Opinion Piece Veeva Systems

Australia’s clinical trial revolution – The power of stakeholder collaboration

Opinion piece – Pradeep Jandhyala, Senior Account Partner, ANZ Team Lead & Asia CRO Lead, Veeva Systems

In the wake of the COVID-19 impact, Australia has experienced a surge in clinical trials, positioning its clinical trials sector as an attractive market in the face of a more stringent global investment landscape. But Australia, too, is grappling with challenges and opportunities in its quest for a future-proofed and world-leading trials system.

Often lauded for its world-class status, Australia’s clinical trials landscape is underpinned by an eclectic mix of large and small research organisations and a growing digital health industry buoyed by government and private investment.

On the one hand, this is conducive to an innovative sector, where small research and biopharmaceutical players drive an exciting drumbeat of new discoveries while established organisations ensure scale and best practice. On the other hand, it can cause fragmentation in processes, standards, imbalanced competition, and cumbersome regulation.

Challenges in the clinical trial landscape in Australia

Indeed, Australia’s challenges are complex, but not uncommon. The industry encounters complex regulatory pathways, a lack of regulatory harmonisation and unnecessary red tape. High costs, inconsistent ethics committee reviews and lack of patient awareness are just some of the challenges players in the industry face.

The consequences of all these are acute and inevitably felt by everyday Australians. These range from barriers to trial participation and limited access to new therapies, to long waits for primary and hospital care owing to the slow market access for innovative, preventative medicines.

A key underlying issue is the lack of stakeholder collaboration in such a diverse market. Stakeholders – including sponsors, researchers and healthcare professionals – still largely work in silos, whether that be due to their systems, processes, sites or commercial objectives.

Fragmented technological infrastructure in Australia

Fragmented technological infrastructure – from one government body or from one biopharmaceutical to another, or between smaller clinical research organisations – is one of the great challenges of our industry.

This creates significant data use barriers for researchers and impedes progress in developing life-saving therapies, diagnostics, and devices, and creates a prohibitive market environment for newcomers and innovators.

Veeva’s latest MedTech Clinical Benchmark Report revealed that disconnected systems remain a crucial issue for the industry. Over half of MedTech professional respondents face challenges due to fragmented clinical systems, impacting cross-system integration, data management, reporting, and usability.

A key reason for system fragmentation is the diversity of stakeholders, each with their own perspectives, goals, unique implementation challenges, system preferences and biases. This diversity often leads to siloed systems and data, making collaboration difficult.

In addition, few system providers are currently addressing technology silos in Australia, creating significant barriers to building a supportive ecosystem and making industry-wide changes. While competition amongst systems providers is healthy for the industry, players should also be working towards the common goal of harmonising processes. System incompatibility in the industry can only be addressed by a collective move by stakeholders to improve synchronicity between systems and data collection.

Looking ahead to the future

Collaboration is key in clinical trials. No single platform or data contributor can tackle the challenges alone. By working together, stakeholders in the clinical trial process can improve data flow and accelerate the development of life-changing therapies.

The trick to this will be harmonising the interests of regulatory bodies, technology providers, and trial sponsors. Their joint efforts are imperative to ensure robust solutions that benefit the entire clinical trial ecosystem.

System providers need to take the lead in developing different solutions that allow stakeholders to effectively communicate with one another. For instance, one of our patient solutions, Veeva vPRO, is closely linked with site solutions. This integration allows sites to engage with patients more easily and swiftly, facilitating the flow of data from sites to CROs and sponsors. As a result, sponsors gain earlier insights into the performance of the clinical trial, including early positive results for their investigations.

Governments also need to act proactively to facilitate multi-stakeholder collaboration and faster data sharing. In recent years, we have witnessed the new reforms to Australia’s National One-Stop Shop for clinical trials, and these reforms have been instrumental in overcoming the institutional inertia prevalent in Australia’s clinical trials sector. However, the National One-Stop Shop could also further incentivise industry groups and encourage collaboration and information sharing to enhance best practices in clinical trials.

Like many nations, Australia’s clinical trials and biopharmaceutical space is a realm of promise, but it continues to grapple with an array of entrenched system challenges that keep it from reaching its full potential.

As Australia endeavours to enhance its position on the global clinical trials map, stakeholders must go one step further from this current level of collegiality towards the single goal of a better run system, showing a steadfast commitment to doing away with the legacies of old.