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International Clinical Trials
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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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