Chapter 12 - Clinical Trials in the Middle East and North Africa

Abstract

Clinical trials in the Middle East and North Africa are explained in this chapter. During this quest for new regions, the Middle East and North Africa (MENA) has been quietly developing a strong infrastructure, powered by highly qualified human resources and supportive governments. The number of clinical trials conducted in the MENA has been increasing in the past few years. The MENA region has been occupied by small local CROs for several years, offering services mostly to the pharmaceutical industry within the region. The modest volume of clinical research in the MENA implies a limited volume of experienced local human resources in the field of clinical research. The Saudi Food and Drug Administration (SFDA) is the official regulatory authority for clinical trials in Saudi Arabia. Established in 2003, the SFDA employs many of the US FDA regulations with respect to clinical trials. Increasing literacy rates also allow for better consent of patients and better patient compliance. As in the case of every emerging market, the MENA presents a number of challenges. Culture is definitely an important challenge where the research culture is not yet well established among the population. Patient compliance may also be questioned during Muslim holidays and Ramadan, which also affects regulatory timelines and slows approval processes. Political instability is another challenge in the MENA, and represents a justifiable factor in deciding whether to run a clinical trial in the MENA or not. The clinical trial staff is available, qualified, and motivated