How to run clinical trials in the Middle East - Saudi Arabia
This article was originally published in Scrip
The population of Saudi Arabia is around 27 million, with a GDP per capita of $20,700. The country's healthcare expenditure represents 3.4% of GDP – $379 per capita based on 2006 figures.
Saudi Arabia's wealth has grown over the past few decades as a result of oil revenues. At the same time, it has seen a surge in the incidence of non-communicable diseases. As the population became richer, the amount of exercise undertaken has fallen away, and diets comprising mainly lean foods were replaced with those with high fat content.
Saudi Arabia's population growth rate and total fertility rate (TFR) are the highest in the Gulf and among the top three in the Middle East North Africa (MENA) region.
The Saudi population is projected to increase to almost 28 million by 2013. The government says it will not be able to sustain healthcare finance at the current level. Therefore, it is looking to restructure the health sector, moving facilities from the public to the private sector. The government hopes this move will increase the quality of domestic healthcare services so that patients will not seek advanced treatment abroad as often as they do today. Access to healthcare in general is 100% for Saudi citizens.
Source: TrialTrove; Chart: Paul Wilkinson/Sneha Sowdi
Clinical trials in Saudi Arabia are overseen by the Saudi Food and Drug Authority (SFDA), which was established in March 2003. The guidelines on clinical trials, which are in line with global standards, were issued by the SFDA in 2006 and should be fully implemented this year. The SFDA has also published the "Regulatory Framework for Drugs Approval", which offers information on the requirements for the conduct of clinical trials. Protocol approval for pre-marketed products takes about 20 weeks.
CROs generally agree that Saudi Arabia is a good place to carry out clinical trials because:
- it has allocated $32 billion towards higher education, training, science and technology and academic R&D;
- it spends $6.5 billion on private and public sector hospital and clinic projects;
- it has a large population base, with only 4% over the age of 65 years;
- it is developing regulations to match global standards in clinical trials;
- it has world-renowned research centres, such as the King Faisal Specialist Hospital and the King Fahad National Guard Hospital;
- it is developing pharmacovigilance guidelines;
- more than $25 million has been set aside to establish regional labs in different provinces. The move towards decentralisation of the healthcare system in general is viewed as good for patient recruitment;
- studies are conducted according to ICH/GCP and adherence is good;
- the King Faisal Hospital and Research Centres (KFSH&RC) in Riyadh and Jeddah have developed their own regulatory framework and, as such, are able to oversee and approve Phase II-IV clinical trials; and
- clinical trial data are accurate and traceable.
The Research Advisory Council at the KFSH&RC promotes clinical and biomedical research and oversees ethical and clinical standards. It ensures that trials adhere to global ethical and safety standards, as well as the optimum use of resources. The SFDA is looking to use the KFSH&RC to oversee clinical trials across the kingdom.
Datamonitor believes that pharmacoeconomic analysis will be used in both private- and public-sector drug procurement. Insurers will look for methods to cut cost – pharmacoeconomic evaluations of drugs will therefore provide a powerful tool to curb pharmaceutical expenditure.
Multinational pharmaceutical companies should adopt a more localised approach to presenting data through the conduct of clinical trials in Saudi Arabia, especially for those that address some of the chronic conditions increasingly prevalent in the kingdom. This strategy would capture nuances specific to the region (such as ethnic genotypes that are common in the area), which have contributed to the significantly higher prevalence rates of chronic diseases, such as diabetes. Obtaining positive results from localised trials can generate better buy-in from the SFDA where pricing of pharmaceuticals is concerned, as well as from payers over drug reimbursement.
Outcomes from randomised clinical trials can also provide pharma companies with the opportunity to execute product life-cycle management strategies, such as indication expansion opportunities or dosage modifications, which could add to the feasibility of such strategies.