Nihal El Habachi
AlexandriaUniversitySchoolofMedicine,Alexandria,Egypt.
Title: Clinical trials in Egypt: Opportunities and Challenges
Biography
Biography: Nihal El Habachi
Abstract
Egypt's global share from clinical trials is very small in spite of being a strategic country in MENA region with large population.
There are lots of opportunities attracting pharmaceutical companies to invest in the field of clinical trials in Egypt as the low expenses represented in the Investigator & site fees , cost for trial-related care and much lower overhead fees, travel costs for monitoring sites and Support services (as printing, translation, and local courier fees).
Also, the high quality investigators and site staff, keen to participate in clinical trials. As well as, Large pool of trial-naive, often treatment-naive patients, High incidence and prevalence of certain diseases and less competition for enrolment of patients.
On the other hand, there are lots of challenges facing people working in clinical trials as unexplained disapproval set by the concerned Authorities on the exportation of the biological samples to central labs, prolonged and undefined/unpredictable study approval/start-up timelines, absence of national clinical research law regulating clinical research and absence of national database registry for clinical trials.
Challenges regarding research subjects, investigators, REC, regulatory authorities, sponsors and local facilities as well as our ways to overcome them will be discussed.