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International Clinical Trials

On the Map

The MENA region – extending from Morocco to Pakistan – is generally one of the fastest growing economies in the world, and one of the industries enjoying this increase in demand is the clinical research sector. Key factors for this include: a large treatment-naďve population;the improvement of the healthcare infrastructure; and the large number of therapeutic indications.

Rising drug-development costs and pressing needs to advance drugs quickly are pushing global pharmaceutical companies to look for emerging markets in which to conduct clinical trials. As sponsors and CROs are still on the hunt for emerging markets with extensive treatment-naďve patients and good infrastructure, the interest in the MENA is increasing. The region is projected to be one of the fastest growing markets for clinical research based on availability of the required infrastructure, access to necessary patients, faster timelines, and lower cost compared to other markets. The attractions of the MENA as a location for clinical research include: patient diversity; world-class medical facilities; cost advantages; and favourable regulations. Indeed, multinational CROs believe the region is about to experience a surge in clinical trials.

Trial Growth

As of 9th January 2013, 1,738 studies were under way in the 14 countries that the FDA considers part of the region, according to ClinicalTrials.gov. That’s 1.25 per cent of the 138,511 trials registered across the globe – still small, yet a significant increase from the 2006-2009 period, when there were just 400 trials in the region. While the pharmaceutical industry projects four per cent of its sales will come from the region, only 0.4 per cent of trial participants currently come from the MENA, which has a population of 380 million.

According to ClinicalTrials.gov, Turkey has 1,125 trials, followed by Iran with 503, Saudi Arabia with 230 and Lebanon with 161. These numbers remain very low compared to the reality as these are only the trials registered by international sponsors on ClinicalTrials. gov; this is the reason why the World Health Organization is currently encouraging the setup of a local clinical trials registry database in order to have a more accurate estimation.

Advantages of the MENA

Low Cost
Since the MENA countries are still in the emerging phase as far as clinical research is concerned, the costs for conducting clinical trials are not as high as in the US or Europe. This is a benefit as most global companies are currently seeking to limit the costs of clinical trials.

Population
Meeting patient recruitment and enrolment targets is the number one problem in clinical research globally, which is slowing down drug development. To speed up drug development, pharmaceutical companies should consider what the MENA region can offer: access to large patient pools, as well as local and international expertise.

Getting a head start in the MENA markets, with a huge population available, could also prove to be a strategic advantage. The MENA region has a predominantly young population compared to an ageing population in the West. It is one of the fastest growing regions in the world, and is expected to grow in double digits in the next few years, offering a wide range of patients and specific disease areas. The region has a unique patient population with high disease prevalence. In fact, it has more than 500 rare genetic disorders and a high prevalence of cancer, hepatitis, diabetes, obesity, cardiovascular disease and asthma.

High Cancer Prevalence
Cancer prevalence in the MENA is relatively high at 60-216 occurrences per 100,000 people (breast, lung, colorectal, prostate). This is mainly due to risk factors such as smoking (where 50 per cent of males over 15 years of age are smokers), obesity (over 50 per cent of the population have a BMI higher than 25), genetics, and infections (27 per cent suffer from human papilloma virus, 23 per cent from Helicobacter pylori, and 20 per cent from hepatitis B and C virus). The high prevalence of cancer led to the increasing number of comprehensive cancer centres and Joint Commission International accredited medical centres in the MENA region, with the availability of highly qualified and trained key opinion leader physicians/ physician investigators.

Expertise
It is also important to note that expertise in the MENA is quite sophisticated and as good as the western standard. Many of the physicians have trained in major centres in Europe and the US, which translates to international as well as local expertise. This cannot be found in other parts of the world. As for the sites, they have: a low number of competing studies; a highly centralised healthcare system; a significant number of treatment protocols which conform to US/EU standards; a high level of interest from hospitals and doctors (investigators) to participate; investigators western-trained with an excellent command of English; and hospital source documents in English/French.

Political Issues
The volatile nature of the region is an important topic, and managing trials during political unrest is a concern some view as a ‘red flag’, but this should not be the case. We have seen from previous crises that unless there is a large-scale military involvement, local unrest or political disruption, there tends to be minimal impact on business. There is a deep understanding in the community of the importance of not letting disruptions get in the way of business.

Regulatory Submissions and Timelines
Timelines are improving across most of the region. Also boosting confidence in the region is the fact that the FDA is now working to open an office in Jordan. Clinical trial approvals in MENA region countries can be complex and time-consuming. Comprehensive local knowledge is of great importance and can expedite approval timelines. Therefore, it is imperative that pharmaceutical companies and CROs have a clear understanding of the regulatory requirements in the MENA region in order to obtain timely approvals and fast study start-up. Due to the complex requirements of the ethics committees and regulatory authorities in the different countries across the MENA, it is recommended that the advice of local regulatory experts be sought to minimise delays during start-up activities.

Conclusion

The MENA is of great importance to clinical research and has not yet reached its full potential as the number of studies being performed continues to grow. The increase in clinical research in the MENA is the result of a collaborative, multidisciplinary effort of the regulatory authorities, ethics committees, investigators, pharmaceutical companies and CROs. The continuation of this cooperation is the key to the further development and the establishment of the MENA on the global market for clinical research.

References

1. Qatalyst Global, Promoting Clinical Trials MENA, Dubai, UAE, October 2012
2. Foreign Exchange Translations, Middle East presents opportunities, challenges for clinical research, February 2012
3. Redfearn S, Middle East region poised for clinical trials growth, CenterWatch, October 2011
4. Kermani F, How to run clinical trials in the Middle East, Scrip Intelligence, 2012
5. Abraham R, MENA: The Dawn of a New Era, Applied Clinical Trials Online, April 2011

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Dr Nadia Cheaib is President and CEO of ClinGroup Holding and ClinServ. She founded ClinServ 11 years ago in Paris and then extended to the MENA region in 2006. She has over 18 years of worldwide progressive knowledge of healthcare product evaluation, involving multiple senior responsibilities in quality assurance, medical writing, regulatory affairs and clinical operations within European CROs and pharmaceutical companies. ClinGroup Holding is a global healthcare solution provider of clinical research in terms of operations, logistics, quality and information. Nadia is also President of the Middle East Clinical Research Association, which plays a major role in the development of clinical research infrastructure in the region.
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