Invited Speaker

Globalization Of Pharmaceutical Development- Role Of Middle East
Vladimir Misik
Austria

The past decade witnessed significant increase in globalization of clinical trials sponsored by pharmaceutical companies, with main contributors (and beneficiaries) being Central and Eastern Europe (CEE), South East Asia (SEA; mainly India and China), Latin America (LA), and South Africa. Main driver for globalization of clinical trials, traditionally almost exclusively performed in the developed countries (mainly North America and Western Europe), was access to eligible patients and cost-saving.

Increased globalization raised some concerns both in developed countries (about quality and integrity of data obtained from emerging regions) as well as within the emerging countries themselves (concerns about exploitation: “human guinea pigs”). Little evidence to support either of these concerns has been found: indeed recent article (JPE Karlberg, Clinical Trial Magnifier 2 (2009) 194-212) based upon analysis of US FDA inspection findings between 1997-2008 concluded that statistically significant higher percentage of deficiencies have been reported in Western Europe, followed by North America, and Rest of the World (RoW) countries, with Eastern Europe having the best overall results. Worth noting is also that no inspection outside of the US reported submission of false data. These quality results coupled with the fact that majority (87.1%) of clinical trial sites are still located in North America, the European Community and other developed countries (with only 12.9% of sites located outside of the developed countries with majority of the studies conducted in those countries being large scale phase III - and thus confirmatory in nature and not exploratory early stage), led the authors conclude that concerns about increased globalization are unfounded since RoW is conducting low number of risky early stage studies, and the RoW data provided have been found of equal or better quality vs developed countries. These data are the best answer to critics of globalization and show that pharmaceutical companies concerned with data integrity (and thus acceptability of data to US FDA and well as other regulatory agencies) have been careful when selecting new countries and sites and have provided adequate oversight (monitoring) during the study conduct.

While other emerging regions benefited from globalization of clinical trials and managed successfully to direct significant portion of the ~$100m global pharma development spent (with associated know-how, technology, and cutting-edge therapies) into their countries, participation of Middle East sites has been very low: while approximately 4,000-6,000 clinical studies are performed each year in the EU member states, of those approximately 64% sponsored by pharmaceutical companies, (EU report: Assessment of the Functioning of the “Clinical trials directive” 2001/20/EC, Oct 2009), number of pharma-sponsored clinical trials reported on clinicaltrials.gov over a period 2006-2009 has been as follows: Turkey 295, Egypt 62, Lebanon 38, Saudi Arabia 35, UAE 11, Jordan 11, Kuwait 8, Bahrain 4, Qatar 4, Syria 3, Oman 3.

There is a unique opportunity to increase participation of ME sites in global pharma development driven largely by two factors: a/ Middle East is now firmly on the map of all major pharma companies, being one of the fastest growing regions globally (next to India and China), and b/ reputable multinational CROs are now present in the region. Considering the ~ 200m population in the Middle East, or approx 2/3 of the population of CEE (which has been providing approx 20% of the ~1 million patients recruited annually globally into clinical trials) we estimate Middle East’s potential to be 7-10% of the global figure or ~70,000 - 100,000 patients per year; assuming direct and indirect fees and expenses this represents annual potential of approx $1bn of pharma development spent to be directed to the Middle East. What is expected from local stakeholders for this to happen: (1) hospitals: a/ existence of IRBs with working procedures as per ICH GCP and b/ existence of clinical research coordinating unit, (2) governments: a/ regulatory authorities with well-defined processes and predictable timelines working to international standards, b/ simplification of customs barriers of import and export and study material.

Aware of the benefits, some governments in the region have taken active steps to attract pharma development to their countries: Turkey and Jordan have adopted laws on clinical research, Syria recently enacted ministerial decree on clinical trials, and a similar decree is under preparation in Egypt. Sharing experience from regional success stories and attempts to harmonize regulatory requirements and approximate them on international standards would provide necessary boost to the region’s bid to become significant player in global pharma development.