Hong Kong needs to capitalise on its strong fundamentals to establish itself as a clinical research hotspot within APAC and support its transition into China’s innovation and technology hub. Does a new one-stop-shop for clinical trials across the Greater Bay Area hold the key?
Clinical trial numbers are skyrocketing across the Asia-Pacific region. Local, regional, and multinational players from both the public and private sectors sponsored 14,346 trials in APAC in 2023 and numbers have been growing by double digits over the past five years. This is being driven by the region’s large and diverse patient population, high disease burden, increasingly favourable regulatory environment, cost-efficiency, government support and infrastructure, as well as rapid economic growth.
However, as the below table shows, Hong Kong has not been a major contributor to this success story over the past decade. While trial numbers on the mainland soared by 285 percent between 2015 and 2021, they actually reduced by 22 percent in Hong Kong. This is despite the city’s strong clinical research fundamentals, including world-class experts and scientific and research excellence; a unified, standardised system of health records that spans all Hospital Authority (HA) hospitals; and increasing collaboration with the Greater Bay Area (GBA) and its 86 million-strong population, potentially leading to recognition of local trials in China.
As covered in our 2023 report on Hong Kong and the GBA, Hong Kong has had two Phase I clinical trial centres [the University of Hong Kong Clinical Trials Centre (HKU-CTC) and the Clinical Research Management Office at the Chinese University of Hong Kong (CUHK CRMO)] for about a decade but has thus far lacked a unified approach to attracting and conducting trials.
CTI: A Potential Gamechanger?
This is set to change with the creation of the GBA International Clinical Trial Institute (CTI). Announced in October 2023 in a policy address by Hong Kong Chief Executive John Lee, the CTI aims to enhance clinical research in Hong Kong by providing a dedicated platform for conducting trials and advancing biomedical research and development. It will also harmonise work across the existing 42 hospitals in Hong Kong, making them more suitable clinical trial locations. The CTI takes inspiration from other territories that have established a single entry point for clinical trials – notably Denmark’s ‘Trial Nation’ initiative – and now punch above their weight in terms of attracting quality trials on a per capita basis.
Located in the very north of Hong Kong and hoping to bring in patients and clinicians from both sides of the border, the establishment of the CTI is part of a broader initiative by the Hong Kong government to promote biomedical research, development, and drug registration, as well as establish the territory as an ‘innovation and technology’ hub.
Secretary for Health Professor Lo Chung Mau explains the problem that he hopes this new institution will solve. “Currently, clinical trials in Hong Kong are managed in a fragmented manner by institutions like the HKU-CTC and CUHK CRMO with limited scale and impact,” he begins. “Our goal is to coordinate on a much larger scale, leveraging the 86 million population in the GBA.”
Henry Yau, HKU-CTC’s managing director, adds that “the government identified the need to streamline the entire ecosystem for biotechnology and biomedical development. This includes promoting clinical research to facilitate the translation of research findings into practical applications. To attract companies to conduct clinical trials in Hong Kong, it’s essential to streamline the registration and marketing authorisation processes.”
Yau continues, “Hong Kong’s small market size necessitates connecting its biomedical ecosystem with the larger market in Mainland China, particularly the GBA. By tapping into the GBA market, the government aims to create more opportunities for growth and innovation.”
For the multinational trial sponsors located in Hong Kong, this represents a massive opportunity. “We aim to develop an entire GBA R&D network and are now focusing on the implementation steps,” exclaims Sabrina Chan, senior executive director of the Hong Kong Association of the Pharmaceutical Industry (HKAPI). “One of the key advantages of this initiative is the ability to conduct larger-scale trials, particularly in areas like nasopharyngeal carcinoma, hepatitis B, and infectious diseases, where the GBA offers a significantly larger pool of patients. Additionally, the presence of renowned principal investigators and hospitals adds to the credibility and expertise of the trials conducted in this region.”
Countering Scepticism
All top-down, state-led initiatives of this sort are the subject of uncertainty, with some wondering whether the CTI will simply represent another layer of bureaucracy and add to the system’s complexity rather than diminish it. Secretary for Health Lo rebuffs these concerns, countering that “When the government initiates a project, scepticism from vested interests is natural. However, our role is to coordinate and facilitate, not impose.”
The HKU-CTC’s Yau adds that the CTI will be able to plug gaps that a single centre like his cannot. “HKU-CTC has been active for 25 years and has made significant contributions to academic research,” he states. “However, being part of a university’s academic research centre means there are limitations to what we can achieve. This is where the CTI comes into play. The CTI represents the government and has the authority to engage with various stakeholders, such as the HA, more effectively.”
While the HA was previously focused almost solely on providing clinical services and not particularly supportive of research, Yau has already sensed a sea-change. “With the government’s directive to prioritize research, there’s been a noticeable shift in attitude to research in the HA. Even though the CTI is not yet fully operational, we’re seeing increased interest and engagement from the HA in supporting clinical research efforts.”
However, Yau cautions that “Moving forward, the key is collaboration while avoiding duplication. We recognize the value of the existing infrastructure and services provided by both the new CTI and the existing HKU-CTC. By working together, we can ensure that resources are utilised efficiently and that the overall ecosystem for clinical research in Hong Kong is strengthened.”
Talent, Training & Travel
Other leading lights in Hong Kong’s biomedical research community have their own, more mundane, worries about the CTI project. “Personally, I see the practicality of placing a high-end medical centre at the border as a significant concern,” says Dr Tony Mok, one of Asia’s most prominent oncologists and chair of the clinical oncology department at CUHK.
“For instance, it is hard to imagine commuting to the border of Hong Kong daily for work. Those planning the new institute need to consider who will actually be willing to work there if it is to become a top-tier centre.” He adds, “Conducting clinical trials cannot be a full-time job for physicians and we already have demanding schedules, so adding travel time to the border is impractical.”
These demanding schedules have pushed more of Hong Kong’s practising physicians away from research, as leading CUHK neurologist Lawrence Wong notes. “As clinical practices have become busier, there has been a division between academic and service roles,” says Wong. “This split has made conducting clinical trials more challenging because the service side focuses on patient care, while only the academic side is dedicated to research.”
Concerns about healthcare professionals lacking the time, motivation, and expertise to dedicate themselves to clinical research on top of their other responsibilities are not unique to Hong Kong. The world over, doctor shortages have left healthcare systems stretched paper-thin with diminished clinical research capacities.
“As in other clinical trial hotspots like Korea, the UK and Europe, we have a significant shortage of doctors here in Hong Kong, meaning that most of us are tied up with service” says haematological oncologist Raymond Liang of the Hong Kong Sanatorium and Hospital. Dr Liang is, however, convinced of the benefits of engaging in clinical research, stating that “while finding time for research and clinical trials can be challenging, motivation is crucial. We must find the time to do it.”
Moreover, the Hong Kong government has clear plans in place to address this issue. Professor Lo describes addressing the shortage of trained personnel as “essential,” and has laid out an approach involving both local training and international recruitment, areas in which Hong Kong has a strong track record with its two leading medical schools.
Yau adds that enhancing clinician engagement in clinical trials is “pivotal,” noting that “One key strategy being rolled out involves alleviating clinicians’ administrative burden so they can focus more on research. With the CTI and the HA stepping in to manage paperwork, contracts, and finances, clinicians can redirect their limited time and energy towards research endeavours.”
He continues, “Moreover, to further empower clinicians, the HA is implementing a two-tiered support structure. Firstly, at the head office level, a dedicated team will drive policies on facilitating and supporting research. At the hospital cluster level, cluster coordination offices are being established to provide administrative assistance. These cluster coordination offices will handle logistical and administrative aspects, ensuring smoother project management across different hospital clusters. On-site clinical research coordinators (CRCs) will also be provided to assist clinicians directly with research-related tasks during patient consultations.”
One Country, Two (Clinical Trial) Systems
Then there is the broader issue of bringing together physicians and institutions from Hong Kong, which is heavily influenced by Western education and medical practices, with those from the mainland, often with a very different outlook. Neither exists in a bubble and several collaborative projects are already underway, but closer alignment and communication will be necessary to ensure the success of the CTI.
For leading urologist Jeremy Teoh, based out of CUHK, this gap can be bridged but requires “strong, high-quality partnerships.” He explains, “We provide guidance on trial design and protocol to ensure that the studies meet international standards. This collaboration helps us utilise China’s extensive caseload effectively while maintaining rigorous research standards. By nurturing these partnerships and working closely with both local and international experts, we aim to elevate our research and clinical practice on a global scale.”
Global geopolitical turbulence and heightened tensions between mainland China and the US may also, unexpectedly, provide an opportunity for Hong Kong and its research institutions. “There is still significant international interest in working with Chinese institutions due to the quality of research and innovations coming out of China, with Hong Kong re-emerging as a bridge to these opportunities, similar to its role in the 90s,” says CUHK gastroenterologist Justin Wu. “A decade or so ago, overseas institutions would directly connect with Shanghai or Beijing but they are now more hesitant and prefer approaching Hong Kong due to existing friendships and partnerships.”
Wu warns that “This is an opportunity, but we need to get equipped. For example, if there is a need for clinical trials, we must have a larger hinterland for more efficient recruitment. We should have an office in Hong Kong and a significant recruitment platform in the Greater Bay Area.”
Patient Practicalities
While Hong Kong excels in clinical expertise, its population of seven million people limits its ability to hold large scale trials, especially for niche indications. The idea of expanding this 12-fold by tapping into the GBA’s 86 million population and bringing trial patients to Hong Kong is an appetising one, but the practicalities of doing so are far from straightforward.
As Mok points out “there are two primary hurdles to bringing Chinese patients from the GBA to Hong Kong for Phase I trials. The first is integrating them into the HA system as most trials are conducted in academic units within HA hospitals, and healthcare charges are typically itemised, which creates a lot of extra work.” Mok has proposed creating a package price for patients from China, simplifying the billing process and reducing paperwork, but this is still yet to be agreed by the HA and trial sponsors.
He continues, “The second hurdle is immigration. Chinese patients coming to Hong Kong usually get a seven-day visa, but clinical trials often require longer stays, meaning that immigration needs to grant special visas, requiring a cumbersome application process.”
CUHK’s Justin Wu underlines countering the issue of travel restrictions in bolstering Hong Kong’s research hub push and calls for greater mainland collaboration to do so. “If we want to develop expertise, we need more patients with specific conditions and build ourselves as referral centres,” says Wu. “I focus on functional GI disorders, and there are not too many super-specialists in this area in mainland China. As a result, I receive many consultation requests from China, but it is challenging for these patients to come to Hong Kong due to permit restrictions. Therefore, if we want to develop more super specialist statuses, we need a mainland platform to see these patients regularly.”
Drilling Down on Data
Finally, there are issues around data: both in terms of accessing the wealth of data held by the Hong Kong HA for clinical trial subject identification and trial design, as well as the challenges of integrating data sources from two different medical systems on either side of the border.
Data generation is traditionally an area in which Hong Kong has excelled, as Juliana Chan – one of Asia’s leading endocrinologists and the founding of GemVCare, a company that provides data on diabetes prevention, diagnosis, and treatment based on genetic profiling – lays out. “Using databases gathered over 30 years during clinical practice with ethical approval, patient consent and hundreds of millions of dollars of research funds, CUHK researchers discovered biomarkers, algorithms, drug targets, and outcome models,” says Chan. “They then translated them into diagnostic tools and digital solutions to bring precision medicine to practice with ongoing research to develop novel drug targets.”
The territory remains in a strong position thanks to its system of electronic medical records (EMRs) within the HA. “With our publicly subsidised healthcare system, Hong Kong is in an excellent position to leverage EMR to identify individuals for various trials,” notes Chan. “This allows us to design trials in a more pragmatic and cost-effective manner, which is a significant strength for Hong Kong.”
However, accessing this wealth of data, especially for potential industry sponsors, has not always been straightforward. HKAPI’s Sabrina Chan notes that there has been some progress in making HA data more available for clinical trials, but that this process could be improved. “One important step was Hong Kong Science and Technology Parks Corporation (HKSTP) and the HA launching the HKSTP HA Data Collaboration Laboratory (HADCL) with direct access to around 200,000 patients’ anonymous clinical data from HA’s database for non-academic research and development purposes,” she outlines. “However, questions remain about whether this is sufficient and the flexibility of the current system. We are calling for a more expedited and inclusive approach to accessing this valuable data, drawing inspiration from other countries’ models.”
Secretary for Health Lo is keen to underline that data is at the heart of the Hong Kong government’s strategy to create a GBA clinical trials hub. “Some critical elements of facilitating clinical trials require government involvement to function effectively,” says Lo. “Firstly, we need to manage the cross-border movement of biosamples and clinical data, which requires effective coordination with the Shenzhen government and the Central People’s Government.”
He continues, “We will establish central data banks, biobanks, and possibly core laboratory facilities in the Hetao cooperation zone [an area straddling the boundary between Shenzhen and Hong Kong consisting of 3km2 on the Shenzhen side and 0.87km2 in Hong Kong – Ed.], helping ensure the security and standardisation of data and samples. Additionally, we are implementing a centralised institutional committee review board for the 43 public hospitals managed by the HA in Hong Kong to facilitate single application and single approval of cross-cluster clinical research.”
Lo concludes, “With one protocol, one data bank, and one computer system, researchers will be able to access the necessary data to prepare protocols and plan new studies. This integration will allow drug companies to access demographic and patient data, facilitating the planning and execution of clinical trials. This centralised system is already being piloted with the science park, providing a robust framework for future clinical trials.”
Best of Both Worlds
The advantages of closer clinical research ties between Hong Kong and the mainland are clear. At the most basic level, a wider group of patients would be able to access cutting edge treatment that they otherwise would have missed out on. In the process, this raises the level of exposure to new therapies among the region’s physicians and boosts its investment prospects – including from multinational pharma and medtech – in the process. A centralised one-stop-shop like the CTI could help smooth this process and counter some – but not all – of the several challenges to greater clinical trial integration outlined above. All of this is taking place within the wider context of Hong Kong’s repositioning as an innovation and technology hub and a distinct, but important, part of China’s broader economic planning.
Secretary Lo sums up the project’s prospects thusly: “Leveraging Hong Kong’s resources and the larger patient base in the GBA, we can significantly enhance R&D efforts. Rare diseases, for example, are never rare in mainland China as the large population means more cases to study and treat, creating a goldmine for research, education, and training. The advancements in healthcare infrastructure and policy support better diagnosis and treatment, offering a robust environment for clinical trials and biomedical innovation.”
He finishes, “in Mainland China, the government’s zero-markup policy on medicines has shifted focus towards evidence-based healthcare. This environment is conducive to high-quality clinical trials and the development of new diagnostics and therapies. By integrating Hong Kong’s high standards with the patient volume in the GBA, we can create a thriving ecosystem for biomedical innovation, benefiting both researchers and patients.” Whether this can be fully achieved remains to be seen, but many of the fundamentals seem already to be in place.
