Key considerations for decentralized clinical trials in Australia

Since 2020, Australia has witnessed a significant transformation in the clinical trial landscape with an increasing adoption of decentralized approaches. The COVID-19 pandemic highlighted the necessity of remote healthcare solutions, accelerating the shift toward virtual models to ensure continuity in clinical research during lockdowns and restrictions. As such, this has contributed to the current growth of decentralized clinical trials (DCT).

This trend is reshaping the traditional clinical research model globally by leveraging digital technologies and remote capabilities, making decentralized models a viable and efficient option for sponsors. This blog delves into the rise of decentralized clinical trials in Australia, exploring the key components, benefits, challenges, and regulatory considerations associated with this approach.

Understanding decentralized clinical trials

Decentralized clinical trials represent a departure from the conventional, site-centric model. These trials leverage digital technologies and integrated logistics to conduct various aspects remotely, such as electronic data collection, telemedicine consultations and remote monitoring, reducing the need for participants to visit physical research sites.

Remote data collection can be achieved through wearable devices, mobile apps, electronic Patient Reported Outcome (ePRO) diaries, and other tools that track vital signs, medication adherence, and other relevant health indicators. When applied carefully and consistently, these tools can provide a more comprehensive and accurate representation of a participant's health status over time, offering valuable insights for researchers. Additionally, logistics for sample collection and analysis, as well as the storage and dispensing of investigational products are crucial, with Direct to Patient (DTP) logistics and pharmacies playing a key role.

Benefits of decentralized clinical trials

Adopting a decentralized clinical trial model in Australia brings forth many benefits for participants, researchers, and sponsors alike.

• Improved access to participants: Decentralized trials enhance accessibility by enabling more participants to contribute to research from the comfort of their homes and local areas. This broadens the participant pool and includes individuals who may otherwise face geographical or mobility barriers to entry.
• Reduced on-site and personnel costs: Decentralized trials reduce the need for extensive physical infrastructure at sites and for on-site monitoring, reducing costs associated with site maintenance, travel reimbursements, and personnel. These trials also reduce the time, money, and environmental impact associated with participants and trial monitors regularly travelling to the site. However, it’s worth noting that some of these reductions may be reallocated to logistics and assessment of remote data collection methods. Ultimately, sponsors will have the opportunity to allocate resources more efficiently across trials and programs.
• Faster recruitment and data collection: Decentralized clinical trials facilitate faster recruitment by reducing participant burden, using digital recruitment tools, and streamlining screening processes. They also expedite data collection through continuous monitoring, automated data entry, enhanced participant engagement, and remote oversight, collectively accelerating the overall research timeline.

Challenges and limitations

While decentralized clinical trials offer promising benefits, they are not without challenges. Addressing these challenges is crucial to ensuring the success and integrity of your research. Here are some key considerations:

• Participant engagement: Maintaining consistent participant engagement can be challenging in decentralized clinical trials. To do so, trial coordinators must employ strategies such as regular communication through different methods. Meanwhile, Sponsors need to employ user-friendly technologies, gamification, or other incentives to keep participants actively involved.
• Data security and privacy concerns: With the increased reliance on digital platforms, ensuring the security and privacy of participant data becomes paramount. You should implement robust encryption and cybersecurity measures to ensure adherence to strict data protection protocols. This is also essential in mitigating participant and other stakeholder concerns around data privacy.
• Source data and monitoring: The requirements for source documentation need to be considered. What data will be directly entered into systems and exist as both source and data? How will data be monitored and can the data be corrected if required?
• Allocation of responsibilities: Ensuring the responsibilities of sites and investigators as outlined in GCP, are allocated appropriately is an important consideration when setting up a DCT. Questions include:
   
  • ‘Who is managing the clinical status of participants and how are they doing this?’
  • ‘What happens if there is an adverse event?’

The rise of decentralized clinical trials signifies a transformative era in healthcare research. These trials, especially suited for large-scale, later-phase studies that replicate real-world treatment conditions, offer a more authentic assessment of treatment effectiveness. By combining these trials with digital technologies, Australia is poised to make significant strides in advancing medical research and improving patient outcomes.

If you want to learn more about how to successfully navigate clinical research in Australia with a team of professionals committed to safe, secure, and ethical studies, get in touch with us today.

Southern Star Research is a full-service Australian Contract Research Organization. We help sponsors run safe and efficient trials that meet regulatory requirements, ensure scientific excellence, and demonstrate the commercial viability of your product. If you're looking for an agile and dedicated team to help you run a successful trial, contact us today.