Clinical Trials Unit

Specialising in primary care clinical trials

The Primary Care Research Clinical Trials Unit supports the development, conduct and analysis of high quality trials in primary health care and health services

Our Focus

Our specialised team of primary care researchers develop and conduct clinical trials with a wide range of collaborators. Our focus is on health services research and implementation science using primary care innovation, clinical data analytics and linkage, and co-design with consumers and practitioners. We are experts in research and implementation in the complex, multidisciplinary primary care environment. We have expertise in:

  • Implementation science
  • Design and development of complex interventions
  • Clinical and health services research
  • Co-design working with the consumer interface
  • Data linkage within and across sectors
  • Use of de-identified GP patient data in trials and evaluations (Data for Decisions - using data from the Patron primary care data repository)
  • Risk stratification

In addition, we develop and conduct process and outcome evaluations. These determine whether the intervention has been implemented as intended. Qualitative studies are often used for this because they offer contextualised insights into the trial.

What we do

  • Trial protocol development
  • Sample size calculations
  • Trials management
  • Randomisation schedules
  • Development of Statistical Analysis Plans (SAP)
  • Process and outcome evaluation
  • Database development (including bespoke tracking databases)
  • Data management and processing
  • Co-design expertise at the clinical interface
  • Processing and analysing large clinical datasets extracted from General Practice records
  • Research translation and implementation for improved clinical practices and better patient outcomes

Our experience

Since 2005 we have led over 15 randomised trials, involving over 400 general practices and over 12,000 participants randomised in Australia. Examples of complex interventions evaluated include health risk screening in young, screening and counselling of women who have experienced intimate partner abuse, acupuncture for post-menopausal women, insulin initiation in type 2 diabetes, testing a co-design to optimise psycho-social recovery of people affect by mental illness and testing of risk assessment and decision support tool for depressive symptoms and cancer screening.

Some Department of General Practice staff are also part of the Primary Care Collaborative Cancer Clinical Trials Group (PC4) which specialises in trials related to all aspects of the cancer continuum from prevention to palliative care.

Example projects

See here for information on Department of General Practice research projects.

Our team

The Primary Care Clinical Trials Unit draws on the resources of the Department of General Practice and beyond to bring together the appropriate team for individual clinical trials. Our team includes:

  • Methodology specialists
  • Clinician researchers
  • Participant recruitment specialists
  • Trial coordinators
  • Biostatisticians
  • Econometrists
  • Data engineers, analysts and programmers
  • Applied ethicists
  • Qualitative and mixed methods researchers
  • Database managers
  • Evaluation specialists
  • Health services researchers

Contact us

Dr Patty Chondros (Lead biostatistician)

Department of General Practice, The University of Melbourne, 200 Berkeley Street, Carlton, Victoria, 3053 Australia