Real World Evidence in the Middle East and North Africa (MENA) region.
by Jesica Levingston Mac Leod
The high incidence of rare diseases in the Middle East and North Africa (MENA) region is only one of the reasons why companies are looking into this area to expand their portfolios. The area includes the following countries: Algeria, Bahrain, Djibouti, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Malta, Morocco, Oman, Qatar, Saudi Arabia, Syria, Tunisia, United Arab Emirates, West Bank and Gaza, and Yemen. Ethiopia and Sudan are sometimes included, to account for a total population of over 400 million people.
Some interesting characteristics of the region are the share languages, religions and activities across borders. For example, the shared Arabic language and some holidays, such as Ramadan, might offer a similar management across countries, which facilitates the generation of RWE.
As presented in a recent webinar about the potential of this area:
"The MENA region presents unique challenges in data collection and research. Traditional methods in a clinical setting may not be feasible; instead, the region offers an extraordinary opportunity for the collection of real-world data, which not only acts to enhance existing data sets but may also accelerate product development."
The main key point that need to be addressed before actively investing in RWE in the area are the site selection, the Patient identification, recruitment and retention, the Logistical and cultural issues, including religion, language and regulatory climate, the Data sources, such as national registries, electronic medical records (EMR) and claims Data, the Data silos and barriers to access. Other topics that need to be addressed are the limited interoperability standards, the level of experience int he different sites and the Technology constraints. All these points will vary from site to site and this heterogenicity can influence the outcome of the registry, study or clinical trial.
Interestingly, the region is characterized by large families, older maternal and paternal age, and a high rate (25–60%) of consanguineous marriages. Therefore, the risk for genetic disorders is higher than in other regions of the world, this disorders account for the majority of rare diseases in the Middle East and are responsible for an important share of infant mortality, morbidity, and handicaps in Arab countries. Genetic disorders such as hemoglobinopathy, glucose-6-phosphate dehydrogenase deficiency, autosomal recessive syndromes, and several metabolic disorders are present in the Middle East, such as hypoparathyroidism (lack of parathyroid hormone) and beta thalassemia (a blood disorder that reduces the production of hemoglobin). Other genetic disorders are more specific to regions or populations, for example glutaric aciduria type I, an organic acid disorder where individuals cannot metabolize the amino acids lysine, hydroxylysine, and tryptophan, in Israel.
Other rare diseases related to infections, such as Behcet's disease (characterized by genital ulcers, skin lesions, and uveitis) though very rare in the United States, is more common in the Middle East and Asia, suggesting a tropical-area cause. Another example is Pemphigus, the general designation for a group of autoimmune skin diseases that cause ulceration and crusting of the skin that is present in people of Middle Eastern or Jewish heritage.
On the regulatory side, it takes between 3 to 6 months from the first application to the ethics committee to the SIV (Site information Visit), which officially opens the site for the study.
Hiring the best manager with vast experience in the region is the main factor to ensure a pristine execution of a study and to leverage the potential of the RWE in the MENA region. This area has a lot to offer and still needs more attention to successfully conduct studies that produce the RWE that will have an impact not only on the patients in this region but also in the world.
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