Primary Care Clinical Trials Unit

Specialising in primary care clinical trials

The Department of General Practice, 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 University of Melbourne 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:

  • Practice and participant recruitment
  • 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
  • Recruitment and promotion
  • 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

Recruitment & GP consulting services

VicREN is a primary care, practice-based research and education network. VicREN enables us to facilitate collaborative research in primary care settings. We can provide various levels of assistance. Contact VicREN for pricing and service enquiries:

Consulting advice for researchers intending to undertake research in the primary care setting, this includes designing studies for the unique environment of general practice, methodological advice around recruitment of GPs/practices and patients, and creation of appropriate recruitment materials and advertisements.

Advertising/promoting studies through the distribution and promotion in regular e-bulletins and notices to GPs, practice managers, practice nurses and broader primary care organisations.

Recruitment services to recruit GPs, general practices and/or patients. The level of involvement can range from:

  • identifying a GP/practice that may be interested in a study and passing on details to a researcher and/or recruiting a GP advisor / associate investigator for a study
  • engaging with and visiting practices, educating staff about study details, and gaining their consent to participate
  • recruiting patients for trials within consenting practices under direction from the research team
  • identifying patients who may be eligible in our Data for Decisions/ Patron network and working with the GP practice to recruitment them
  • organising and hosting events, e.g. focus groups

Our experience & networks

Since 2005, we have led over 25 randomised controlled trials (RCTs) of which 56% of these trials have been funded in the last 5 years. Over 370 general practices and more than 24,000 participants were randomised across the 25 randomised controlled trials.  We have expertise in the design and analysis of pragmatic trial in the primary care setting, particularly multi-site trials, cluster randomised trials, and stepped wedge designs. In addition to the conduct of randomised controlled trials, the Department has expertise in process and outcome evaluations, which determine whether the intervention has been implemented as intended. Qualitative methods are often used for this, as they offer information specific to the context of trial.

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.

Established in  2007, VicREN, our primary care, practice-based research and education network has over 200 individual members. In addition, over 100 general practices and community health centres partner with us in Data for Decisions - forming our e-based research network. Through VicREN we facilitate collaborative research in primary care settings without compromising or interrupting clinical 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 and messaging 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

A/Prof Patty Chondros (Lead biostatistician)

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

Email VicREN and Data for Decisions: