12 April 2020
From streamlining regulatory framework to accelerate trials, to building the right infrastructure across hospitals and research centres, and investing in international, mutually beneficial partnerships, panelists agreed that while the kingdom has come a long way with advancing clinical trials, there is still much to be done.
The experts laid out five key elements to develop clinical trials in the kingdom; government support to ensure a clear, quick, collaborative and standardized regulatory process, raising awareness about the importance of clinical trials, investing in healthcare infrastructure and research and development (R&D), collaboration, and ensuring a well-connected, rich patient database.
Towards a sleeker regulatory framework
Many discussions centred on streamlining the regulatory framework governing clinical trials. A proposed clinical trial must be approved by a regulatory body after close scrutiny of the process, and a study to ensure safety of the participants. Without a clear regulatory framework that ensures timely approval, without compromising quality or safety, clinical trials cannot progress quickly enough for pharmaceutical companies to be encouraged to run operations in a particular country.
Adeel Chaudhary, professor of human molecular biology at King Abdulaziz University (KAU) explains that developing national policies is essential to attract pharma companies. A national policy that ensures the ease and ethical participation of patients in trials, and therefore attract global industry players to carry out operations and research in the kingdom. Ensuring hospitals are aware of ethical regulations, and have the relevant literature, and consent forms, is essential to ensure pharma companies are able to conduct their research and trials safely and effectively, within an acceptable timeframe.
“You have opportunity to set the stage to be one of the best clinical trial sites on the planet, so it is important to make sure the pipeline doesn’t get bogged down,” said Walter Klemp, the chairman of Moleculin biotech company.
Reducing the time needed to execute a trial, without jeopardizing quality, credibility and reliability is also important. Ahmed Bahammam, executive director of King Saud University (KSAU) explained that, around the world, the standard timeframe to approve a trial and get started, is 151 days, while the average time in the kingdom is 9-12 months.
This is not to say that regulations should be relaxed, experts stressed the importance of maintaining a tight grip on standards, regulations and ethical considerations. John Johnston, clinical assessor at the UK’s Medicine and Healthcare Products Regulatory Agency (MHRA), explained that tension between institutions conducting clinical trials, who focus on the efficacy of drugs tested and the regulatory agencies charged with ensuring safety, is essential to ensure balance.
There must be clear procedures and timelines so researchers know when they can expect each step of the process to take place. “Companies do not like delays because they cost money,” said Johnston. “Pragmatism, and an understanding that this will bring treatment to a patient are important.”
Amit Sadana, general manager of IQVIA, agreed, adding that more transparency and predictability in terms of the regulatory timelines are essential.
The kingdom also needs to properly plan for the number of assessors needed to ensure a smooth process of approvals. Johnston explained that in there are roughly five assessors in MHRA, and each assessor can examine five to eight clinical trial files every week.
Getting the word out on clinical trials
Participation is key to clinical trials, and timely recruitment is integral, which is often challenging for phase I clinical trials. Kim stressed the need to raise awareness about the importance of clinical trials and their potential for improved health. “The patients’ willingness to participate in the trial for the sake of their health or treatment is fundamental,” said Yon Su Kim, president and CEO of Seoul National University Hospital (SNuH). “You need to build patient awareness to be able to expand your program.”
The patient-to-clinical-trial ratio is high in Saudi Arabia, which means that it should be easy to recruit patients if the willingness is there. “In the U.S. there are more than 16,000 Acute Myeloid Leukemia (AML) patients, but there are 593 clinical trials; so the ratio is 28 patients per trial, whereas the average clinical trial size is 44 patients,” said Klemp. This means that it took one year to recruit three patients to the trial. “In Saudi Arabia, there are 825 patients for each trial, so how long would it take us to recruit the first patients of a trial?” Alain Moussy, co-founder of AB Science, explained that one of the three main criteria for biopharmaceutical companies to run clinical trials is the number of patients available to participate in clinical trials, the two others being quality of the trial and the cost. “Here in Saudi Arabia, you’re almost number one [on the number of patients front],” said Moussy.
In addition to encouraging participation from the general population, medical professionals and students also need to realize the importance of trials. A fundamental change in the medical education system is therefore crucial. Adeel Chaudhary, professor of human molecular biology at King Abdulaziz University (KAU), stressed that medical students, researcher and practitioners need to be aware of the importance of clinical trials and of their standards of practice.
Investing in the future
Investing in infrastructure and primary research that fosters an environment of translational research is an important element of developing healthcare in Saudi Arabia.
Klemp cited the example of Poland, a country of similar size and GDP as Saudi Arabia. While Poland has a 33 million population and 2 billion GDP, Saudi Arabia has a 38 million population and 5 billion GDP. Healthcare spending is also similar in both countries. The number of Cclinical trials that were held in Poland, however, is 6,296, this compares to 660 in Saudi Arabia. “The growth rate of clinical trials in Poland was astronomical, in 2011, the number of clinical trials held in Poland was less than that in the kingdom,” said Klemp. “The European Union, however, engaged in a massive effort to simulate investment in biotech, and there was a 0 million investment in that industry.”
Promoting investments in medical research, and clinical trials in particular, will also help localize the biotechnological and biopharmaceutical industries. Abdulrahman Al Faifi, chief advisor for industrial clusters at KAU, explained that across industries, only 2% of the demand is met locally. “In 2020, we’re targeting the medium technology devices, which are needed in the kingdom,” said Abdulrahman. There are plans to increase that percentage to 15% by 2030. Currently the size of the pharma market in Saudi Arabia is close to billion, and this number is expected to grow to .3 billion by 2023, but local pharma production only represents 20% of sales.
Researchers must also think about commercialization potential of their projects. Ali Alessandro Ayach, a senior director of GE Healthcare, explains that there is an opportunity to refocus clinical trials in Saudi to match demand, and at the core of this model is commercialization potential. “We also need proper financial management to bring entrepreneurial concept at the beginning of each clinical trial to make sure the project can be commercialized to a certain extent,” he added.
Stronger in numbers
Cross-country and international collaborations can also push clinical trials forward, experts agreed. Single, isolated sites represent almost 50% of clinical trials held in the kingdom, and only 8% of the trials are held across multiple sites. “Collaboration within the kingdom is important and will help in understanding patterns to help focus and direct funds for positive outcomes,” said Ayach.
Experts agreed that the basis of research is knowledge of the population. They argued that it is crucial for researchers to gain insight on the prevalent diseases in a country, genetic composition of the population, commonly used treatments, and more crucial information to determine which areas of research to prioritize, as well as be able to recruit relevant participants for trials in a timely and efficient manner. Bahammam explained the importance of a database between big hospitals, primary care centers as well as between clinical trial units that encourages collaboration and information sharing. “We need a network between the sites that have clinical trial units to facilitate the transfer and communication of information across those sites and share experiences,” he added.
Kim cited South Korea’s dramatic increase in clinical trials, explaining that the quality of available data was key to their progress. The biggest hospitals in South Korea were early adaptors of electronic medical records, connecting all their patients’ data over the past 10 years. “So all the data is available and we can recruit from the database and see how many candidates we have and how many there might be in the future,” said Kim. “This kind of database is very important and [it is based on] good connection and collaboration between the big hospitals.”
KAIMRC has already led several initiatives to engage research and medical centers around the kingdom. One of the key projects, for instance, is the Saudi biobank, which aims to enroll 200,000 samples to support genetic and epidemiological research studies in the kingdom. The Ministry of National Guard-Health Affairs (MNGHA) has also been working to connect and consolidate patient databases across hospitals around Saudi Arabia.
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