The Asia-Pacific (APAC) region now ranks first in the world for total number of active oncology clinical trials, with China alone accounting for more than half of those studies.1 To take advantage of the potential benefits of conducting clinical research in APAC countries, sponsors need to understand the nuances of designing and operationalizing studies in these countries.
In this blog post, we explore the advantages of conducting oncology clinical trials in the APAC region and share strategies to help ensure study success.
Why consider APAC for oncology studies
Focusing on the APAC region for clinical trials comes with various advantages:
- Lower cost. Compared to the U.S. and Western countries, the cost per patient across clinical trial phases and therapeutics may be up to 40 percent lower in APAC.1,2 In Australia, the cost difference is not as pronounced but the national government offers tax offsets of up to 45 percent for eligible companies.
- Less competition. With its large patient population and lower volume of studies, the APAC region has a lower trial density, leading to less competition for eligible patients. For rare cancer and biomarker-driven clinical trials, this can facilitate recruitment.
- Diversity. Regulatory authorities are emphasizing clinical trial diversity to ensure the broadest possible access to novel therapies. The APAC region offers cross-genealogical populations, allowing sponsors to collect a broad spectrum of data that includes rural residents and groups that have traditionally been underrepresented in clinical research.3
By conducting clinical trials in APAC countries, sponsors also have the opportunity to help close the diversity gap in genomic data. According to a 2009 analysis, 96 percent of participants in genome-wide association studies were of European descent. Today, many APAC countries, including China, Japan, and South Korea, have established genomic screening initiatives to identify oncogenic drivers and potential therapeutic and diagnostic targets. - Risk management and decentralization. The COVID-19 pandemic unmasked vulnerabilities in the existing approach and infrastructure for clinical trials. Diversification of sites and decentralization of studies may be an effective strategy for ensuring study continuity across a range of unexpected circumstances. The APAC region is positioned to be a frontier for decentralized clinical trials (DCTs) given their high mobile phone use, internet availability, and openness to adopting new technology. Many APAC countries are already well-versed in digital health and health technologies such as electronic medical records, electronic data capture, and telehealth. The regulatory landscape for DCTs is still being defined, however, and sponsors will need to stay abreast of evolving regulations.
How to plan for clinical trial success in APAC countries
Sponsors who are considering the APAC region will need to incorporate the following into their planning:
- Local market knowledge. Understanding the local market is paramount as differences in language, culture, and belief systems may impact how clinical trials are perceived or conducted. Study protocols may need to be localized and adapted based on standard of care and other norms. Given the complex healthcare landscape across the region, local market knowledge also includes insight on how market access differs among countries.4
- Standard of care reimbursement policies. While standard of care in clinical trials is usually reimbursed by the payer in the U.S., EU, and Australia, it is often the responsibility of the sponsor in the APAC region. Understanding the reimbursement for standard of care in each country where a study will be conducted is critical for building those costs into the trial budget.
- Transportation and logistics. Transportation may be an issue, whether it is scarcity in the emerging markets or traffic congestion in metropolitan areas.5 This may impact travel for study participants and transport of study materials and biospecimens. If transport is time-sensitive or cold-chain logistics are required, sponsors will need to plan for all potential scenarios.
Key takeaway
Partnering with a CRO who has local knowledge and deep relationships with investigators, sites, and key opinion leaders can help sponsors plan for study success in APAC countries. To learn more about expanding your global cancer study to include APAC countries, download our white paper, Making the Asia-Pacific Region a Destination of Choice for Oncology Clinical Trials.
[1] Clinical Trials Arena. Asia-Pacific region has seen the largest growth in oncology-related trials over the past decade. Available at https://www.clinicaltrialsarena.com/analysis/asia-pacific-region-has-seen-the-largest-growth-in-oncology-related-trials-over-the-past-decade/.
[2] Clinical Leader. The Asia-Pacific Region: A Hot Spot for Clinical Trials, March 2, 2021. Available at https://www.clinicalleader.com/doc/the-asia-pacific-region-a-hot-spot-for-clinical-trials-0001.
[3] UICC. Estimated age-standardized incidence rates (World) in 2020, all cancers, both sexes, all ages. Available at https://www.uicc.org/news/globocan-2020-new-global-cancer-data.
[4] L.E.K. Expanding Into Asia Pacific: Life sciences opportunities and strategies for success. Available at https://www.lek.com/sites/default/files/insights/pdf-attachments/Expanding-into-Asia-Pacific-v2.pdf.
[5] Frost & Sullivan. Asia: Preferred Destination for Clinical Trials. Available at https://novotech-cro.com/sites/default/files/170217_FrostSullivan_Asia%20white%20paper_full.pdf.