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APAC Clinical Trials: Is Decentralized the Next Frontier?

Rapid growth in the Asia-Pacific clinical trials (APAC clinical trials) market has created strong opportunities for conducting decentralized clinical trials in the region, especially for North American sponsors looking for diverse and tech-savvy patient populations. A recent survey conducted by IQVIA shows participants are ready for the virtual transformation with 89% of patients at a West China Hospital citing decentralized trials as an acceptable option for research. That same survey found 98% of patients approve of the inclusion of electronic diaries, 96% approve of digital devices and 90% approve of telehealth visits as part of clinical trials.

Sponsors and CROs should get ahead of the curve by exploring the region’s strategic landscape for virtual clinical trials and research.

The Appeal of APAC for Clinical Trials

APAC’s participant pool is a key factor in its appeal for clinical research:

· Large population: Asia accounts for 60% of the global population, including a large urban population of more than 2.3 billion people.

· Diverse ethnicities and geographies: With access to cross-genealogical populations, sponsors can gather a broad spectrum of data, including people from traditionally underrepresented groups, as well as rural residents.

· Treatment-naïve population: APAC residents are likelier to be treatment-naïve for certain health conditions, so they’re prime candidates for new treatments.

· Similar disease patterns: Health conditions present similarly in APAC residents and Westerners, allowing sponsors to identify meaningful, relevant outcomes.

· Technology adoption: APAC consumers and industry leaders are known to embrace innovation. McKinsey notes Asia’s “rapid emergence as a global technological leader.” APAC’s adoption of digital health and health tech, including telehealth, electronic medical records and electronic data capture, bodes well for DCT adoption in the region.

· Growing “pharmerging” market: Asia is the fastest-growing global market for medicine sales. Countries such as China and the Philippines are “pharmerging” markets with significant potential for growth. IQVIA notes that growth in global medicine spending will be lifted by stronger “pharmerging” market growth through 2025.

Operational Advantages of Conducting Clinical Trials in APAC

Along with a strong participant pool, APAC offers business advantages for sponsors and CROs:

· Cost savings: Conducting trials in APAC can often be more cost-effective. Skilled talent is usually available at a lower cost, compared to hiring in the West. Countries such as Australia offer tax credits to incentivize clinical research and therapeutic development. And of course, the currency exchange is often favorable for Western sponsors.

· Lower trial density: APAC’s large patient population and its lower volume of studies overall create a lower trial density and smaller risk of competing trials. For example, the number of recruiting sites for non-Hodgkin lymphoma trials per million urban residents is 3.8 in the United States and 0.4 in APAC. And for T-cell lymphoma clinical trials, the trial density in APAC is about four times lower than in the United States.

· Efficiencies in recruitment and retention: APAC often witnesses faster enrollment periods and competitive recruitment rates when compared to the United States. For instance, the enrollment duration in months for non-Hodgkin lymphoma studies is 25.5 months in the United States and 23.1 in APAC. The monthly recruitment rate for enrollment at a given site each month, is 0.2 in the United States and 0.4 in APAC.

It’s important to note that faster, more efficient trials shouldn’t require compromises in quality. APAC has equivalent quality standards for clinical research, and countries in the region continue to improve at several levels:

· Protections for intellectual property

· Regulatory efficiencies, through initiatives such as the International Conference on Harmonization and Australia’s Clinical Trial Notification program

· Bases of key opinion leaders, such as academic researchers, to influence trial participation

All these factors are driving rapid growth in clinical research in APAC across many disease states. As just one example, biopharma companies have initiated over 800 trials in non-Hodgkin lymphoma since 2018, and more than 40% involved the Asia-Pacific region. China, Australia and South Korea were the most frequently involved countries.

Challenges with Clinical Trials for APAC CROs

With such a promising landscape, why hasn’t the industry seen an explosive growth in decentralized trials in APAC? Sponsors and CROs have faced hurdles in:

· Working with regulators: Despite improvements in the regulatory environment, sponsors need to tap into local expertise to successfully navigate this arena, especially since requirements vary across the region.

· Cross-cultural barriers: Language and cultural differences can pose a challenge to sponsors. For example, many Asians traditionally rely on their primary care physician’s guidance and may hesitate to enroll in a trial without it. Sponsors can address this issue by integrating telehealth into virtual trials, fostering relationships with local providers and working with an industry partner that has a local presence.

· Perceptions of DCTs: APAC is known for innovation, but misconceptions about DCTs persist. Some APAC-based sponsors view DCTs as inferior to traditional, site-based trials, which may help explain why they haven’t yet been widely embraced. However, participants don’t necessarily share these opinions. As noted earlier, nearly 90% of patients at a West China Hospital reported on a recent survey they would welcome decentralized clinical trials.

Local Partnerships: The Missing Link for Asia Pacific Clinical Trials

Despite the challenges, the outlook for clinical research in APAC—and specifically decentralized trials—has never been brighter. Amid the region’s rapid evolution, one constant is the need for a presence on the ground. Local knowledge and relationships are key to operating successfully in APAC, even for virtual trials.

In recognition of this potential, ObvioHealth and Novotech ( the fastest growing CRO in APAC) have formed a strategic partnership to fill a gap for sponsors that want to conduct DCTs in APAC. Novotech enables regional insight and operations with 29 local offices. As an experienced clinical research organization, ObvioHealth brings DCT expertise, with a track record of successful trials around the world.

ObvioHealth has recently completed or is currently conducting trials in Australia, New Zealand, Indonesia, Bangladesh, Malaysia, the Philippines, Singapore and Thailand covering therapeutic areas such as allergy, behavioral health, gastroenterology, mental health, nutrition, oncology and pain management.

“APAC has become an opportunity market for clinical research,” says Erin Haumann, managing director of APAC for ObvioHealth. “Decentralized trials offer the opportunity to register products in multiple large and growing markets without significantly extending timelines, enabling sponsors to reduce time to market by much as several months.”

Together, ObvioHealth and Novotech are helping sponsors unlock the potential for DCTs in APAC—allowing them to conduct cost-effective studies, identify meaningful outcomes and advance innovation.