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Saudi Arabians use about 0.5 percent of the global pharmaceuticals market, but the country’s contribution amounts to only 0.02 percent of the global clinical trials held. This means the kingdom is losing precious opportunities to contribute to customizing treatments to the genetic predispositions of its people.
“Saudis mostly consume drugs that they weren’t part of developing,” said Vladimir Misik, president of Long Taal, a company specialized in clinical trials analytics.
KAIMRC is trying to improve these figures. It has already launched a clinical trials project and is now a leader in the kingdom, in terms of attracting international clinical trials. Globally, clinical trials attract an annual investment of $120 billion, with 1.5 million patients receiving new treatments for free. “KAIMRC is trying to implement this project with medical research centers in the kingdom to secure 1 percent of this international investment, generating a financial return of $300 million to the kingdom, and 4,000 medical jobs, while 10,000 patients get new, free treatments annually, thus minimizing the need to travel abroad for treatment,” said Ahmed Alaskar, KAIMRC’s executive director.
The collective efforts of the industry have been fruitful, and clinical studies have increased by 20 percent from 2016 to 2018, according to Yaseen Al Arabi, chairman of the intensive care department at King Abdulaziz Medical City. Internationally, the number has gone up from 9,400 to 11,000 in the sameperiod; an increase of about 17 percent. KAIMRC has conducted 180 clinical studies in the past five years.
But it isn’t yet enough.
Phase I clinical trials are especially challenging, there are currently 737 phase I clinical trials in the Middle East region. Meanwhile, there are 64 phase II clinical trials held in the kingdom; this represents around 3.4 percent of the phase II clinical trials held in the region. Like any country, phase III trials have the highest number, standing at 202 trials in the kingdom.
Towards a more customized treatment
Experts agree that it is essential to increase the number of clinical trials held in the kingdom to improve the pharmaceutical industry and better benefit from treatments. “Saudi Arabia spends $8 billion on pharmaceuticals,” said Refaat Taher, managing director for Healthcare and Life Sciences at the Saudi Arabian General Investment Authority. “These drugs can be better developed to suit the specific genetics of the Saudi population if we play a bigger part in clinical trials.”
To bridge the gap between the drug consumption in the kingdom and its participation in clinical trials, Misik estimates that 1,500 clinical research professionals are needed, a far cry from the current 100. To achieve this, Misik suggested clinical research programmes, teaming up with universities in theUnited Kingdom and the United States with a long history of running similarprogrammes. Taher also recommended forming an organization specializedin training the staff and collaborating with these universities abroad. “We also need a mentoring system where young researchers are trained by older ones,” advised Al Arabi, adding that it is important to work towards retaining staff and minimizing turnover to ensure familiarity with the system and meeting the international standards. Non-academic research residencies and fellowship programmes could also help find and retain qualified staff, suggested Al Mazroo, vice president for the drugs sector at the Saudi Food and Drug Authority.
The Saudi government, in collaboration with various stakeholders, has already taken several steps towards increasing clinical trials. The Investment Authority has started a committee with representatives from pharma groups, regulators, the Saudi Food and Drug Authority, individual companies and other stakeholders in clinical trials and research and development. “We ask everyone‘what do we need to bring funding of multinationals?’ So we ask them to namefive things we need to change to bring research and development funding to Saudi Arabia,” said Taher.
Attempting to drastically increase the number of clinical trials and programmes in the country, however, has risks. Experts, therefore, recommend starting small and with institutions that are more developed, rather than trying to implement the programmes nationwide all at once. It may also be more efficient to focus on increasing the number of phases II and III clinical trial participants before moving to phase I.
It is also essential to evaluate the lengthy process of approvals to minimize the time between submitting the proposal for a clinical trial and recruiting the first patient. “There is a need to evaluate that value chain and address the issue of approvals,” said Al Mazroo.
