A regional model for clinical trial excellence: lessons from CQHHS Chlamydia translational study

Aim

To build sustainable clinical trial capacity and improve equitable access to research participation in regional Queensland through the successful implementation of a multicentre Chlamydia translational study.

Outcomes

1. Establish Central Queensland as a leading regional site for clinical trials: achieved by becoming the top recruiting site and identifying the highest number of Chlamydia-positive cases in the national multicentre trial.
2. Develop a sustainable, locally based clinical trials team and infrastructure within CQPHU: successfully formed a dedicated
   clinical trials team, built operational capacity, and established a Research Development team for CQHHS.
3. Generate significant research revenue to reinvest in regional clinical research capacity: secured over A$ 2Million in research revenue from a single trial, enabling further development of clinical trial services and capability in Central Queensland.

Background

Access to clinical trials in regional Queensland has historically been limited due to systemic, structural, and resource-related barriers. Clinical trials are typically concentrated in metropolitan centres where research infrastructure, governance processes, and specialist personnel are well established. In contrast, regional health services often lack dedicated research staff, formalised feasibility, and ethics systems, and established collaborative partnerships, limiting opportunities for clinical trial delivery.

This contributes to a cycle where research is not embedded in routine care, and clinical trials are rarely seen as achievable or sustainable in regional contexts. For regional clinicians, this lack of infrastructure results in missed opportunities for research participation, innovation, and professional development. More significantly, for communities, it means limited access to trials that could improve prevention, diagnosis, treatment, and long-term health outcomes. These inequities are particularly evident in Central Queensland, where a high burden of disease intersects with geographic and service access challenges. Chlamydia is one example, remaining the most commonly notified condition in the region, disproportionately affecting young people aged 15 to 29. Many remain under-screened due to stigma, limited awareness, and reduced access to specialist sexual health services. In rural and remote areas, these barriers are compounded, with young people often relying on general practice or outreach services where opportunistic STI screening may not be prioritised, leading to delays in diagnosis,
preventable complications, and ongoing community transmission.

An internal review of research readiness within the Central Queensland Public Health Unit (CQPHU) identified significant gaps, including the absence of dedicated trial staff, limited institutional knowledge of clinical trial conduct, and minimal engagement with the broader Queensland research system. Recognising the need for both structural investment and a cultural shift, CQPHU sought to demonstrate that regional clinical trials were possible, valuable, and sustainable. The opportunity to lead an industry-sponsored multicentre diagnostic trial for a Chlamydia translational study in 2024 was identified as a catalyst for change. Delivered through a decentralised Tele-trial model, with CQPHU as the primary site supporting two regional satellite sites, the trial tested the feasibility of leading a collaborative, industry-sponsored trial from a regional base while addressing a key public health priority.

The trial delivered remarkable outcomes. Central Queensland emerged as the top recruiting site, identifying the highest number of Chlamydia-positive cases state-wide, and generating over A$2M in research revenue. More importantly, it established the foundations for a dedicated clinical trials team within CQPHU, built sustainable research capacity, and proved that regional services can successfully lead industry-sponsored clinical trials. This real-world implementation project serves as a model for improving equity in clinical trial access and capability in regional Queensland.

Discussion

The success of the tele-trial at CQPHU relied on several critical factors, including strong leadership, strategic partnerships, resourcefulness, and a commitment to overcoming regional infrastructure challenges. Central Queensland's unique environment posed significant barriers, particularly in terms of limited resources and clinical trial infrastructure. However, the collaborative approach and innovative mindset of the CQPHU team were essential to achieving success.

Key Success Factors and Environmental Context

The team’s ability to operate in a resource-constrained environment and willingness to innovate were crucial in overcoming logistical and infrastructure challenges. CQPHU demonstrated exceptional leadership, with in-house expertise bridging gaps in trial management. Partnerships with QRCCC and TRI were instrumental in navigating governance, regulatory approvals, and trial design. These collaborations ensured adherence to industry standards and regulatory requirements. The team's flexibility - from creative equipment sourcing to extended clinic hours for participant convenience - was critical to maintaining trial continuity and recruitment momentum.

Lessons Learned and Limitations

The project revealed key lessons in resource management, adaptability, and collaboration. Flexibility in responding to logistical challenges was paramount, and the ability to repurpose equipment and make operational adjustments ensured trial delivery despite regional constraints. However, the lack of dedicated research infrastructure at the outset led to delays and inefficiencies. Reliance on external partners for training and support highlighted the need for earlier investment in internal trial management capabilities. Future projects would benefit from more proactive training and earlier establishment of dedicated research infrastructure.

Strengths, Weaknesses, and Opportunities

Strengths included the team’s resourcefulness, effective partnerships, and successful recruitment strategies. Engagement with community organisations like CQMA allowed the trial to reach underserved populations, ensuring inclusivity in recruitment. This highlighted an opportunity to expand clinical trial delivery across regional Queensland. The newly developed trial management capabilities offer CQPHU the chance to become a model for other regional health services. Additionally, established community ties present an opportunity to engage at-risk populations in future research efforts, enhancing access to trials for underserved groups. Weaknesses included the lack of initial infrastructure, which slowed trial setup and implementation. While the team demonstrated adaptability, a more streamlined process would have been possible with dedicated research facilities and proactive internal training.

Next Steps and Future Directions

Next steps include reinforcing internal research infrastructure to support future clinical trials more efficiently.  Building on the foundation established by this trial, CQPHU is well-positioned to lead regional clinical trials, offering expertise and guidance to other departments and health services in Queensland. Moving forward, CQPHU can strengthen internal monitoring systems and foster community partnerships to enhance recruitment and participation. Expanding the use of Tele-trial models and integrating clinical trials into routine public health practice could improve healthcare access and research engagement in regional areas. This project exemplifies how regional health services can overcome infrastructure challenges and lead impactful clinical research that addresses local health needs.

References

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