Decentralised Clinical Trials (DCTs) are trials that use digital technologies to communicate with study participants, bring clinical research closer to patient’s home and to collect study data. DCTs reduce burden on participants and offer a patient-centric approach to clinical trial management that differs from the traditional model. Examples of digital technologies include eConsent, telemedicine, electronic patient reporting (ePRO), mobile health, wearables and remote patient monitoring. Other terms often used interchangeably with DCT are Virtual, Site-less or Remote Clinical Trials.
DCTs create even stronger opportunities for conducting research in APAC, and the region is poised to become the next frontier for decentralised trials. Sponsors and Contract Research Organisations (CRO) should get ahead of the curve by exploring the region’s strategic landscape for clinical research.
What is the appeal of APAC for clinical trials and DCTs?
The participant pool across APAC 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: Due to the higher proportion of treatment-naïve patients across APAC, this enables sponsors to tap into a greater patient population pool offering patients more opportunities to participate in clinical trials and obtain access to new therapeutic treatments.
- Similar disease patterns: conditions present similarly in APAC populations allowing contribution of data to global clinical research programs
- Technology adoption: APAC consumers and industry leaders are known to embrace innovation and the region has emerged as a global technical 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.
- Rapid growth of pharmaceuticals in developing countries: Asia is the fastest-growing global market for pharmaceutical sales.
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. Highly skilled talent is usually available at a lower cost when compared to similar roles in countries such as the US and Western Europe. Countries such as Australia offer tax incentives to conduct clinical research and development.
- Lower trial density: APAC’s large patient population and its lower volume of studies overall create a lower trial density across the region and smaller risk of competing trials.
- Efficiencies in recruitment and retention: APAC often witnesses faster enrollment periods and competitive recruitment rates when compared to the US.1
It’s also important to highlight that faster, more efficient trials does not mean compromising on quality. APAC has a track record of high-quality data and acceptance of this data by the key Regulatory bodies FDA and EMA for early phase and registrational programs, and capabilities in the region include:
- exceptional medical research infrastructure in terms of hospitals, research institutions and clinical research sites
- protections for intellectual property
- over 50,000 active Principal Investigators that support clinical trials
DCTs: A patient-centric approach
When patients are given user-friendly options for interacting with the study team, they are empowered to take an active role in the improvement of their health while contributing to clinical research. Current approach to running a clinical trial can sometimes overlook the importance of patient engagement. A patient-centric approach can have a profound impact on research by reducing dropout rates, increasing patient compliance and producing higher quality data that can be provided in real-time.
Key considerations when conducting DCTs in APAC
With such a promising landscape, it is important to remember that Sponsors and CROs have faced some challenges with implementation of DCTs including:
- Working with regulators: Despite improvements in understanding the regulatory environment and guidelines around DCTs, work still needs to be done. In most countries regulators are open to and eager to embrace these new method. They are in need of data and expertise from DCT leaders to ensure that all safety precautions are taken and that approaches are adapted as required to the specific region. Sponsors should collaborate with local expertise in the region to successfully navigate this arena
- 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 DCT without the proper reassurance. This can be addressed via local virtual support teams, and partnering with providers with local presence
- Perceptions of DCTs: APAC is known for innovation, but misconceptions about DCTs persist. Some APAC-based sponsors who have had limited exposure to DCT’s may view them as inferior and hence the sector’s caution when it comes to embracing this model more fully.
Local partnerships: The missing link
Despite some of these lingering challenges with DCT, the outlook for clinical research in APAC 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, especially for DCTs.
Together, Novotech and ObvioHealth are helping sponsors unlock the potential for DCTs in APAC—allowing them to conduct patient-centric, cost-effective studies, identify meaningful outcomes and advance medical research innovation.
- Source GlobalData report: Accessed July 23rd, 2021