5 Reasons Why APAC Leads The World In Clinical Trials
By Life Science Connect Editorial Staff
The Asia-Pacific (APAC) region has quickly become the leading market for clinical trials. Home to 60% of the world's population, this area offers many advantages to pharmaceutical and biotech companies from other countries looking to expand their clinical trial locations, including low costs, a friendly regulatory environment, and low trial density. The CRO market is also proliferating, offering companies numerous research partnership opportunities. In 2021, the APAC CRO market was valued at $7.6 billion, but it is predicted to expand to $12 billion by 2025.
Clinical Leader Live turned to experts Sarah Lieber, VP and head of North American regulatory affairs at Sanofi, Brad Miller, clinical operations director for Biosceptre International, and Michael Young, principal for biomedwoRx Life Sciences Consulting, for insights on conducting clinical trials in the APAC market. They discussed growth factors driving clinical trials in APAC, cost savings initiatives, clinical trial timelines, CRO availability, and data quality.
APAC Offers More Than Just A Large Population
The APAC region's 4.3 billion residents aren't the only reason why it's become a popular destination for clinical trials. First, many countries, including Japan, Korea, and China, require local data for drug approval. Conducting these trials locally allows companies to seek approval in APAC countries while also providing data for U.S. and European drug approval applications. Secondly, this region has many countries with well-established medical infrastructures and streamlined application processes. Also, the data from these trials is known to be high quality, making it easier to seek approval in other markets as well. Finally, conducting global clinical trials improves participant diversity, which is especially appealing to U.S. companies concerned with meeting the FDA's new requirements.
Australia Incentivizes R&D
Conducting clinical trials in the APAC region can be more cost-effective than in the U.S. and Europe. One nation that is actively working to reduce costs is Australia, whose Research and Development Tax Incentive (R&DTI) scheme encourages innovation and growth. This program offers a tax offset for eligible R&D activities conducted after July 1, 2021, as long as they meet specific criteria. Companies with an aggregated turnover of under 20 million Australian dollars can receive a refundable tax offset at 18.5 points above the corporate tax rate. However, the amount is reduced if a company doesn't have tax liability. Companies above the A$20 million cutoff pay a non-refundable sum that balances their future tax liability.
"With these incentives and other factors, in Australia, the total cost of running a clinical trial is about 30%-40% less than in the U.S.," added Miller. "The government wants Australia to have a vibrant life sciences industry, including increasing clinical trials."
Japan And China Offer Streamlined Trial Approval Processes
Companies interested in conducting research in APAC countries may wonder how long it takes to gain regulatory approval to initiate their investigation. The answer varies by country, but multiple APAC nations offer business-friendly processes. For example, Japan and China have differing approval methods, but both have made vast improvements in recent years to encourage innovation.
In Japan, the Clinical Trials Act of 2018 created a streamlined and time-saving approval process. First, companies obtain Institutional Review Board (IRB) approval, which typically takes four to eight weeks. Next, they submit an application to the Pharmaceuticals and Medical Devices Agency (PMDA), which responds within 30 days. The quick turnaround makes this nation the second-fasted country for clinical trial approval. Despite having fewer regulations than the U.S., Japan still has high standards for ethics that align with those in the U.S. and Europe. For these reasons, Japan is quickly becoming a leader in clinical trials.
China has also made great strides to increase efficiency in its approval process. Regulatory reforms have reduced the approval timeline from years to months. Companies complete a Clinical Trial Application (CTA) that demonstrates their trials will follow all drug laws and regulations and meet China's ethical standards. Once a company has submitted its CTA to the National Medical Products Administration (NMPA), it can expect to receive notification within 60 business days. The application is automatically approved if the company has not received a response in that timeframe. However, the trial must be carried out within three years of approval, and if it fails to recruit participants within that time period, it loses approval.
"APAC is a fertile area for global trials for new drug entities that will enter the U.S., Europe, or Latin America market," commented Young. "As APAC trials improve in reliability and efficiency, it's become more and more attractive for many indication types."
Top CROs Work In APAC Countries
Almost every pharmaceutical or biotech company relies on CROs to assist with the drug development process, and the APAC landscape is no different. In fact, the top 10 global CROs have a presence in the APAC market, making it easy to find a knowledgeable partner well-versed in local regulations. Additionally, using global CROs helps companies navigate multiple markets' varying standards of care and drug approval processes.
"Often, we think of CROs as only companies that help conduct research, but they're also instrumental in building regulatory development strategies in each country and liaising with local health authorities," explained Lieber. "From the standard care protocol to the endpoint design, CROs have regulatory capabilities and can guide companies through designing and executing a great study."
Quality Data Is Easy To Obtain
Many APAC countries have high standards for data quality that translate well to other markets. For example, several universities in Korea have robust digital data capture methodologies that go beyond what companies usually collect in clinical trials and forms. Other countries in the region are also advancing new data capture techniques that are on the leading edge of technology.
"If a company has a good protocol and a monitoring plan with CRO or clinical oversight, then the data it collects in their APAC region clinical trials will be more than sufficient for other countries," advised Lieber. "I haven't encountered any problems with data quality in my experience working in global markets."
Lieber further advises companies who want to gather data in the region to investigate local regulations before deciding which clinical trial phases to conduct in an APAC country. For example, China requires local population data for Phase 1 trials before approving subsequent phases. However, they may be willing to accept Phase 1 results on ethnically Chinese patients living in other countries, such as the U.S. or Europe. Japan, however, will only look at Phase 1 data in non-ethnically Japanese participants if the company can demonstrate that ethnic differences do not affect the study's modality. In this situation, the company could consult with the PDMA and commit to collecting additional data while conducting Phase 2 or even Phase 3 trials as a sub-study. These country-specific differences demonstrate the importance of working closely with local health authorities throughout planning and implementation.
Conclusion
The APAC region is leading the way in the competitive global drug development market. Its large, diverse patient population, low costs, ease of regulatory compliance, CRO presence, and innovative data capture methods all contribute to its success in the clinical trial landscape. In addition to these factors, the APAC region's regulatory bodies promote a high standard of care that meets international expectations for ethical protocols. In the last decade, clinical trials in the region have grown dramatically faster than in the U.S. and Europe. Given these advantages, it's easy to see why.