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International Clinical Trials

The Middle East and North Africa

The Middle East and North Africa (MENA) remains a highly under-represented region for clinical studies. As of 11 April 2016, there were 212,454 clinical trials registered in the clinicaltrials.gov database, and less than 2% were listed as ongoing in MENA.

This brief overview will not include Turkey, a country that is considered by some to be part of this extended region. Turkey has witnessed an extensive expansion in its clinical trials, which can be largely attributed to changes to its regulatory landscape. Israel, a country that has more than 8,000 trials listed on clinicaltrials.gov and has been involved in clinical research for over two decades contributing high-quality data – mainly in early stages of clinical development – will also not be covered.

Central on the worldwide map, MENA – the bed of civilisation of the three monotheist religions – remains largely overlooked for clinical trials. Speaking about the number of studies occurring in this region, the public source based on clinicaltrials.gov is misleading. Data suggest that there are many locally initiated studies by academics and/ or pharmaceutical companies, and these trials are often not registered on clinicaltrials.gov – particularly if they are not part of a global study for registration. Communications with local agencies suggest that the actual amount of ongoing studies can, for some countries, be three to eight times higher than the ones reported in the clinicaltrials.gov database.

Although the landscape is changing, the interest in the region remains limited. This is due to various factors, including the restricted number of clinical research organisations present and/or involved in the area (21 million kilometers square and over 300 million population), and fewer than 10 of the large international CROs are physically present – most are local and regional CROs. The various regulatory agencies in the region have made major advances in the establishment of regulatory guidelines that are often similar to ICH. All the countries in the region, even the ones with nascent agencies, generally follow ICH guidelines and Helsinki recommendations.

The perception of safety is often in the general psyche, and mainly due to the news and media – in fact, not all countries in the region are equal. If we exclude the countries that are at war, the others are as geopolitically stable as Asia, South America or Eastern Europe. The quality of hospitals in these countries is better than expected. Most of the Middle East is part of the developed world and the remaining region is primarily part of the newly developed economies, with medical infrastructures similar, if not superior, to the ones found in Eastern Europe. This area provides access to large Caucasian populations affected with diseases similar to those in the West, including cancers and cardiovascular and respiratory diseases.

Additionally, MENA presents a very unique area to access patients with rare genetic disorders. At a time when there is a renewed focus on orphan diseases, it is surprising that more studies are not being conducted in MENA – a region with higher consanguinity than the West. The area may have less experience in clinical trials, but it has the same potential Eastern Europe presented to the world when the EU was extended to 25 countries. During this period, our horizons turned to Poland, Czech Republic, the Baltic countries and other non-EU locations. Today, it seems odd to dismiss over 300 million potential patients in MENA out of ignorance and prejudice, as this region should be considered for clinical trials in much the same way as all the regions we rely upon to date.

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Dr Cellia Habita, MD, PhD is the Chief Executive Officer of ARIANNE, a full service clinical CRO and consulting group for biotechnology and pharmaceutical companies. Her CRO covers 25 countries, including MENA, and facilitates clinical trials in various therapeutic fields from the earliest through the latest stages of development (Phase 1 to 4). Cellia also provides strategic drug and clinical development advice to several US and international companies and venture funds. Her 20 years of experience includes broad scientific and clinical expertise in various therapeutic areas such as oncology, dermatology, ophthalmology, endocrinology and infectious diseases. Besides her medical diploma, she holds a Master’s in Biology and Genetics of Aging from Paris VII University, France, as well as a PhD in Genetics.
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