Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

How to run clinical trials in the Middle East - Saudi Arabia

This article was originally published in Scrip

Executive Summary

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.

Figure 6. Clinical trials in Saudi Arabia
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.

You may also be interested in...



MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins

In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.

EMA Acts To Freeze GVK Drugs, Guard Against Shortages

The EMA has recommended suspension of some 700 drug formations linked with Indian clinical trials company GVK Biosciences, but assures national agencies that this won’t result in shortages or safety issues.

EMA Acts To Freeze Drugs Linked to GVK Bio, Guards Against Shortages

EMA has recommended suspension of some 700 drug formations linked with Indian clinical trials company GVK Biosciences, but assures national agencies that this won’t result in shortages or safety issues.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

SC007094

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel