Clinical Trials In APAC: Challenges And Opportunities
By Ed Miseta, Chief Editor, Clinical Leader
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For several years, the APAC region has been one of the hottest growth regions for clinical trials. In June 2022, I had the opportunity to sit down with Brad Miller, Clinical Operations Director at Biosceptre; Sarah Lieber, VP and head of North America Regulatory Affairs and global labeling at Sanofi; and Michael W. Young, Principal and Founder at biomedwoRx: Life Sciences Consulting. These experts were able to discuss the growth of trials in the APAC region, the opportunities presented to sponsor companies, and the challenges that still exist. This Q&A summarizes some of the questions addressed during the webinar.
Ed Miseta: What factors are driving the growth of clinical trials in the APAC region?
Sarah Lieber: From a regulatory perspective, part of the reason for conducting trials in a certain region is gaining registration and market access in those countries. Some countries, such as Japan, Korea, and China, do require local clinical data. In APAC regions I believe sponsors also expect to see high-quality data coming out of those trials. Other companies are simply interested in global drug development.
We can also look at this from the patient perspective. Companies conducting trials want to go to countries where the patient populations are located. That is especially true now that clinical trial diversity is a concern across the industry. I would also note that the regulatory process in China is quite dynamic and evolving. It used to take a lot longer to have a CTA approved in China. That has changed and the process is now much more streamlined.
Miseta: Michael, would you like to share some thoughts on the reasons for the growth of trials in this region?
Michael Young: When we talk about patients, one of the things you need to look at in the APAC region is the sheer number of potential trial participants. If you take the People's Republic of China, for example, that one country represents about 20% of the entire world's population. That population is around 1.5 billion people. Then you can add to that the fact that China and Japan represent the second and third largest pharmaceutical markets in the world. Finally, we can look at this from the standpoint of disease prevalence, diet, and lifestyle. APAC countries have seen an explosion in certain cancers and tumor types. For those reasons, the Asian population really represents a significant opportunity for clinical trials.
Miseta: Trials require the expertise of qualified CROs. The APAC CRO market was valued at $7.6 billion in 2021 and is forecast to reach $25 billion by 2025. Additionally, all top 10 global CROs have a presence in the region. How big a factor is that for companies wanting to conduct trials in that region?
Brad Miller: That’s an interesting question. In my prior experience of looking for CRO partners, the presence of global CROs in a region was not something of huge importance to me. One of the reasons is we knew who most of the players were within the Australian market. If I was entering a country where I did not know many of the regional CROs, then having the name recognition of a global CRO would be more important. I would have more confidence in their stability, size, and experience.
Any time you’re conducting a multi-country or a multi-jurisdictional study, having access to a global CRO with staff on the ground is going to be vitally important. Still, I would add there are great people working at smaller and mid-sized CROs as well. Those smaller CROs may specialize in certain regions, indications, or modalities of treatment and should not be overlooked. One example within the APAC region is a company called Novotech. I have never worked with them, but I know from their branding that they focus on trials in the APAC region. My advice is to focus on a CRO that is a good cultural fit for your company and can deliver the services you need.
Miseta: Sarah, is the growth of trials in the APAC region helping to drive the growth of competent CROs in that area as well?
Lieber: I think so. CROs are responsible for the outcome of clinical trials and the conduct of trials from the GCP perspective. The ability of CROs to deliver quality data and bring products to market is also of great importance to the regulatory authorities. The need for quality data drives the need for quality CROs that can operate in those environments. CROs are also instrumental in helping sponsor companies know the culture, standards, and language of the countries in which they operate.
Young: I would add there are also differences in standards of care across countries. For instance, in Taiwan, Japan, China, India, and Singapore, sponsors are expected to pay for the standard of care with very few exceptions. When it comes to the construct of trials, it's important to have a clear, on the ground understanding of what you're going to be up against and the impact it will have on your budget.
Lieber: Before we conduct a clinical study in any country, we will have a regulatory consultation. We will discuss the standard of care, protocol design, endpoint design, and more. The CRO in any region will generally have regulatory capabilities and understand the local regulatory environment. They can help guide you through designing a great study and then executing it. We often think CROs simply conduct the research, but they play an important role in the regulatory development strategy in any country.
Miseta: One of the factors cited for spurring the growth of trials in the APAC region is lower costs. Some estimates place the trial costs at 30% to 40% less than in the U.S. and Europe. Brad, can sponsors expect to see those cost savings in Australia?
Miller: In Australia we have an R&D tax incentive program that provides up to a 43.5% refundable R&D tax offset of eligible R&D expenditures. If you have less than 20 million in turnover, you get that back in cash at the end of the financial year. If you have more than 20 million in turnover, then it's a non-refundable amount that offsets future taxes. Like all government schemes, there are requirements that need to be met, including that the eligible R&D activity is undertaken in Australia. That's one of the primary reasons why companies should be looking to Australia to undertake their clinical trials.
There are other steps that need to be completed to access this R&D credit. The first is the preparation of an annual report, which is lodged with AusIndustry. AusIndustry is an Australian government body which confirms that the R&D undertaken is eligible for the tax breaks. Once you've received the all-clear, information regarding your actual R&D expenditure is processed in your tax return. We have seen that the cost in Australia is about 30% to 40% less than the U.S., and that pretty much spans the entire process from central labs to hospital and doctor costs. This tax incentive has been around for about 10 years and is something the Australian government has continued to support. I expect it will exist for the foreseeable future.
Miseta: Michael, what are your thoughts on clinical costs in the APAC region?
Young: The FTE rates in China are highly competitive, but most experts that I talk to in the region report that the real differences are found in the actual trial costs of data management, biostatistics, some of the lab testing, and the bioanalytics. The streamlining of the processes, and the alignment with what the rest of the world is doing, has allowed sponsors to be able to avoid having to replicate the same trial.
Still, I believe we have seen a dramatic change over the last five years or so. Asia is recognizing that they are now very much mainstream in a lot of the activities they do. By and large, you're starting to see a lot more cost efficiencies come into play. That along with the lower FTE rates makes this a very attractive and cost-effective approach.
Miseta: Do you expect those cost differences to disappear at some point?
Young: Over the next few years I fully expect the cost of doing trials in Asia will more closely replicate what you're seeing around the world.
Miller: I agree. I think there are CROs in the region that are centralizing their support services. Although the major CROs have a presence in Australia, much of their presence is related to project management and monitoring. It has not been related to data management or statistics, which they are trying to centralize in lower-cost regions. When Australia does become more expensive, and it certainly is becoming more expensive as time goes by, CROs will keep costs down by using a centralized model where some of those services are provided in regions with a lower cost of living.
Miseta: A couple of registrants asked about timelines required to start a clinical trial in China and Japan. Sarah, is that something you can discuss?
Lieber: I will start with Japan because of their clinical notification timeline. It has been quite established and routine, which is a 30-day notification. If you provide the documentation, within 30 days agents will come back to you regarding whether you can proceed with the trial. One unique thing about Japan that is different from the FDA is the chemistry, manufacturing, and controls (CMC). The CMC information is relatively light. That's why it's more of a clinical trial notification rather than clinical trial application, or IND that you would think of in the U.S. or EU.
In China the timeline has evolved significantly. A few years back, the clinical trial application process might have taken a year or more for a complex biologic. Regulatory reforms have reduced that time to 60 days, which is a remarkable difference. That has made China much more attractive. The amount of CMC information required makes it similar to that required in the U.S. or the EU.
Please click here to see the entire Clinical Leader Live webinar on conducting trials in the APAC region.