The island’s effective management of the pandemic has helped boost its attractiveness as a destination for international healthcare companies to conduct clinical trials of new drugs. But to remain competitive post-COVID, Taiwan may need to take some additional steps.
Within the global healthcare industry, one of the areas in which the COVID-19 pandemic has had a pronounced effect has been the submission and execution of clinical trials for new drugs. A study published in the journal Clinical and Translational Science last year emphasized that “the COVID-19 pandemic has also caused unmatched disruption to research and clinical trials worldwide and has hindered the ability [of organizations to conduct] these trials effectively and safely.” In addition, the report noted, “social distancing and lockdowns that aimed to reduce the spread of the virus have also challenged the recruitment and [administration] of clinical trials.”
Researchers at Taiwan’s semi-official Center for Drug Evaluation (CDE) further found that, based on a preliminary analysis of data from the U.S.-based clinical studies registration portal ClinicalTrials.gov, the number of non-COVID-related clinical trials submitted globally in 2020 decreased by around 21%. The most heavily impacted regions included the U.S. with a 24% decrease, and Europe, where the number of trials submitted dropped by around 26%.
Meanwhile, Asia – where some countries were relatively less impacted by the initial outbreak of COVID-19 – saw a 7.1% increase in clinical trial application submissions. The CDE’s own database of trials registered in Taiwan shows an impressive jump of around 13.7% in the total number of investigational new drug applications submitted by foreign manufacturers to the Taiwan Food and Drug Administration (TFDA) in 2020. That number increased by another 10.8% last year.
Dr. Chern Herng-der. a distinguished research fellow at the CDE, puts some of these figures in perspective, noting that the U.S. database is a voluntary registration system and does not always count those countries in multi-site clinical trials that join the study at a later date. As a result, “you may not get the most accurate number… but what we do see is a trend,” he says.
Chern also notes that in the first six months of 2020, Taiwan, like most places, actually experienced a notable decrease in the number of clinical trials submitted by multinational pharmaceutical companies. He says that several companies intimated to him at the time that their headquarters were concerned that Taiwan would be hard-hit by the coronavirus given its proximity to China. They thus chose other sites to carry out their studies.
Yet Taiwan, through strict border policies, quarantine requirements, contact tracing, and other well-implemented pandemic measures, managed to avoid the brunt of COVID-19, allowing life to mostly go on as normal. This included the ability of hospitals and medical centers to continue their research and development efforts without being inundated with patients suffering from COVID symptoms. Chern says that clinical trials consequently made a big comeback in the second half of 2020.
Adding some context to these numbers, Cindy Chou, a healthcare industry professional, says that the main benefit Taiwan had throughout this period was the ability to continuously enroll patients in clinical studies. Chou, who co-leads the Clinical Research task force for the International Researchbased Pharmaceutical Manufacturers Association’s (IRPMA) Medical & Regulatory Affairs Committee, also notes that prior to COVID, some multinationals chose not to trial certain drugs in Taiwan or other Asian countries because these locations did not fit what they saw as their target patient population.
“But during COVID, they had no choice; they had to come to Asia, to Taiwan,” she says. “I think that opened the door for us and we showed them that” Taiwan is a suitable destination for conducting trials for such drugs. “Now, they have confidence” in Taiwan, she adds.
Chern of the CDE also notes that Taiwan’s relatively good performance in clinical trials during COVID may have had something to do with it being part of the “second wave” of sites included in certain global clinical studies, particularly in cases where one or more of those in the “first wave” encountered issues with patient recruitment. He says that this supposition makes sense because “Taiwan belongs to the so-called ‘Chinese ethnic group,’ so if China shuts down, these companies will very often come to Taiwan.”
In previous years, Taiwan had faced stiff competition from regional neighbors like China and Australia in attracting clinical trials from overseas. However, the advent of COVID-19 has changed the playing field, at least temporarily. Chern says that China’s decision to approve only its domestically made COVID vaccines, which have a lower efficacy than the four major vaccines produced by multinational firms, could put it at a further disadvantage, especially considering the spread of the much more transmissible Omicron variant. Beijing’s decision to completely shut down cities where outbreaks occur would make conducting clinical trials there all the more challenging.
Nevertheless, Chern predicts that sooner rather than later, the pandemic situation for most countries will start to normalize, and Taiwan may find itself behind the times when that occurs. He and Chou of IRPMA point out that other Asia-Pacific countries, including China, have adjusted regulations related to medical R&D since the beginning of the pandemic in order to enable clinical trials to proceed unhindered. Such changes include shipping trial drugs directly to patients and conducting remote or virtual check-ins with trial participants.
However, Taiwan’s ability to shield itself from the worst of the pandemic has presented less incentive for its health authorities to consider more flexible arrangements for conducting clinical trials, Chou says. She therefore says she doesn’t expect more companies to choose Taiwan for their clinical trials in the short term. “In the long term, it really depends on whether the government can sense the urgency of making those regulatory or environmental changes in Taiwan” in order to keep up with the other countries.
For his part, Chern says that Taiwan can learn from the positive experience of those who have implemented more extensive regulatory changes. “Of course, the bottom line is that quality cannot be compromised, but if Taiwan can ensure that, it can match those international trends and attract more trials to take place in Taiwan,” he says.
Getting a head start
Besides regulatory reforms, how can Taiwan start to leverage its strengths in medical R&D to ensure that it is still ahead of the game in clinical trials post-COVID? One way is to focus on increasing the number of early-stage studies, namely Phase I and Phase II trials. Chern says that in terms of doing simple, large studies, such as those involved in Phase III trials, China has the market cornered thanks to its massive pool of potential participants.
However, he says, “Taiwan has gone a long way in terms of building up the quality and credibility” needed for early-phase trials, in which “the principal investigator must have more intellectual input in the study design and the study may not require many patients.”
Chern says that in terms of the composition of clinical trials in Taiwan, data indicates an upward trend in the number of Phase I and Phase II trials between 2015 and 2020. Such studies constitute around 45-50% of the clinical trials taking place in Taiwan, compared to the much smaller proportion of such early-stage studies conducted in China.
On the other hand, Chou of IRPMA says that this is actually more of a global trend. “Early-stage studies are increasing for two reasons. One, of course, is the introduction of new compounds,” she says. “The second is that a lot of pharmaceutical companies are trying to shorten their development timelines, to speed up approval of their drugs to become available on the market more quickly.”
One of the more significant roadblocks Chou sees to solidifying Taiwan’s status as a hub of clinical trials in Asia is the decentralized system for managing the execution of such studies. Each part of the process, she says, is handled by a different government organ.
“For example, the clinical trial protocol is approved by the TFDA, but the importation of electronic devices needed to complete the study is controlled by the NCC [National Communications Commission], and the hospital or institution where the trial is being conducted is supervised by the Department of Medical Affairs,” she says. Such a setup tends to slow down the whole process, especially if the regulatory bodies are not completely aligned with one another. Chou suggests that Taiwan look to recent moves by the governments of South Korea and Australia to streamline the approval and execution of clinical trials, including Korea’s establishment of a semi-official organization that assists foreign manufacturers with navigating all aspects of the clinical trials process there.
Another suggestion, provided by the CDE’s Chern, is for Taiwan to sign mutual recognition agreements (MRAs) with other jurisdictions. Such agreements allow signatories to rely on drug inspections conducted by the partnering country’s health authorities and increase the efficiency of clinical trials by avoiding redundant inspections. Chern says that Taiwan’s relative lack of MRAs resulted in delays to many trials during the initial outbreak of COVID because the TFDA’s inspectors were not able to personally visit the trial sites of other countries.
Overall, both Chern and Chou argue that while Taiwan’s leaders do understand the need to make changes quickly, it’s a matter of motivating them into action. Chern says that such adjustments require top-down coordination and warns that time is of the essence.
“The landscape is getting more and more competitive, so while I think Taiwan has been performing quite well, its leading edge is gradually getting smaller,” he says. “And COVID might at any time change the game, so we might not have too much time to catch up.”