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Challenges of the MENA region and how we overcome them

12:28 15 March in Blog

Challenges of the MENA region and how we overcome them

Conducting clinical trials in the Middle East and North Africa (MENA) region offers a multitude of opportunities, yet it also presents unique challenges that biotech companies must carefully navigate. Understanding and effectively addressing these challenges are essential for ensuring the success and integrity of clinical research endeavors in the region.

 

Fragmented Regulatory Landscape:

From what I have noticed, the western perspective of the region is more of a conglomerate, as in operating in a unified fashion. Unfortunately this is far for the truth. The MENA region is a huge area consisting of over a dozen countries. Each of those operate under their own laws and regulations. Therefore, one of the primary challenges facing clinical trials in the MENA region is the fragmented regulatory landscape. Each country within the region may have its own set of regulations, approval processes, and requirements for conducting clinical research. Navigating this complex regulatory environment demands meticulous planning, clear communication with regulatory authorities, and a comprehensive understanding of local regulations to ensure compliance and timely approval of clinical trials.

 

Limited Research Infrastructure:

Now, we previously discussed one of the benefits of operating in the region being the availability and readiness of patients to join clinical trials. Particularly for orphan diseases, many of those patients are found in rural areas. While major urban centers in the MENA region boast advanced healthcare facilities and research infrastructure, conducting clinical trials in more remote or underdeveloped areas may pose significant logistical challenges. Limited access to specialized medical equipment, trained personnel, and research facilities can hinder the conduct of clinical research.

 

Cultural and Linguistic Diversity:

The MENA region is characterized by rich cultural diversity and linguistic differences, which can impact communication and participant engagement in clinical trials. Effective engagement with diverse patient populations requires culturally sensitive approaches and linguistic diversity in study materials and communication channels. Biotech companies may be averted from the region because of this cultural diversity unknowing that most of the countries do NOT require translation of synopsis, protocol and eCRF. That is because all of the healthcare staff are educated and speak multiple languages.

This is not a challenge that is faced in the MENA region; in fact, that is a huge benefit of the region. We all know that breaking linguistic barriers will lessen the human error rate and thus having a competent and multilingual staff supports clinical trials and facilitates communication with both the patients and the sponsor.

 

Ethical and Socio-cultural Considerations:

Ethical and socio-cultural considerations play a pivotal role in the conduct of clinical trials in the MENA region. Respect for cultural norms, values, and beliefs, as well as adherence to ethical principles and human rights standards, are fundamental to ensuring the ethical conduct of research. For example, when conducting DCTs, some of these ethical and socio-cultural differences may pose a challenge.

 

The aforementioned challenges biotechs may face should not be a deal breaker. The eventual pros of expanding their trials to the region, in many cases, outweigh the minute cost of these challenges. I would argue that reaching the target patient number and securing a strong power for a study would always outweigh having to make certain regulatory or socio-cultural changes.

In conclusion, while conducting clinical trials in the MENA region offers immense potential for advancing medical research and improving patient care, it also presents multifaceted challenges that require careful consideration and proactive management. By addressing regulatory, logistical, cultural, and ethical concerns, biotech companies can overcome challenges and leverage the unique opportunities offered by the MENA region to drive innovation and accelerate the development of life-saving therapies.

Omar Al Koussa

Business Development Executive

(BDE)