Clinical Epidemiology & Biostatistics (CEBU)
High-level expertise in data science underpinning evidence for better health in children and young people.
The Clinical Epidemiology and Biostatistics Unit (CEBU) specialises in biostatistics, epidemiological methods, and data management. With co-funding from the University of Melbourne, we provide expertise and support to all researchers on the Melbourne Children's campus.
The group’s work is important across many clinical and health problems, because almost all modern research involving patients and children relies heavily on statistical methods to design and analyse high-quality studies and interpret the results appropriately.
Our research
We are statistical collaborators on a wide range of clinical and population health research studies. We also conduct our own methodological research, both to develop and strengthen the biostatistical methods underpinning modern health research and to develop advanced expertise.
Our group’s work on cutting-edge methods for handling missing data problems, modern causal inference and adaptive platform trials has attracted international recognition.
We are a leading example of how internationally renowned biostatistical expertise can be developed and integrated with major health research programs.
Researcher training and tools
We are dedicated to promoting high-quality research standards. We offer expert-led training and resources to support both new and established researchers in clinical and public health fields:
Contact us
Clinical Epidemiology & Biostatistics (CEBU)
Email:
show email address
Group Leaders
Team Leaders
Group Members
Our projects
Addressing new challenges with missing data in complex epidemiological studies: methods, guidance and software
This research program continues to add to knowledge and guidance on effective use of methods such as multiple imputation and inverse probability weighting to handle missing data in health research.
CEBU researchers: Katherine Lee, Margarita Moreno-Betancur, John Carlin, Ghazaleh Dashti, Rheanna Mainzer, Rushani Wijesuriya, Melissa Middleton, Cameron Patrick and Qianying Tang
Causal inference in health data science: advancing understanding and methods
This program of research aims to develop, disseminate and promote the adoption of modern causal thinking and related methods in medical and health research.
CEBU researchers: Margarita Moreno-Betancur, Ghazaleh Dashti, John Carlin, Marnie Downes, Daisy Shepherd, Tong Chen, Rushani Wijesuriya, Susie Ellul, Anthony Parissi, Zachary Anderson-Cutting and Qianying Tang
Adaptive platform trials
We have a rapidly growing portfolio of research surrounding adaptive platform trials, in particular the development, evaluation and analysis of ordinal that are becoming increasingly popular in such designs.
CEBU researchers: Katherine Lee, Robert Mahar, Chris Selman, Melissa Middleton and Leon Di Stefano.
Australian Trials Methodology (AusTriM) Research Network
The AusTriM network brings Australia’s leading biostatisticians with expertise in trials together with investigators who conduct landmark trials to develop, evaluate and apply innovative approaches in design and analysis of clinical trials.
CEBU researchers: Katherine Lee, Robert Mahar, Chris Selman, Melissa Middleton and Leon Di Stefano.
Victorian Centre for Biostatistics (ViCBiostat)
Originally funded by an NHMRC Centre for Research Excellence grant, ViCBiostat provides support for postdoctoral biostatisticians and PhD students working on a range of methodological research projects.
CEBU researchers: Margarita Moreno-Betancur, John Carlin, Katherine Lee and Ghazaleh Dashti are in the Leadership team, with all CEBU staff involved in methodological research being members.
Selected collaborations in health and medical research
Melbourne Children's Trials Centre (MCTC)
In our role with the MCTC we work to design and analyse randomised controlled trials to address important questions about effectiveness of a wide range of clinical and population health interventions with researchers across the Melbourne Children's Campus.
CEBU researchers: Katherine Lee, Anneke Grobler, Francesca Orsini, Robert Mahar, Chris Selman, Melissa Middleton, Leon DiStefano, Cecilia Moore, Xiaofang Wang and Alannah Rudkin.
Melbourne Children's Trials Centre
LifeCourse Initiative
We provide methodological leadership to a wide range of clinical and population-based longitudinal cohort studies part of the LifeCourse platform at the Melbourne Children’s.
CEBU researchers: Margarita Moreno-Betancur, Marnie Downes, Ghazaleh Dashti, Daisy Shepherd, Tong Chen, Rushani Wijesuriya, Susie Ellul, Anthony Parissi, Diana Zannino, Suzanna Vidmar
Generation Victoria (GenV)
We provide high-level support with respect to research design and biostatistics to this major initiative to create a large state-wide cohort study of newborn children.
CEBU researchers: Katherine Lee, Margarita Moreno-Betancur, Daisy Shepherd and Francesca Orsini
Centre for Adolescent Health (CAH)
We have a longstanding collaboration with CAH, providing support to two major longitudinal cohort studies: the Victorian Adolescent Health Cohort Study (VAHCS) and the Childhood to Adolescence Transition Study (CATS).
Lead researchers: Margarita Moreno-Betancur, Ghazaleh Dashti and John Carlin, with George Patton and colleagues.
Centre for Adolescent Health (CAH)
Neurodisability and developmental group
We provide statistical support to this group’s extensive range of studies into the causes and management of childhood disabilities.
Lead researchers: Margarita Moreno-Betancur and Daisy Shepherd, with David Amor.
Victorian Infant Brain Study (VIBeS)
Exploring long-term neurodevelopmental and health outcomes in very preterm babies and their families.
Lead researchers: Katherine Lee and Diana Zannino with Peter Anderson, Deanne Thompson and colleagues.
More on VIBeS.
Barwon Infant Study
A prebirth cohort study investigating the interplay between the modern environment and the early life origins of eczema, food allergy, asthma and atherosclerosis.
OPTIMIST Trial
A multicentre randomised controlled trial of minimally-invasive surfactant therapy in very preterm infants on continuous positive airway pressure.
OPTIMISM is a four-week study that aims to compare the effects of two dietary patterns on depressive symptoms and other outcomes including anxiety, microbiome composition, gut permeability, and inflammation among adults with and without depression.
PLUSS Trial: Preventing Lung Disease Using Surfactant + Steroid
A multicentre randomised controlled trial of surfactant plus budesonide to improve survival free of bronchopulmonary dysplasia in extremely preterm infants.
Lead researchers: Susan Donath with Omar Kamlin, Brett Manley and colleagues, Royal Women’s Hospital.
SONIC: Study of neck injuries in children
A large prospective observational study to develop a new or validate existing international clinical decision rules for children presenting to the emergency department with suspected cervical spinal injuries.
Completed projects
ViCBiostat: the Victorian Centre for Biostatistics, a Centre of Research Excellence in biostatistics
Originally funded by an NHMRC grant, ViCBiostat provided support for postdoctoral biostatisticians and PhD students working on a range of methodological research projects.
Lead researchers: John Carlin, Katherine Lee and Margarita Moreno-Betancur, MCRI, with Andrew Forbes, Rory Wolfe and Jessica Kazsa, Monash University, and Lyle Gurrin and Julie Simpson, University of Melbourne School of Population and Global Health.
Funding
Thank you to our supporters.
- National Health and Medical Research Council
- Australian Research Council
- Co-funding from the University of Melbourne
Collaborations
We partner with leading institutions worldwide, including:
- Professor Andrew Forbes, Professor Rory Wolfe & Dr Jessica Kasza, Biostatistics Group, Department of Epidemiology & Preventive Medicine, Monash University
- Professor Julie Simpson & Professor Lyle Gurrin, University of Melbourne School of Population & Global Health
- Dr Julie Marsh & Professor Steve Webb (Univ. of W.A.), Dr Lisa Yelland & Dr Tom Sullivan (Univ. of Adelaide) and other members of the Australian Clinical Trials Methodology network (AusTriM)
- Professor Ian White, MRC Clinical Trials Unit, University College London, U.K.
- Professor James Carpenter, London School of Hygiene and Tropical Medicine
- Professor Kate Tilling, University of Bristol
- Professor Stijn Vansteelandt, Ghent University, Belgium
- Professor Andrew Gelman, Columbia University, U.S.A.
Methodological research
Missing data
Lee KJ, Carlin JB, Simpson JA, Moreno-Betancur M. Assumptions and analysis planning in studies with missing data in multiple variables: moving beyond the MCAR/MAR/MNAR classification. Int J Epidemiol. 2023 Aug 2;52(4):1268-1275. doi: 10.1093/ije/dyad008. PMID: 36779333; PMCID: PMC10396404.
Mainzer RM, Moreno-Betancur M, Nguyen CD, Simpson JA, Carlin JB, Lee KJ. Gaps in the usage and reporting of multiple imputation for incomplete data: findings from a scoping review of observational studies addressing causal questions. BMC Med Res Methodol. 2024 Sep 4;24(1):193. doi: 10.1186/s12874-024-02302-6. PMID: 39232661; PMCID: PMC11373423.
Dashti SG, Lee KJ, Simpson JA, Carlin JB, Moreno-Betancur M. Handling Multivariable Missing Data in Causal Mediation Analysis Estimating Interventional Effects. Epidemiology. 2025 Jul 1;36(4):487-499. doi: 10.1097/EDE.0000000000001866. Epub 2025 Apr 1. PMID: 40167180.
Wijesuriya R, Moreno-Betancur M, Carlin JB, White IR, Quartagno M, Lee KJ. Multiple Imputation for Longitudinal Data: A Tutorial. Stat Med. 2025 Feb 10;44(3-4):e10274. doi: 10.1002/sim.10274. PMID: 39846338; PMCID: PMC11755704.
Casual inference
Moreno-Betancur M, Wijesuriya R, Carlin JB. The Ideal Trial: Defining Causal Estimands that Balance Relevance and Feasibility in Target Trial Emulations and Actual Randomized Trials. Epidemiology. 2026 Mar 1;37(2):153-162. doi: 10.1097/EDE.0000000000001933. Epub 2026 Jan 2. PMID: 41490058; PMCID: PMC12851543.
Downes M, O'Connor M, Olsson CA, Burgner D, Goldfeld S, Spry EA, Patton G, Moreno-Betancur M. Causal inference in multi-cohort studies using the target trial framework to identify and minimize sources of bias. Am J Epidemiol. 2025 Sep 3;194(9):2685-2697. doi: 10.1093/aje/kwae405. PMID: 39445353; PMCID: PMC12409135.
Chen T, Dashti SG, Moreno-Betancur M. medRCT: Causal mediation analysis estimating interventional effects mapped to a target trial in R. Journal of Open Source Software. 2025;10(110):8063. doi:10.21105/joss.08063
Carlin JB, Moreno-Betancur M. On the Uses and Abuses of Regression Models: A Call for Reform of Statistical Practice and Teaching. Stat Med. 2025 Jun;44(13-14):e10244. doi: 10.1002/sim.10244. PMID: 40553044; PMCID: PMC12186762.
Adaptive trials
Mahar R, Webb S, Marschner I, Forbes AB, Lee KJ. Platform trials: key features, when to use them and methodological challenges. Med J Aust. 2025 Aug 4;223(3):120-122. doi: 10.5694/mja2.52711. Epub 2025 Jun 22. PMID: 40545735; PMCID: PMC12318487.
Selman CJ, Lee KJ, Whitehead CL, Manley BJ, Mahar RK. Statistical analyses of ordinal outcomes in randomised controlled trials: protocol for a scoping review. Trials. 2023 Apr 21;24(1):286. doi: 10.1186/s13063-023-07262-8. PMID: 37085929; PMCID: PMC10119829.
Data Management
Stevens L, Kennedy N, Taylor RJ, Lewis A, Harrell FE Jr, Shotwell MS, Serdoz ES, Bernard GR, Self WH, Lindsell CJ, Harris PA, Casey JD. A REDCap advanced randomization module to meet the needs of modern trials. 2025 Nov;171:104925. doi: 10.1016/j.jbi.2025.104925. Epub 2025 Oct 4. PMID: 41052664; PMCID: PMC12977000.
Health and medical research
Trials
Nixon GM, Anderson D, Baker A, Davidson A, Griffiths A, Grobler AC, Pinczower G, Rimmer J, Rose E, Selman CJ, Simpson CM, Vandeleur M, Perrett KP. Intranasal Treatments for Children With Sleep-Disordered Breathing: The MIST+ Randomized Clinical Trial. JAMA Pediatr. 2026 Mar 1;180(3):240-249. doi: 10.1001/jamapediatrics.2025.5717. PMID: 41557344; PMCID: PMC12820777.
Pittet LF, Messina NL, Orsini F, Moore C, Bonnici R, Bonten M, Campbell J, Croda J, Dalcolmo M, Germano S, Gardiner K, Goodall C, Gwee A, Hall R, Jamieson T, Jardim B, Kollman TR, Lacerda MGV, Lee KJ, Lucas M, Lynn DJ, McDonald E, Manning L, Munns CF, Nicholson S, Perlen S, Perrett KP, Aymerich CP, Richmond P, Rodriguez-Baño J, dos Santos G, Teo JW, da Silva PV, Villanueva P, Warris A, Wood NJ, Davidson A, Curtis N & the BRACE trial Consortium Group. Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care Workers. NEJM, 2023. 388:1582-1596. DOI: 10.1056/NEJMoa2212616
Manley BJ, Kamlin COF, Donath SM, Francis KL, Cheong JLY, Dargaville PA, Dawson JA, Jacobs SE, Birch P, Resnick SM, Schmölzer GM, Law B, Bhatia R, Bach KP, de Waal K, Travadi JN, Koorts PJ, Berry MJ, Lui K, Rajadurai VS, Chandran S, Kluckow M, Cloete E, Broom MM, Stark MJ, Gordon A, Kodur V, Doyle LW, Davis PG, McKinlay CJD; PLUSS Trial Investigators. Intratracheal Budesonide Mixed With Surfactant for Extremely Preterm Infants: The PLUSS Randomized Clinical Trial. JAMA. 2024 Dec 10;332(22):1889-1899. doi: 10.1001/jama.2024.17380. PMID: 39527075; PMCID: PMC11555571.
Observational studies
Goldfeld S, Downes M, Gray S, Pham C, Guo S, O'Connor E, Redmond G, Azpitarte F, Badland H, Woolfenden S, Williams K, Priest N, O'Connor M, Moreno-Betancur M. Household income supplements in early childhood to reduce inequities in children's development. Soc Sci Med. 2024 Jan;340:116430. doi: 10.1016/j.socscimed.2023.116430. Epub 2023 Nov 18. PMID: 38048739.
Sawyer SM, Canterford L, Greenhalgh E, Ellul S, Vijayakumar N, Scollo M, Dashti SG. Tracking the course of vaping and cigarette smoking across adolescence: the Child to Adult Transition Study. Lancet Reg Health West Pac. 2025 Oct 21;64:101719. doi: 10.1016/j.lanwpc.2025.101719. PMID: 41209650; PMCID: PMC12589911.
Priest N, Guo S, Wijesuriya R, Chamberlain C, Smith R, Davis S, Mohamed J, Moreno-Betancur M. To what extent could eliminating racial discrimination reduce inequities in mental health and sleep problems among Aboriginal and Torres Strait Islander children? A causal mediation study. Lancet Reg Health West Pac. 2024 Oct 8;51:101196. doi: 10.1016/j.lanwpc.2024.101196. PMID: 39430685; PMCID: PMC11490864.