Unlocking the future of Australia's clinical trials

COVID-19 has highlighted the vital importance of clinical trials for drug and vaccine development, but it has also forced companies to completely redesign how these trials are run. With the pandemic creating appetite for the wider adoption of virtualisation technologies, it’s critical for the future success and development of the clinical trial sector to decentralise components of the process.

A decentralised clinical trial uses a suite of technologies to virtualise whole or parts of the clinical trial continuum by integrating technology into workflows. From a web-based patient portal enabling virtual patient participation in clinical trials, to virtualizing solutions that enable remote data capture and telehealth visits, decentralisation is aimed at streamlining the experience for patients, sponsors, and clinical research organisations (CROs). Decentralisation leverages technologies like digital tools and sensors to remotely capture insights and help improve clinical outcomes, lower costs, and enable greater operational efficiencies — and thereby accelerate the pace of drug development.

In a time of restricted movement, the clinical trial industry (like many others) migrated clinical services to the home to enable important research to continue remotely. The pandemic has shown that there’s a lot more flexibility in the clinical trial systems than was realised in the past. It has also been revealed that clinical trials contributed $1.4 billion¹ to the Australian economy through direct expenditure or investment. The pandemic and fostering the growth and realised economic opportunities associated with clinical trials, has been a catalyst in speeding the digital process, making virtual trials a reality.

A data-led approach to decentralised clinical trials

Every trial is different, and each requires a unique approach to virtualisation. To elevate the trial digital capability, the right virtual approach needs to be considered with the following in mind: phase; disease/condition; patient population; risk profile; and endpoint requirements for researchers. A critical success factor is understanding what is key in determining the right virtual approach and how this will be managed virtually or onsite.

This all begins with the data. There are now more data sources, types, and endpoints than ever before. But the full story of a patient requires a more holistic view. Having a holistic view as part of a unified platform ensures flexibility to reach patients through different methods. Clinical trial companies must look for partners and providers not only with holistic innovative technology but backed and supported by professional expertise to deliver a truly unified solution and ensure efficient deployment and faster technology adoption.

Developers can use a suite of technologies to help support and accelerate holistic clinical development, including EDC (electronic data capture), eCOA (electronic clinical outcomes assessment) and Detect (centralised statistical monitoring). Having all these solutions as part of a single, unified platform, gives the flexibility to reach patients through different modalities, as needed for the study.

Powerful analytics continually monitor patient data

For an industry that has relied on paper-based documentation and patients being monitored at fixed sites for decades, this is a breakthrough with huge potential benefits, centred on data. In fact, changes to clinical trials that enable remote data verification are in the public interest for Australians². The future of decentralised trials relies on the ability to take this high velocity, high volume patient-centric data and turn it into useful insights, to drive better study execution models.

The ability to make sense of this data, to centralise, aggregate, analyse and derive meaning from it, will drive the next generation of clinical operations and will be a key differentiator. There is also a series of solutions and capabilities that exist on top of unified data. The insights from data analysis are fundamentally embedded into the workflows and are surfaced when and where they are needed.

These capabilities mean virtual clinical trials can now start to bring together traditional data management teams with the central monitoring group. Leveraging real-world data to drive trials and analyse quickly, offers the promise of more efficient, safe, and fast-paced trials. It poses the opportunity for researchers to quickly achieve more and gain meaningful insights.

Digital oversight enables clinical operations excellence

At an industry level, there is a struggle to efficiently and continuously manage clinical trials due to a fragmented and rapidly changing trial ecosystem. As a result, clinical operations must evolve at the pace of the research it supports. There are three key areas where clinical operations must evolve to meet the needs of today’s complex trials.

The first is trial execution. Optimised trial operations require effective communication and information sharing. Traditional clinical operations practices require data entry within multiple siloed locations, which creates a high risk that key activities and actions will be missed and the risk of data inaccurately captured. Next is the ability to augment the strategy for clinical operations towards risk-based approaches using risk-based quality management (RBQM) principles, where most don’t adopt a holistic end-to-end solution. Finally, we know that future trials will not look or perform the same as they have in the past. Today’s technologies must be able to support all manner of brick-and-mortar as well as decentralised trials.

At the intersection of excellence is digital oversight. Oversight enables continuous data monitoring from anywhere, allowing sponsors and CROs to innovate and optimise their approach to trial design, physical and virtual interactions with sites, and holistic portfolio strategy. Interoperability is critical. The risk to decentralised clinical trial data quality is high because the patient is not in a controlled environment. Technology needs to be integrated into the operational and decision-making processes.

Flexibility for continuous, compliant, collaborative data capture

There are outstanding benefits in using decentralised technology. For patients, this means a single clinical trial dashboard for life, enabling remote visits, data collection and allowing for greater access. For sites, technology standardisation streamlines patient care, enables remote research to reduce study obligations and removes barriers with participation. For sponsors, there’s continuous clinical data capture enhancing data quantity and quality and ensuring a truly patient-centric approach.

There has been a significant resurgence of interest from all stakeholders involved in the decentralised model. Convenience, compliance, and improvements in assessments have all contributed to this. Post COVID-19, we don’t anticipate decentralised clinical trials slowing down. While COVID-19 was a trigger for decentralised clinical trials, the industry will never return to its old ways.

References

¹ New Report: Australia’s Clinical Trials Sector Shows Healthy Growth — https://www.mtpconnect.org.au/Story?Action=View&Story_id=379

² Changes to clinical trials that enable remote data verification — https://www1.health.gov.au/internet/main/publishing.nsf/content/EE207D978A44E4B8CA257FA90081B212/$File/CTPRG%20Statement%20on%20Clinical%20Trials%20during%20COVID-19.pdf

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