Coordinating Centres Special Interest Group

Dr Roberta Littleford

My current role is the Associate Director and Head of Operations of The University of Queensland (UQ) Clinical Trials Centre, which is in its establishment phase. The Centre’s aim is to provide end-to-end collaboration for UQ-sponsored investigator-initiated national and international clinical trials. This includes building an interdisciplinary team for research development and trial delivery for the life cycle of clinical trials.
Before this role, I established the Clinical Trials Support Unit at UQ. Prior to that, I led the development of a streamlined animal ethics strategy—an area I had no prior experience in but found fascinating. This work focused on pre-clinical research ethics and governance, where I oversaw five committees and implemented operational improvements, including efficiencies in documentation and workflows. While the operational principles were similar to those in human trials, the governance structures differed significantly, giving me valuable insights into additional regulatory frameworks and compliance.
Before returning to Australia in 2018, I worked in the UK as Strategic Director of a UK-accredited Clinical Trials Unit, similar to a Clinical Trials Centre in Australia. This role provided me with a deep insight into operating within a mature governance framework, managing accreditation processes, and engaging in competent authority audits, including those conducted by the MHRA and FDA. These experiences shaped my approach to governance and quality, which I now bring to UQ and the ACTA Coordinating Centres special interest group.

Please tell us a bit about the ACTA Coordinating Centres Special Interest Group
The Coordinating Centres Special Interest Group (CC SIG) was established in December 2021 to foster collaboration, share best practices, and address common challenges in the Australian clinical trials sector. I joined over a year ago, bringing insights from the UK, particularly as the group began exploring a national accreditation model for coordinating centres.
A central focus of the SIG is the development of an accreditation framework tailored to the Australian context. To inform this work, the group actively reviews international models and lessons learned—especially those related to governance and quality standards.
By harnessing the collective expertise within the SIG and ACTA, we aim to secure funding and support through peak body advocacy, positioning accreditation as a strategic lever for sector-wide improvement.

How did you become involved with the Coordinating Centres SIG and why were you interested in joining?
I was invited to join the SIG by the current co-chair, Helen Monaghan, and former co-chair, Nadine Foster—an excellent example of how professional networks can open doors to meaningful collaborations across diverse areas of expertise. I saw this as an opportunity to contribute and learn, engaging in a truly symbiotic exchange of insights and experience.

What do you think is the benefit of the Coordinating Centres SIG for the broader research community?
Since the CC SIG’s refresh, much of the focus has been on driving accreditation and securing funding through MRFF grant applications. If successful, this will enable us to move from planning to action and drive meaningful change across the sector.
Currently, there is no consistent standard in Australia defining what a Coordinating Centre should deliver. This creates variability in capability, governance, and quality, which can affect trial efficiency, compliance, and participant safety. An accreditation framework would:
* Set minimum standards for infrastructure, governance, and operational capability.
* Provide assurance to funders, regulators, and sponsors that centres meet consistent quality benchmarks.
* Support workforce development by aligning roles and competencies with recognised standards.
* Enhance international competitiveness, as many countries—such as the UK—already operate under mature governance frameworks with accredited centres.

Another key initiative, led by Helen Monaghan, was the development and distribution of a questionnaire to clarify how people define coordinating centres and networks, as well as their interpretation of key concepts such as sponsorship and governance. The responses revealed considerable variation in understanding, underscoring the urgent need for shared definitions to achieve alignment and best practice across the sector.
Interestingly, even the term “clinical trial” has multiple interpretations. This highlights the importance of creating a unified, comprehensive nomenclature and agreed definitions. Establishing these foundational elements will be critical for improving clarity, consistency, and collaboration across the research community.

Has being part of ACTA and the Coordinating Centres SIG influenced or benefited your work, or professional career?
Absolutely. Being involved in multiple SIGs, including serving as co-chair of the Adaptive Platform Trial Operations (APTO) SIG, has been invaluable. These groups bring together diverse networks, highlight commonalities and differences across organisations, and make it easy to identify who to reach out to for advice or collaboration. There is a strong sense of a community of practice where you can ask questions and receive support without hesitation.
It is also professionally beneficial to have ACTA involvement on your CV as it demonstrates engagement with Australia’s peak body for clinical trials. Beyond that, there is a real sense of contributing to positive change in the research community. The groups are small enough to allow meaningful one-on-one interactions, yet large enough to create broader sector-wide impact.

Would you recommend that others be involved in ACTA and the Coordinating Centres SIG?
Definitely. We have a wide range of professionals involved—medics, clinical academics, operational leads and many others—who often do not have a natural home for collaboration. ACTA provides that home. It brings everyone together under a shared focus on clinical trials, regardless of their role or function. Being part of this encompassing alliance creates a sense of belonging and a platform for collective progress, which is both valuable and rewarding.

How has ACTA supported you and the research community?
ACTA provides a wealth of freely accessible resources, including guidance documents, papers, and webinars, which are invaluable for the research community.
In addition, the special interest groups (SIGs) play a critical role in driving progress. They bring together professionals with a shared commitment to improving clinical trials, often through volunteer efforts. This collaborative approach ensures that common challenges are addressed collectively, fostering innovation and best practice across the sector.

Is there any other way that ACTA could support the research community?
While we have touchpoints across all SIGs, it would be valuable to have greater visibility of what other ACTA groups are working on. For example, collating a portfolio of practical guides for roles such as data managers, trial managers, and health economists would be extremely useful. These could include guidance on budgeting, estimating time for specific tasks, defining scope, and setting appropriate costings for grant applications.
As the national peak body, ACTA also has an important role in advocating for a skilled, supported, and sustainable clinical trials workforce, as well as addressing the sustainability of funding models. We need to consider how to support the next generation, so they are not burdened with excessive unpaid after-hours work, which is currently a significant challenge.
In addition, the rapid evolution of artificial intelligence (AI) presents both opportunities and challenges. ACTA could provide leadership in exploring how AI can be integrated responsibly into clinical trials, considering governance, ethics, workflows, and best practice. The pace of change makes it difficult for individuals to keep up, so having ACTA provide guidance on embracing new technologies, systems, and processes would be invaluable.

The collective strength of ACTA and its members lies in their ability to pool expertise, share lessons learned, and develop sector-wide best practices. By leveraging this collaborative advantage, ACTA can ensure that innovations such as AI are implemented in a way that enhances quality, efficiency, and compliance while promoting sustainability and equity across the clinical trials ecosystem. This approach will help create a future-ready research environment that is inclusive, resource-conscious, and capable of delivering high-quality outcomes.
Looking ahead, I am excited to continue contributing to ACTA’s mission and helping to shape a more cohesive and innovative clinical trials ecosystem in Australia.

For more information on the Coordinating Centres SIG click here.

If you are interested in joining the Coordinating Centres SIG, please email: acta@acta.au