home to 22 Arab countries: Algeria, Bahrain, Comoros, Djibouti, Egypt, Iraq, Jordan, Kuwait, Lebanon, Libya, Mauritania, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Somalia, Sudan, Syria, Tunisia, United Arab Emirates, and Yemen. Combined, they are home to a diverse population, which provides an opportunity to study various diseases and conditions across different genetic, ethnic, and cultural backgrounds. Specifically, the region faces a significant burden of diseases, including non-communicable diseases (such as diabetes, cardiovascular diseases, and cancer) as well as infectious diseases (such as hepatitis and respiratory infections). Conducting clinical research in the MENA region can help address specific healthcare challenges and contribute to the development of targeted interventions and treatments.
Challenges To Conducting Clinical Research In MENA
Despite the potential, the MENA region has been relatively underrepresented in clinical research compared to other regions. There is scarcity of data relating to clinical research in the MENA region, but researchers Nair (2013) and Mohamed (2021) stressed the need to scale clinical trials in MENA as it is estimated to sponsor less than 1% of all global clinical trials. And, according to clinicaltrials.gov, there are no records found for studies being conducted in the Middle East and only 72 records registered in Egypt, North Africa. To illustrate the imbalance of clinical research around the world, we need only look at the WHO’s International Clinical Trial Registry Platform (ICTRP). According to WHO, the United States, Middle East, and entire continent of Africa listed 168,520, 4,593, and 861 trials, respectively, in 2022. Most of these trials registered within MENA remain inactive.
Several factors for infrequent research in MENA include regulatory challenges, lack of awareness, language barriers, socioeconomic constraints, and limited collaboration between academic institutions, healthcare providers, and pharmaceutical companies. In some areas of the MENA region, there may be limited access to advanced healthcare facilities, research centers, and specialized medical equipment. These can all hinder the introduction of large-scale clinical trials and may discourage researchers from pursuing studies in the region.
Variability in regulatory frameworks across different countries within the MENA region can be challenging for conducting multinational clinical trials. Delays in obtaining approvals and navigating complex regulatory processes may deter pharmaceutical companies and researchers from choosing the region as a study site. These delays stem from the non-unified regulatory systems in the MENA region. For instance, according to Saudi Vision 2030, the Kingdom of Saudi Arabia is currently planning to undergo a benchmarking project to initiate the Saudi NIH standards for scientific and clinical research, while Egypt adopted the ICH GCP guidelines in 2006 and implemented a framework to regulate clinical research in 2020. The United Arab Emirates issued its Department of Health guidelines for conducting clinical trials with investigational products and medical devices in 2020. In addition, Qatar recently increased its global footprint in clinical trials, especially post Covid, with 251 clinical trials listed on the ICTRP in 2022. Considering the rapidly growing economic and healthcare systems in Qatar, the country is still witnessing relatively slow progress in clinical research.
Limited awareness and understanding of the importance and benefits of clinical research among the general population and healthcare professionals can contribute to low participation rates in clinical trials. Clinical awareness is not embedded in the culture, with less importance being placed on campaigns and advertisements than in the western world. This lack of awareness may lead to misconceptions and hesitation about participating in research studies. Insufficient collaboration and communication between academic institutions, healthcare providers, and pharmaceutical companies in the region can hinder the development and execution of clinical research projects that would otherwise bring together diverse expertise and resources.
Language barriers, particularly in regions where Arabic is the primary language, can be a challenge in clinical research. Translating study materials and ensuring effective communication with participants for the successful implementation of trials may be difficult to realize. There will be a need to translate various publications into Arabic and adapt or modify them to address the differences among the various countries in the MENA region. These publications include the Belmont Report; World Medical Association, Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects; Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects; and the U.S. Health and Human Services Regulations for the Protection of Human Subjects.
Socioeconomic disparities in the region may affect access to healthcare and willingness to participate in clinical research. Economic constraints and a lack of healthcare coverage may limit the pool of potential participants in clinical trials, particularly in regions facing economic crises and political instability, like Lebanon, Syria, Iraq, Sudan, and Yemen.
To address these challenges in developing robust clinical research, industry as well as the governments of these 22 countries should consider innovative and other strategies to streamline regulatory processes; encourage relationships among industry, academia, and healthcare providers; and drive investment in research infrastructure, including research centers, clinical trial sites, and laboratories. Sponsors might consider raising awareness about the significance of clinical research and its potential advantages among healthcare professionals, researchers, and the general population. Educational programs, workshops, and conferences can also play a pivotal role in disseminating knowledge and nurturing a research-oriented culture in MENA.
Despite Challenges, Sponsors Should Still Expand To MENA
Still, sponsors ought to consider conducting clinical trials in the MENA region because in addition to its diverse patient population as well as its high disease burden, the region is witnessing a rapidly growing healthcare market in some countries, especially oil-rich countries, as well as increasingly health literate and enthusiastic participants, a regional willingness to undergo regulatory improvements, and, most importantly, a cost-reduced environment. It is worth noting that there is an economic gap in MENA between countries with limited resources and oil-rich countries, with differences pushing resource limited countries to significantly fall behind.
In addition to the above, the healthcare market in some areas of MENA is expanding rapidly, with increasing investments in medical facilities and technologies. This can be noted in the oil-rich countries of the Persian Gulf, including Saudi Arabia. Sponsors can gain early access to emerging markets in MENA, positioning themselves advantageously as the healthcare landscape continues to evolve and grow. This growth signifies a potential increase in the availability of qualified investigators and research centers in the future. The Gulf Region is attracting healthcare professionals expressing a keen interest in participating in clinical trials to access cutting-edge treatments and contribute to advancing medical knowledge.
Some countries in MENA have made strides in improving their regulatory processes for clinical trials, as discussed before. Regulatory authorities are working to streamline approval timelines and align with international standards, making the region more attractive for sponsors. Conducting clinical trials in MENA can often be more cost-effective than in some other regions. Lower operational costs, access to a diverse patient population, and potential recruitment advantages contribute to this cost-effectiveness.
Although efforts regarding clinical research in MENA have been somewhat limited and hesitant, there are notable initiatives making strides. For instance, the American University of Beirut Medical Center in Lebanon is actively seeking to attract sponsors for research endeavors. Additionally, Hamad Medical Corporation in Qatar is diligently working toward establishing its clinical research agenda. In Egypt, a country with a population of over 100 million, a group of dedicated healthcare professionals is actively prioritizing a clinical research agenda in Qena governate, upper Egypt.
Fostering greater awareness of and support for clinical research in the MENA region can unlock its vast potential and contribute significantly to advancing medical knowledge, improving healthcare outcomes, and addressing the specific healthcare needs of its diverse population.
Creating and establishing regional networks or consortiums involving multiple countries in MENA can enhance collaboration, share resources, and facilitate multi-center clinical trials. Such networks can help overcome individual country limitations and increase the sample size and diversity of study populations.
The MENA region can create an environment conducive to clinical research, attract pharmaceutical companies, and significantly contribute to the generation of scientific evidence that benefits both the local population and the broader medical community. Collaboration between stakeholders, government support, and sustained efforts are essential to realize the full potential of clinical research in the region.
Mohamed, A.S, Cosme Villar, R.C, & Nashwan, A.J. (2021). Clinical Trials History & Trends in Qatar. Journal of Emergency Medicine, Trauma and Acute Care, Vol 2021-Abs 34. DOI: 10.5339/jemtac.2021.qhc.34
Nair, S. C., Ibrahim, H., & Celentano, D. D. (2013). Clinical trials in the Middle East and North Africa (MENA) Region: grandstanding or grandeur?. Contemporary clinical trials, 36(2), 704–710. https://doi.org/10.1016/j.cct.2013.05.009
About The Author:
Hadi Danawi, Ph.D., is a professor in global public health and epidemiology. He is actively engaged in industrywide projects relating to remote consulting, higher education (master and doctoral programs in public health/healthcare administration), and clinical trial design and management. Danawi created the Arab Board for Clinical Research to promote diversity and inclusion of Arabs and Arab Americans in clinical research, the use of DCTs, and education and staffing of Arabs and Arab Americans in clinical research.
Danawi has expertise with pharmaco-epidemiology and drug safety/pharmacovigilance with Big Pharma, including outcomes research and RWE. He is passionate about creating positive social change in underserved communities in Africa and the Middle East and so established a not-for-profit organization with chapters in Lebanon and Ghana to provide technical assistance for project implementation, curriculum development, and training of local associates for self-reliance in disease prevention, health services, and family and community health initiatives.