Primary Care 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
Are you a primary care researcher starting a new clinical trial and interested in collaborating with our Department? This page provides information on what we do and our fields of expertise.
If you are interested in working with our researchers and would like to know more, submit your request here:
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
How we do it - consult and recruit
VicREN is a primary care, practice-based research and education network. VicREN enables us to facilitate collaborative research in primary care settings. Our collaborators can benefit from various levels of assistance.
Contact VicREN for enquiries:
Collaboration. Department of General Practice and Primary Care academic GPs can collaborate on general practice projects arising outside of our Department. This can have many benefits. The extent of the collaboration varies from project to project.
Our collaborators benefit from our research expertise including designing studies for the unique general practice environment, providing 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 of 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 and Primary Care 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
Research interests within the Department of General Practice and Primary Care are listed below. Please click on the links for more information about our research projects.
- Cancer in primary care
- Children and young people's health
- Data driven quality improvement
- Data for decisions (use of large primary care data sets to improve knowledge, education, policy, medical care)
- Diabetes and cardio-metabolic conditions
- Health data science for medical research
- Primary care mental health
- Sexual abuse and family violence
Our team
The Primary Care Clinical Trials Unit draws on the resources of the Department of General Practice and Primary Care 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
Interested in collaborating with our Department? Complete our online request form here:
Contact us
Department of General Practice and Primary Care, The University of Melbourne, 780 Elizabeth Street, Melbourne, Victoria, 3004 Australia