In a dynamically evolving landscape of clinical research, the Asia Pacific (APAC) region has emerged as a key player in adopting Decentralized Clinical Trials (DCTs).

BioPharma APAC sit down with industry experts, Jerome Armellini, Asia Head of Clinical Development & Operations Strategy; Li Fern Yong, Asia Decentralized Clinical Trial Deployment Lead; and Angelique Greco, APAC Clinical Project Manager, Project Leadership, all from IQVIA Asia Pacific. Together, they shed light on the recent site survey conducted by IQVIA, offering valuable insights into the challenges and opportunities in implementing DCTs in the APAC region. Join us as they discuss the region's positioning in embracing DCTs, noteworthy findings from the site survey, and crucial strategies for the successful implementation of DCTs in 2024.

The recent site survey conducted by IQVIA provides insights into the perception of clinical trial sites in the Asia Pacific (APAC) region. Could you highlight some key observations that emerged from the survey, particularly in terms of the challenges and opportunities faced by implementing Decentralized Clinical Trials (DCT) in the APAC region?

Running clinical trial operations presents similar challenges worldwide, however, in the APAC region, we deal with a vast array of different healthcare systems in terms of their maturity, sophistication, funding, and access. Nevertheless, the APAC region is considered a prime location for clinical trials as it offers a large and ethnically diverse patient pool. The result of the IQVIA site survey indicated a positive outlook on DCT adoption by investigators, in which they expressed optimism and recognized benefits, including reduced patient burden, improved trial continuity, and enhanced inclusivity in hybrid trial designs.  

That said, several challenges including patient acceptability, technology, and infrastructure need to be addressed to ensure the successful implementation of DCT in this region. For example, the challenges we are facing in the recruitment and retention of clinical trial participants, especially those in remote and underserved areas, and the need to bridge the digital divide to ensure equitable access to technology for effective data management and patient monitoring. Collaborative efforts by multiple stakeholders are required to overcome these challenges, thus ensuring that clinical trials are conducted ethically and efficiently in the APAC region.

DCTs have become increasingly relevant in the evolving landscape of clinical research. From your perspective, how has the APAC region positioned itself in embracing DCTs, and what role do you see DCTs playing in the future of clinical trials in this region?

 Although the use of DCTs has been discussed over the past decade, the COVID-19 pandemic is thought to be the catalyst that accelerated their adoption and now it has become an integral part of the clinical trial landscape. Coupled with the advances in digital technology, the APAC region is emerging as a significant player in DCT adoption, as evidenced by the growing support of regulatory bodies in countries including Malaysia, Taiwan, and China. In addition, recognizing the region’s varied technological infrastructure, sites and sponsors are proactively bridging the technological divide to support DCT implementation.

With increasing support from the government, sponsors, and investigators, DCTs are well-poised to play a transformative role in the future of clinical trials in the APAC region. We strongly believe that the adoption of DCTs will reduce patients' and sites’ burden, broaden patient access to clinical trials, increase patient participation, and eliminate geographical disparities, ultimately resulting in a more inclusive and representative patient pool in clinical research. DCTs can also promote better patient engagement and encourage adherence to treatment protocols, resulting in improved patient experiences and optimizing health outcomes. Additionally, DCT utilizes electronic clinical outcome assessment (eCOA), connected devices, and wearables. These technologies enable real-time data collation which reduces data collation errors, thereby enhancing data quality and significantly improving the overall quality of clinical research.

As we look ahead, the future promises continual advancement in technology, anchoring of trusted partners, vendors, and networks, greater interoperability of platforms with trial operations, clear regulatory guidelines globally, and increased awareness of DCTs among all parties involved. Ultimately, DCTs as a hybrid approach are here to stay, and we look forward to seeing them play an increasingly prominent role in improving patient outcomes in this region.

IQVIA's recent site survey focused on DCTs in APAC. What were the most noteworthy findings that shed light on how sites in the region are adapting to and incorporating decentralized approaches? Are there any surprises or notable shifts in practice compared to previous years?

Globally, despite the accelerated implementation during the pandemic, we have seen a slight slowdown in DCT adoption in 2022, although it remains significantly higher than in pre-pandemic times.

In the APAC region, we have observed that DCTs are gaining recognition among investigators due to the potential to alleviate patient burden during the follow-up process and ensure trial continuity, amongst other benefits. Traditionally, patients come to the investigator and return for follow-up assessments, but with DCT, they can receive nursing or phlebotomist visits at home to draw blood samples. Alternatively, patients can be seen by local physicians or examined via telehealth methods which serve as the sub-investigator reporting to the primary investigator who is evaluating the patient remotely.

While we have received positive feedback where our investigators see DCT as an opportunity to bring clinical research directly to our patients, some investigators were not familiar with DCT, which underscores the need for early engagement, better education about the array of available options, and comprehensive on-site training.

To foster successful DCT implementation, we believe it is crucial to engage all relevant stakeholders from the get-go, as well as establish an inclusive process design and adopt best practices to drive fruitful collaboration. Having said that, challenges arise as trial sites are often engaged in multiple trials with various sponsors, contract research organizations (CROs), and vendors, each proposing their distinct training and platforms, which can impose an additional burden, potentially offsetting the benefits designed to alleviate their tasks. This points towards the pressing need for greater interoperability, integration, and standardization of platforms and training, along with fair compensation for the time site staff dedicate to these activities.

Looking ahead to 2024, could you elaborate on areas that research sites should pay attention to in the coming year? Specifically, how can sites leverage technological advancements, address data privacy concerns, and implement patient-centric trial designs to enhance the conduct and success of DCTs in APAC?

As we are seeing more APAC investigators embracing DCTs, research sites must adopt specific strategies to enhance the conduct and success of DCTs in 2024.

Research sites need to embrace technological advancements to drive DCT implementation in APAC. Digital infrastructure readiness and availability of connectivity at research sites are among the key aspects. The infrastructure forms the backbone of data collection, patient monitoring, and communication, ultimately impacting the quality and efficiency of the entire trial process.

Next, confidentiality, data privacy, and security play a critical role in DCTs. Research sites will need to ensure compliance and adherence to local data privacy regulations, while also implementing robust data security measures, for example, access control mechanisms, to prevent any unauthorized access to patient data. 

Lastly, implementing patient-centric trial designs is crucial to promote efficiencies and outcomes of DCTs. Research sites are encouraged to actively seek patient feedback throughout the trial design process to understand their underlying motivations and potential challenges that may discourage participation.

The success of DCT hinges on the early engagement of stakeholders, including sponsors, investigators, patients, vendors, CROs, and regulators. This necessitates the involvement of research sites from the very beginning of the protocol design to ensure the adequacy of deploying DCTs by placing the patient at the forefront of consideration. Patient involvement and their opinions are paramount in clinical trials to ensure a greater and more inclusive recruitment of the targeted patient population.

By employing these strategies, we believe research sites in the Japan and Asia Pacific (JAPAC) region will be able to achieve greater success in implementing DCTs.

Technology plays a crucial role in the advancement of decentralized trials. What are some notable technological advancements that are expected to shape the landscape of DCTs in the APAC region, and how can stakeholders, including research sites, effectively integrate these technologies into their trial processes?

Enabled by technological advancement, this innovative approach plays a pivotal role in enabling these remote trial-related activities, including telemedicine, electronic data capture, e-consent, electronic Patient-Reported Outcome (ePRO) and eCOA, connected devices and wearables, creating a participant-centric and efficient trial process. Essentially, it is a clinical trial in which data collection, patient evaluation, and care are conducted outside the traditional investigator site environment with the help of critical digital components. For instance, patient consent forms, traditionally in paper format, can be digitized, and data can be collected and analyzed using electronic devices such as smartphones and wearable devices. Patients do not have to physically come to the site for their health assessment.

Shifting from traditional approaches to hybrid modes poses a challenge for stakeholders accustomed to the conventional model. To navigate these challenges, fostering early engagement and embracing an inclusive process design among sponsors, CROs, researchers, technology providers, healthcare providers, and patients can pave the way for fruitful collaboration and ultimately, the successful implementation of DCTs. In conclusion, prioritizing stakeholder engagement and education, adopting best practices, and addressing region-specific challenges are essential steps to foster successful DCTs in the APAC region.

Patient-centric trial designs are emphasized as a key area of focus for 2024. In what ways do patient-centric approaches enhance the overall clinical trial experience, and how can sites ensure the successful implementation of these designs while maintaining the highest standards of data quality and privacy in the JAPAC region?

The successful DCT implementation requires proactive and preemptive planning, always keeping the patient's voice in mind, and cannot be an afterthought. DCT can alleviate a significant burden on both researchers and patients, allow for a more diverse population to participate globally, and offer advantages such as accelerating the speed of clinical trials and achieving cost efficiency.

Good clinical practice and the close monitoring of guidelines remain essential for DCT stakeholders. It is important to ensure that DCT stakeholder responsibilities are clearly outlined, establishing transparent communication lines and efficient response turnover. Ultimately, investigators bear the responsibility for patient safety, prioritizing patient comfort, with the network of technology and services. Therefore, early consultation with research sites for vendor and technology selection is a priority.

The essential need for robust data quality and integrity checks also necessitates a primary focus on real-time monitoring. Furthermore, the implementation of contingency plans is vital in mitigating the impact of potential technology failures.

By incorporating these key considerations and options, a robust foundation can be laid for the successful execution of DCTs in the APAC region.