Clinical trials in the Middle East and North Africa (MENA) Region: grandstanding or grandeur?
BACKGROUND
Nearly 31% of the world's clinical trials are conducted outside the US and 25% of the new drug applications include data from international sites. The high population growth, demand for medication, increased prevalence of life-style related and rare genetic diseases in the MENA countries should be associated with a consequent scale-up of clinical trials in these countries. However, the region sponsors under 1% of global clinical trials.


METHODS
Determinants including the regulatory environment, patient protection, physician-preparedness, types of diseases, costs of trials and pace of subject recruitment, were analyzed to identify critical factors that influence barriers to the conduct clinical trials in MENA.


RESULTS
Strategic planning by the CRO can help overcome challenges related to regulatory and oversight requirements. Barriers related to trial quality and subject protection can be mitigated by risk-based monitoring. Growing healthcare infrastructure and communication technologies provide clear advantages for subject recruitment. Low operating costs combined with the increase in pharmaceutical sales provide incentives for the future conduct of clinical trials.


LIMITATIONS
Although the opportunities and challenges cited are common to the MENA region, further studies are needed to assess other potential contributing variables for the conduct of clinical trials specific to each MENA country.


CONCLUSION
Challenges in drug importation and site oversight can be overcome with systematic interventions. Social media network and community awareness programs can assist reductions in barriers in obtaining effective informed consents. Increasing pharmaceutical sales, population growth, high prevalence of genetic and life-style related diseases and reduced clinical trial development costs offer expanding opportunities for future clinical trials in MENA.
['Nair|Satish Chandrasekhar|SC|', 'Ibrahim|Halah|H|', 'Celentano|David D|DD|']
D000293:Adolescent D000328:Adult D000352:Africa, Northern D000368:Aged D002986:Clinical Trials as Topic D017046:Cost Savings D003906:Developing Countries D017277:Drug Approval D004345:Drug Industry D005260:Female D006784:Hospitals, Teaching D006801:Humans D007258:Informed Consent D008297:Male D008875:Middle Aged D008877:Middle East D018579:Patient Selection D012577:Schools, Medical D055815:Young Adult
Clinical trials Regulatory Recruitment Disease pool Gas price index Middle East North Africa