The benefit of running clinical trials in Asia- Pacific for biotech companies
The benefits of outsourcing clinical trials to a contract research organisation (CRO) have been proven time and again, with industry research showing that biotech companies are looking to avoid the trap of committing to inflexible contracts from large CROs. Because of this, there is a distinct trend towards working with specialised CRO partners, because of the deep expertise this specialisation can bring, as well as the flexibility and affordability factors.
According to Frost & Sullivan, the CRO market is forecast to grow to US$71.7billion by 2024 (+8% CAGR 19-24F). It also said the need for novel therapies and cost-effective R&D will drive growth for CROs, especially in the Asia-Pacific (APAC) region. As biopharma companies continue to externalise R&D operations with a higher focus on the Asia-Pacific region, the CRO market in the region is forecast to grow at double the global rate, at a compound annual rate of +15% percent between 2019 and 2024.
One of the reasons biopharma companies are turning to the Asia-Pacific region is that running trials in traditional locations, such as North America and Western Europe, is becoming more challenging. Increasingly a larger data set is needed, and that requires locations outside these traditional markets. This is driving a much greater focus on APAC as a destination for clinical trials.
According to GlobalData, the median number of patients recruited in oncology clinical trials involving sites in the Asia-Pacific region was over 40% higher than the global median (2018-2019 trials).
Early phase studies with high quality and speed
A US Investigational New Drug (IND) submission is not necessary to initiate first-in-human (FIH) clinical trials in Australia.
Australia and Asia have become destinations of choice for biopharma clinical trials. This is mainly because of its large patient pool, lower trial density and so lower risk of competing trials, the high quality of medical facilities, government financial incentives for clinical trials, lower costs, and the strategic importance of Asian consumer markets.
In fact, between 2017 and 2019, there was a +13% rise on average each year in clinical trials conducted in Australia.
"Biotechnology companies can initiate a clinical trial in Australia in parallel to the preparation of a US IND submission, often commencing dosing within a single review cycle of six-to-eight weeks from submission."
Dr Simone Flight, principal consultant at Novotech Biodesk
There are several other reasons why early-phase studies are heading to APAC, including:
- Increasing middle-class and aging populations, reforms and market access
- The large pool of experienced investigators: more than 2,800 Investigators in APAC have participated on a minimum of 10 trials, according to GlobalData.
- Favourable regulations, including ICH E17 and AFTA harmonisation and fast-track options
- Ease of operating trials, including high data protection and low legal barriers
One of the main advantages of choosing Australia for FIH and early-phase studies is the very quick start-up timeline. In well over 95% of trials run in Australia there is no requirement for a clinical trial application dossier, which the FDA requires for an IND in the US and similarly for a clinical trial application for the EMA.
In addition to this, the Australian government also offers up to a 43.5% refund on clinical research spend. Qualifying companies with less than $20M in annual revenue receive a cash refund at the end of the fiscal year. The rebate includes any activity (provided it's conducted in Australia) that is either directly related to, or in support of, core clinical trial activity. That includes database management, clinical trial insurance, bio-statistical analysis and recruitment costs. It helps to make Australia an optimal trial location for biopharma companies looking to accelerate their clinical development at reasonable cost.
"We've actually done four phase 1 studies in Australia, and about to start-up number 5, 6 and 7. But we went originally into Australia because of the tax credit, and then recognized both the speed and the quality of data generated from the sites and from the CROs, so we've continued to run most of our phase 1 studies in Australia. The reason we keep going back is the high quality. We would not continue to do that if we weren't really impressed with the quality of the data."
Chief Medical Officer at US biopharma
Accelerating patient recruitment for complex trials
As study protocols and designs become increasingly complex, so does patient recruitment. Asia, with its large treatment-naïve population pool and low trial concentration has become a preferred destination to accelerate subject recruitment for the most complex clinical trials. While Australia and New Zealand are preferred locations to run early-phase trials, sponsors often look to Asia for large, late-phase clinical studies.
According to GlobalData, about half of all oncology studies initiated worldwide in 2019 involved sites in Asia-Pacific and the number of oncology clinical trials in the region grew by +13% each year on average between 2017 and 2019.
Moreover, most Asian countries lack systematic reimbursement of standard of care which means clinical trials are often the only channel that patients can access novel treatments. This ultimately stimulates recruitment rates and encourages patient adherence to research therapies.
"I think the biggest difference between the APAC and, say US sites, again is really that strong engagement by the investigators and the sites in terms of enrolling the right patients for your drug based on the proposed mechanism of action"
Executive Vice President and Chief Medical Officer at US West Coast Biopharma
An alternative to global CROs for late stage trials: partnership of regional specialists
According to GlobalData, phase II and III trials represent approximately 85% of sites activated in biotech-sponsored trials. About 30% of the phase III trials are being managed across two or more geographic regions.
In an outsourced CRO model, working with a local, regional team can be the key to success. A regional CRO provides the local expertise which supports sponsors’ ability to quickly activate sites and get patients enrolled. A flat team structure also facilitates communication between the CRO and the sponsor as well as decision-making, and to accelerate escalation when issues arise.
Also, having staff located near the study site, and understanding the culture and language makes a huge difference in terms of a study’s success rate.
Regional teams offer sponsors:
- Direct cultural understanding and ease of local environment navigation
- Better patient uptake and involvement
- Direct access to senior management
- Faster timelines because of this
- Lower costs because of faster timelines
Novotech experience recommends six key criteria for successful regional alliance:
- The CROs and biotech have a successful history of working together
- The CROs have the flexibility to work with a range of programme management and communications models
- The CROs have a willingness and experience in dividing services to ensure the sponsor has access to “best of breed capabilities” and eliminate fragmentation of core central services
- A governance structure is established, including senior participants from the sponsor, and all CROs to ensure that milestones are on track and that key issues can be quickly resolved
- The CROs adopt a single set of SOPs and operational instructions
- Use of single IT systems (for example CTMS, eTMF, safety DB)
APAC’s level of site resilience during the COVID-19 crisis
According to the Cancer Research Institute’s information, 60% of oncology trials in APAC reported that they were able to continue enrolment and recruitment normally during the peak of the pandemic – as compared to 20% in the USA. This shows the high level of site resilience in the region, and also the safety and high quality medical response to a pandemic where many Western countries – including the US and UK – are considered by many to have not managed the crisis as well.
According to Frost & Sullivan, less than 8% of clinical trials running in Asia-Pacific faced disruption because of the COVID-19 crisis, while this ratio was two to three times higher in Europe and North America.
Sites across the APAC region have quickly changed how they manage trials, and most are able to deliver the clinical trial services their clients need.
The swift pandemic response and now low infection rates in the region is evidence of the high quality medical and healthcare network.
As this whitepaper has made clear, the data – both statistical and anecdotal – shows that the APAC region is in demand for clinical studies because it has both the depth of quality and the breadth of experience to deliver trial results efficiently and safely with a real focus on quality control.
APAC’s Covid-19 experience
Along with the whole region, Novotech’s Asia team had some painful experiences with SARS and MERS in 2003 and 2015. Based on lessons learned from these experience, Asian governments acted faster and stronger than others when Covid-19 hit. The public's awareness of the impact of this disease is good, which is why acceptance of government actions was positive. More importantly, the region’s medical and social infrastructure is good, which includes comprehensive insurance coverage (the testing fee was low or a test was free for those with symptoms). South Korea also has one of the highest densities of hospital beds in the world at 115 per 10,000 people (according to WHO data), four times higher than in the US.