Register now or log in to join your professional community.
good answer by Mr emmad above
I fully agree with the answers been added by EXPERTS................Thanks.
Clinical trials in the Middle East and North Africa (MENA) Region:
Nearly% of the world's clinical trials are conducted outside the US and% 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 diseasesin the MENA countries should be associated with a consequent scale-up of clinical trialsin these countries. However, the region sponsors under1% 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 analyzedto 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 andoversight requirements. Barriers related to trial quality and subject protection can be mitigatedby risk-based monitoring. Growing healthcare infrastructure and communication technologiesprovide clear advantages for subject recruitment. Low operating costs combined with theincrease 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 conductof clinical trials specific to each MENA country.
Conclusion:Challenges in drug importation and site oversight can be overcome with systematicinterventions. Social media network and community awareness programs can assist reductionsin barriers in obtaining effective informed consents. Increasing pharmaceutical sales, populationgrowth, high prevalence of genetic and life-style related diseases and reduced clinical trialdevelopment costs offer expanding opportunities for future clinical trials in MENA.
